On August 8, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported its financial results for the second quarter and the first six months 2018 ending June 30 (Press release, Epigenomics, AUG 8, 2018, View Source [SID1234528654]).

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"While we continue to pursue our objective of Medicare coverage for Epi proColon in the U.S., we are moving forward with our innovative liver cancer surveillance test", said Greg Hamilton, CEO of Epigenomics AG. "Based on the recently published excellent clinical data, this new blood-test could provide the next major opportunity for our company. Obtaining CE mark by year-end will be a key milestone for the product."

Q2/6M 2018 Financial Results

-Total Q2 2018 revenue increased to EUR 0.5 million (Q2 2017: EUR 0.2 million) and 6M 2018 revenue grew to EUR 0.8 million (6M 2017: EUR 0.5 million) due to higher revenue in the United States and license payments made by our partner in China.

-Product revenue in Q2 2018 increased by 65% to EUR 0.3 million (Q2 2017: EUR 0.2 million). In the six month period 2018, product revenue increased by 56% to EUR 0.4 million (6M 2017: EUR 0.2 million).

-Adjusted for non-cash expenses related to share-based payment expenses, EBITDA in Q2 2018 was at EUR -2.2 million (Q2 2017: EUR -3.4 million); adjusted EBITDA for 6M 2018 amounted to EUR -5.4 million (6M 2017: EUR -5.8 million). The lower EBITDA loss is mainly due to increased revenue and lower SG&A expenses.

-Net loss amounted to EUR 2.6 million in Q2 2018 compared to EUR 4.1 million in Q2 2017, and EUR 5.8 million for 6M 2018 (6M 2017: EUR 6.5 million). Net loss per share for Q2 2018 decreased to EUR 0.11 (Q2 2017: EUR 0.18) and for 6M 2018 to EUR 0.24 (6M 2017: EUR 0.28).

-Cash consumption (cash outflow from operating and investing activities) was EUR 4.2 million in 6M 2018 compared to EUR 4.7 million in 6M 2017.

-Liquid assets (including marketable securities) amounted to EUR 9.4 million at the reporting date (December 31, 2017: EUR 7million).

Operational highlights

-Centers for Medicare & Medicaid Services published preliminary rate for Epigenomics’ colorectal cancer screening test Epi proColon: The Centers for Medicare & Medicaid Services (CMS) published a preliminary reimbursement rate of $192 per Epi proColon test. Based on the proposed preliminary rate, CMS will determine the final rate. The publication of the final rate is expected in November 2018.

-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.

-Liquid biopsy test for liver cancer detection to obtain CE mark: Epigenomics announced it’s plan to CE mark the mSEPT9 blood test by year-end 2018 as an aid in detecting liver cancer among patients with cirrhosis. In 2019, the Company also plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China. Epigenomics estimates the liver cirrhosis surveillance market to be in excess of 10 million tests per year making it more than a three billion Euro market opportunity globally.

Outlook 2018 confirmed

-The Company confirms the outlook for the financial year 2018 as provided in its Annual Report 2017.

-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 interim report for the first six months 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 2.30 pm CET / 8.30 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 598060
USA: +1 516-269-8983

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 August 8, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the second quarter ended June 30, 2018 (Press release, Tracon Pharmaceuticals, AUG 8, 2018, View Source [SID1234528546]).

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Second Quarter 2018 and Recent Corporate Highlights

In August, we submitted an amendment to the FDA for the Phase 3 TAPPAS trial of TRC105 for the treatment of angiosarcoma that is accruing at 26 sites in the United States and multiple sites in the United Kingdom and France. The amendment proposes an increase in the trial sample size to account for the fewer than expected number of events that define the endpoint of progression free survival, reflecting a higher than expected rate of withdrawal for progressive disease unconfirmed by central review. The amendment increases the number of patients analyzed at the interim analysis from 70 to 120. Although the trial is enrolling at a higher rate than expected, with more than 80 patients enrolled, the amendment is expected to delay the interim analysis until Q1 2019.

In July, we completed enrollment in the Phase 1 portion of a Phase 1/2 trial of TRC253 and determined the recommended Phase 2 dose for patients with metastatic prostate cancer. Dosing in the Phase 2 portion of the trial commenced in August. The Phase 1/2 trial is designed to assess safety, determine the recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. If Janssen opts to reacquire TRC253 prior to or following completion of the Phase 1/2 trial, TRACON is entitled to receive a $45.0 million opt-in payment, up to $137.5 million in potential milestone payments and a low-single digit royalty.

In June, preclinical data from two murine models assessing the activity of TRC105 in combination with a PD-1 antibody were presented at the 2018 International Cancer Microenvironment Society meeting. The combination of treatment with TRC105 and the PD-1 antibody significantly reduced tumor volume compared to treatment with either individual therapy in both tumor models. Survival was significantly improved with combination treatment versus the individual therapies, with long-term survival demonstrated in 30% to 60% of animals. Combination treatment also increased tumor specific T cells, indicating stimulation of an immune response. TRC105 is being developed with the PD-1 checkpoint inhibitor Opdivo in patients with lung cancer in a Phase 1 trial.

In April, TRACON closed a private placement of its common stock and warrants providing aggregate gross proceeds of approximately $38.7 million. In conjunction with the financing, the Company appointed Ted Wang, Ph.D., Chief Investment Officer of Puissance Capital Management, to its Board of Directors.
"We anticipate significant news flow over the next few quarters with three major data events from TRC105 trials, including two randomized data points: top-line Phase 2 data in renal cell carcinoma and interim Phase 3 results in angiosarcoma" said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We continue to be encouraged by the rapid rate of accrual into the Phase 3 TAPPAS angiosarcoma trial."

Expected Upcoming Milestones

Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected prior to the end of 2018.

Announcement of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected prior to the end of 2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in Q1 2019.
Second Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments were $53.4 million at June 30, 2018, compared to $34.5 million at December 31, 2017. We expect our current cash, cash equivalents and short-term investments to fund operations into Q4 2019.

Research and development expenses for the second quarter of 2018 were $8.1 million compared to $4.9 million for the second quarter of 2017. The increase was primarily attributable to increased TRC105 drug manufacturing activities in the second quarter of 2018 as compared to the 2017 period.

General and administrative expenses for the second quarter of 2018 were $1.6 million compared to $2.1 million for the second quarter of 2017.

Net loss for the second quarter of 2018 was $9.8 million compared to $6.6 million for the second quarter of 2017.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its second quarter of 2018. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 3189378. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR

On August 8, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported its financial results for the second quarter and six months ended June 30, 2018 (Press release, Foamix, AUG 8, 2018, View Source [SID1234528609]).

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Clinical and Corporate Update:

The final patient was enrolled and dosed in the third Phase 3 study (FX2017-22) investigating FMX101, the Company’s minocycline foam 4%, in patients with moderate-to-severe acne.
Top-line results are expected in the third quarter of 2018.
The final patient has been enrolled and dosed in two Phase 3 clinical studies (FX2016-11 and FX2016-12) evaluating the safety and efficacy of FMX103, topical minocycline foam 1.5%, for the treatment of papulopustular rosacea.
Top-line results are expected early in the fourth quarter of 2018.
In April 2018, the Company raised net proceeds of approximately $16.1 million, through a direct registered offering of approximately 2.9 million shares at a price of $5.50 per share to OrbiMed Partners Master Fund Limited.
Cash & Investments
At June 30, 2018, the Company had $56.4 million in cash and investments compared to $76.4 million at December 31, 2017. During the second quarter, the Company raised net proceeds of $16.1 million, after deducting offering expenses, in a registered share offering with OrbiMed Partners Master Fund Limited. The Company believes that its existing cash and investments will be sufficient to fund operating expenses and capital expenditure requirements for the third Phase 3 clinical trial for FMX101 and NDA filing for FMX101, and for the two Phase 3 clinical trials for FMX103, which it expects to complete in 2019.

Financial Results for the Second Quarter Ended June 30, 2018
Revenues
Revenues for the second quarter of 2018 were $964,000 an increase of $166,000, or 20.8%, from $798,000 in the second quarter of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea Foam (azelaic acid 15%).

Operating Expenses
Research and Development Expenses
Research and development expenses for the second quarter were $16.8 million, a $2.9 million, or 20.9%, increase from $13.9 million in the second quarter of 2017. The increase in R&D expenses resulted primarily from an increase of $3.0 million in costs relating predominantly to FMX101 and FMX103 clinical trials, and an increase of $688,000 in payroll and payroll-related expenses including share-based compensation primarily due to an increase in headcount and salary raises, off-set by a decrease of $1.0 million in compensation to one of the Company’s co-founders in the second quarter of 2017.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the second quarter of 2018 were $2.9 million, a decrease of $542,000, or 15.5%, compared to $3.5 million in the second quarter of 2017. The decrease in selling, general and administrative expenses resulted primarily from a decrease of $1.2 million in compensation to one of the Company’s co-founders in the second quarter of 2017, off-set by an increase of $280,000 in payroll and other payroll-related expenses including share-based compensation mostly due to an increase in headcount and salary raises, an increase of $360,000 in advisory and professional fees and an increase of $150,000 in rent, maintenance and office expenses.

Net Loss
For the quarter ended June 30, 2018, the Company recorded a net loss of $18.6 million, or ($0.46) per share, basic and diluted, compared with a loss of $16.4 million or ($0.44) per share, basic and diluted, for the three months ended June 30, 2017.

Financial Results for the First Half Ended June 30, 2018
Revenues
Revenues for the six months ended June 30, 2018 were $1.9 million, an increase of $145,000, or 8.4%, from $1.7 million in the first six months of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea Foam.

Operating Expenses
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2018 were $39.7 million, a $13.1 million, or 49.2%, increase from $26.6 million in the first six months of 2017. The increase in research and development expenses resulted primarily from an increase of $12.2 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation primarily due to a change in the measurement of share-based compensation expenses of a consultant and an increase in headcount and salary raises, off-set by a decrease of $1.2 million in compensation to one of the Company’s co-founders in the first half of 2017 and an increase of $383,000 in travel-related expenses.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the six months ended June 30, 2018 were $6.7 million, an increase of $437,000, or 6.9%, compared to $6.3 million in the same six month period of 2017. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation, mostly due to an increase in headcount, salary raises and accounting modification relating to share-based compensation expenses of a consultant, off-set by a decrease of $1.5 million in compensation to one of the Company’s co-founders in the first half of 2017; an increase of $526,000 in advisory and professional services expenses, off-set by a decrease of $112,000 in travel-related expenses.

Net Loss
For the six months ended June 30, 2018, the Company recorded a net loss of $44.6 million, or ($1.15) per share, basic and diluted, compared with a loss of $30.8 million, or ($0.82) per share, basic and diluted, for the six month ended June 30, 2017.

On August 8, 2018 Unum Therapeutics Inc. (NASDAQ:UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, reported that management will present at two upcoming investor conferences (Press release, Unum Therapeutics, AUG 8, 2018, View Source [SID1234528768]):

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2018 Wedbush PacGrow Healthcare Conference on Wednesday, August 15, 2018 at 10:20 a.m. ET in New York, NY
Wells Fargo Securities 2018 Healthcare Conference on Thursday, September 6, 2018 at 10:55 a.m. ET in Boston, MA
Both presentations will be webcast live, and available for replay on the "Events" section of Unum’s investor relations webpage (investors.unumrx.com/events).

On August 8 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the second quarter ended June 30, 2018 (Press release, Akebia, AUG 8, 2018, View Source [SID1234528547]).

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"In the second quarter, we continued to drive our Phase 3 vadadustat program while executing on our long-term growth strategy with the announcement of the pending merger with Keryx Biopharmaceuticals," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "The combination is expected to create a fully-integrated company focused on the development and commercialization of therapeutics for patients with kidney disease. We are actively engaged in integration planning and continue to target the closing of the transaction by the end of 2018."

Second Quarter 2018 and Recent Corporate Highlights

Merger Announcement:

The definitive merger agreement with Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) was announced, offering potential operating and product portfolio synergies and the opportunity to create significant value and accelerate the growth potential beyond what either company would achieve separately;
The combined company will have an expanded and highly complementary nephrology portfolio, with Auryxia (ferric citrate), a U.S. Food and Drug Administration (FDA)-approved product in two indications with significant growth opportunity, and vadadustat, an investigational late-stage hypoxia-inducible factor prolyl hydroxylase inhibitor, which has the potential to provide a new oral standard of care to patients with anemia due to chronic kidney disease (CKD);
The combined company will have an established renal development, manufacturing and commercial organization, positioning it as a partner of choice for the renal community and for companies developing renal products; and
The combined company plans to leverage its leadership’s extensive expertise in the commercial renal market with the goal of maximizing sales of Auryxia while driving launch momentum for vadadustat in the United States, subject to FDA approval.
Clinical Development:

Completed U.S. enrollment of the Phase 3 INNO2VATE Conversion study, targeting full enrollment of the INNO2VATE program globally by the end of 2018. The company expects top-line results for the program in the fourth quarter of 2019 or the first quarter of 2020, subject to the accrual of major adverse cardiac events (MACE);
Continued to enroll subjects in the Phase 3 PRO2TECT program, with top-line results anticipated in mid-2020, subject to the accrual of MACE;
Initiated the Phase 2 FO2RWARD-2 study in dialysis dependent patients with anemia due to CKD, with top-line results expected in the first half of 2019. Results from this study are expected to provide additional characterization and differentiation of vadadustat and may further strengthen the company’s commercial position, subject to vadadustat’s regulatory approval; and
Completed a type-C meeting with the FDA, in which Akebia and the agency aligned on the statistical analysis plan in advance of a planned NDA filing for vadadustat.
Financial Results

Akebia reported a net loss of $34.1 million, or ($0.60) per share, for the second quarter of 2018 as compared to a net loss for the second quarter of 2017 of $21.5 million or ($0.53) per share.

Collaboration revenue was $48.8 million for the second quarter of 2018 compared to $28.5 million for the second quarter of 2017. Collaboration revenue recognized in the second quarter of 2018 related to revenue recognized under both the collaboration agreement with Otsuka Pharmaceutical Co. Ltd., or Otsuka, related to the United States, or the Otsuka U.S. Agreement, and the collaboration agreement with Otsuka related to Europe, China and certain other regions, or the Otsuka International Agreement, as well as revenue recognized in connection with the collaboration agreement with Mitsubishi Tanabe Pharma Corporation. Collaboration revenue recognized in the second quarter of 2017 only related to the Otsuka U.S. Agreement and the Otsuka International Agreement, which were consummated in December 2016 and April 2017, respectively.

Research and development expenses were $71.9 million for the second quarter of 2018 compared to $43.8 million for the second quarter of 2017. The increase was primarily attributable to external costs related to the continued advancement of the global PRO2TECT and INNO2VATE Phase 3 programs, including enrollment; and the manufacture of drug substance and drug product in support of the global Phase 3 program. Research and development expenses were further increased by headcount and compensation-related costs.

General and administrative expenses were $12.5 million for the second quarter of 2018 compared to $6.9 million for the second quarter of 2017. The increase was primarily attributable to an increase in costs to support the company’s research and development programs, including headcount and compensation-related costs, and costs incurred related to the proposed merger with Keryx Biopharmaceuticals.

Akebia ended the second quarter of 2018 with cash, cash equivalents and available for sale securities of $402.1 million. The company also generally receives cost-share funding from its collaboration agreements with Otsuka on a prepaid quarterly basis. Akebia expects its existing cash resources, including the prepaid quarterly committed cost-share funding from its collaborators, to fund its current operating plan into the first quarter of 2020.

Conference Call and Webcast

Akebia management will host its second quarter 2018 investor update conference call and webcast beginning at 4:30 p.m. Eastern Time today, Wednesday, August 8, 2018.

Individuals interested in participating in the call should dial (877) 458-0977 (U.S. and Canada) or (484) 653-6724 (international) using conference ID number 1398303. To access the webcast, visit the Investors section of Akebia’s website at www.akebia.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

Beginning the morning of August 9, 2018, the call will be available for replay via telephone and the archived webcast will be available on Akebia’s website. To listen to the telephone replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 1398303. The telephone replay will be available for six days following the call.