On August 10 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first half of 2016 (Press release, Evotec, AUG 10, 2016, View Source [SID:1234514464]).

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FINANCIAL PERFORMANCE -STRONG GROWTH TREND CONTINUES

– Significant revenue growth in both operating segments: EVT Execute revenues up 35% to EUR 79.8 m; EVT Innovate revenues up 44% to EUR 11.8 m

– Consolidated Group revenues grew by 37% to EUR 75.5 m (H1 2015: EUR 55.0 m); base revenues up 35% to EUR 68.5 m

– Adjusted Group EBITDA increased to EUR 15.8 m (H1 2015: EUR 0.8 m); adjusted EBITDA of EUR 22.5 m for EVT Execute (H1 2015: EUR 9.8 m)

– Increase in R&D expenses of 6% to EUR 9.0 m

– Strong liquidity position of EUR 118.3 m despite initiation of loan repayments in Q2 2016

EVT EXECUTE – STRONG AND PROFITABLE GROWTH

– Milestone achievements in Bayer, Boehringer Ingelheim and Padlock collaborations

– Collaboration extensions e.g. with Genentech and Janssen Pharmaceutica NV

– Multi-year compound management agreement with Pierre Fabre

– Antibiotic Research UK’s first research contract awarded to Evotec

– Continued strengthening of existing drug discovery platforms with e.g. Trianni’s next-generation transgenic technology and CRISPR/Cas9 licences

– Phase I clinical start for the treatment of endometriosis with Bayer (after period-end)

EVT INNOVATE – ACCELERATION OF FIRST-IN-CLASS TARGETS AND PLATFORMS

– Acceleration of TargetNASH programme funded by Ellersbrook GmbH & Co. KG

– Innovation partnership with ex scientia to develop bispecific small molecule immuno-oncology therapeutics

– Formation of spin-off company Topas Therapeutics GmbH in the field of nanoparticle-based therapeutics to treat immunological disorders; Series A funding of EUR 14 m completed

PROFITABILITY GUIDANCE RAISED (AFTER PERIOD-END)

– Adjusted Group EBITDA (before changes in contingent consideration) expected to more than double compared to 2015

– All other elements of financial guidance as of 22 March 2016 and positive outlook confirmed

1. FINANCIAL PERFORMANCE

STRONG GROWTH TREND CONTINUES

Evotec’s Group revenues for the first half of 2016 grew to EUR 75.5 m, an increase of 37% compared to the same period of the previous year (H1 2015: EUR 55.0 m). This increase is due to growth in the core EVT Execute business, the contribution of the Sanofi collaboration as well as milestone achievements. Excluding milestones, upfronts and licences, Evotec’s base revenues for the first half of 2016 were EUR 68.5 m and increased by 35% over the same period of the previous year (H1 2015: EUR 50.7 m). The gross margin amounted to 34.5% in the first six months of 2016 and improved over the first half of 2015 (H1 2015: 26.0%). The margin increase over 2015 is attributable to the same drivers as the trend in revenue growth.

R&D expenses for the first half of 2016 increased by 6% to EUR 9.0 m (H1 2015: EUR 8.5 m) due to an increase in the number of projects progressed in the portfolio. SG&A expenses for the first half of 2016 decreased by 5% to EUR 11.8 m (H1 2015: EUR 12.4 m). SG&A expenses in 2015 included one-time M&A and related costs. Adjusted Group EBITDA in the first six months of 2016 increased significantly to EUR 15.8 m (H1 2015: EUR 0.8 m). The EBITDA 2015 was adjusted by EUR 1.0 m for changes in contingent consideration. Evotec’s operating income for the first half of 2016 amounted to EUR 8.4 m (H1 2015: EUR 12.9 m).

Liquidity, which includes cash and cash equivalents (EUR 57.9 m) and investments (EUR 60.4 m) amounted to EUR 118.3 m at the end of June 2016 (31 December 2015: EUR 133.9 m). In Q2 2016, Evotec initiated the repayment of loans.

Revenues from the EVT Execute segment amounted to EUR 79.8 m in the first half of 2016, an increase of 35% compared to the same period of the previous year (H1 2015: EUR 59.2 m). Included in this amount are EUR 16.2 m of intersegment revenues (H1 2015: EUR 12.4 m). The EVT Innovate segment generated revenues in the amount of EUR 11.8 m consisting entirely of third-party revenues (H1 2015: EUR 8.2 m). The increase in revenues resulted from EVT Innovate projects which were partnered in H2 2015. Gross margin for EVT Execute amounted to 28.8% while EVT Innovate generated a gross margin of 50.0%. In line with Evotec’s strategy, R&D expenses for the EVT Innovate segment increased from EUR 10.4 m in the first six months of 2015 to EUR 11.9 m in the first six months of 2016 due to an increase in the number of projects progressed in the portfolio. In the first six months of 2016, the adjusted EBITDA of the EVT Execute segment of EUR 22.5 m significantly improved compared to the same period of the previous year (H1 2015: EUR 9.8 m). The EVT Innovate segment reported an adjusted EBITDA of EUR (6.6) m (H1 2015: EUR (9.0) m).

2. EVT EXECUTE & EVT INNOVATE

EVT EXECUTE – STRONG AND PROFITABLE GROWTH

The strong operational performance in the first quarter of 2016 successfully continued into the second quarter of 2016. In the first half 2016, important milestones were achieved in collaborations with Bayer, Boehringer Ingelheim and Padlock. Furthermore, a new multi-year compound management agreement with Pierre Fabre was signed. In addition, various collaborations were extended, such as the drug discovery alliance with Genentech for a further three years. Additionally, Janssen Pharmaceutica NV extended its proteomics collaboration with Evotec, now entering its tenth year. Evotec also continues to benefit from the recent trend of an increasing number of foundations requesting Evotec’s drug discovery platforms, e.g. Antibiotic Research UK awarded its first research contract to Evotec. The Company continued to expand its drug discovery platforms. Evotec acquired a non-exclusive licence to the leading technology on the market for gene editing (CRISPR-Cas9 licence). Trianni’s next-generation transgenic technology was also integrated into the offering of Evotec’s drug discovery platforms. After period-end, Evotec was able to announce that the first programme from the strategic alliance between Bayer and Evotec in the field of endometriosis was progressed into Phase I clinical development.

EVT INNOVATE – ACCELERATION OF FIRST-IN-CLASS TARGETS AND PLATFORMS

EVT Innovate showed a strong H1 2016 with very good scientific and commercial progress in the portfolio. EVT Innovate is accelerating its TargetNASH programme together with Ellersbrook GmbH & Co. KG. Ellersbrook and Evotec are committed to investing up to EUR 5 m over an initial three-year period. An innovation partnership with ex scientia (UK) to develop bispecific small molecule immuno-oncology therapeutics was formed. This highly innovative research project is mainly performed on Evotec’s oncology drug discovery platform in Toulouse.

In March 2016, Evotec announced the formation of a spin-off company called Topas Therapeutics GmbH, focused in the field of nanoparticle-based therapeutics to treat immunological disorders. The establishment of Topas is the first example of the acceleration of Evotec’s business model to take advantage of carving out or investing in promising programmes with additional upside potential.

Furthermore, good progress was reported in existing partnerships and development projects: The clinical studies for EVT201 and EVT401 in China are recruiting according to plan. The partnered pre-clinical oncology projects with Sanofi (e.g. EVT801) are progressing well towards clinical initiation in 2017.

3. PROFITABILITY GUIDANCE RAISED

Evotec’s financial guidance was updated in July 2016 due to an increased margin contribution and a positive outlook for the remainder of the year.

Guidance July 2016
Original Guidance 2016 Actual 2015

Group revenues1)

More than 15% growth

More than 15% growth

EUR 115.4 m
Adjusted Group EBITDA2)
More than double Positive and significantly improved compared to prior year

EUR 8.7 m

R&D expenses

Approx. EUR 20 m
Approx. EUR 20 m EUR 18.3 m

Liquidity3)
Similar level compared to 2015
Similar level compared to 2015 EUR 134.5 m

Capex investments

Up to EUR 10 m
Up to EUR 10 m EUR 11.2 m
1) Excluding milestones, upfronts and licences
2) Before contingent considerations, income from bargain purchase and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result
3) Excluding any potential cash outflow for M&A or similar transactions

On August 10, 2016 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported financial results and business highlights for the second quarter ended June 30, 2016 (Press release, Cyclacel, AUG 10, 2016, View Source [SID:1234514462]).

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The Company’s net loss applicable to common shareholders for the second quarter ended June 30, 2016 was $3.0 million, or $1.01 per basic and diluted share, compared to net loss applicable to common shareholders of $3.4 million, or $1.19 per basic and diluted share for the second quarter ended June 30, 2015. As of June 30, 2016, cash and cash equivalents totaled $15.9 million.

"Subsequent to the end of the quarter, we achieved a key milestone in our acute myeloid leukemia (AML) SEAMLESS Phase 3 study," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The required number of events has been reached and preparations for final analysis and reporting of SEAMLESS outcomes are underway. Over the next several weeks, we will complete data cleaning and validation operations after which the database will be transferred to our statistical analysis vendor. We will subsequently report outcomes for the primary (overall survival) and secondary endpoints and determination of submissibility of the SEAMLESS data set to regulatory authorities in Europe and the United States.

In our DNA damage response program, durable antitumor activity was reported at an oral presentation at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting with a combination of sapacitabine and seliciclib, our CDK2/9 inhibitor, in heavily pretreated patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations. A disease control rate of 35.6% was observed, with ongoing responding patients achieving treatment durations exceeding 1 and 4.7 years, respectively. We continue to enroll patients with solid tumors in a first-in-human, Phase 1 study of CYC065, our second-generation CDK2/9 inhibitor."

BUSINESS HIGHLIGHTS

SEAMLESS study

Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit or refused intensive chemotherapy, reached the number of events required for final analysis.
Preparations are underway for final analysis of study data.
DNA damage response program

Oral presentation of data at 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Phase 1 combination of sapacitabine and seliciclib as orally-administered treatment in 67 heavily-pretreated patients. Antitumor activity in subgroup of 45 patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations. Disease control rate of 35.6% (1 CR, 5 PR and 10 SD). No CR or PR observed in BRCA negative patients.
Ongoing extension cohort in BRCA positive patients with breast cancer.
Cyclin dependent kinase (CDK) inhibitor program

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors and lymphomas.
Corporate

Received notification from the Listing Qualifications Staff of NASDAQ that the Company regained compliance with the minimum bid price rule for continued listing on The NASDAQ Capital Market.
Effected a one-for-twelve reverse stock split of the Company’s outstanding shares of common stock.
Entered into an At Market Issuance Sales Agreement with FBR Capital Markets & Co. under which the Company may, from time to time, sell shares of the Company’s common stock.
Terminated Controlled Equity OfferingSM sales agreement with Cantor Fitzgerald & Co.
KEY UPCOMING MILESTONES

SEAMLESS study

Study database locked in preparation for final data analysis.
Report top-line data and determination of submissibility to regulatory authorities, anticipated in the fourth quarter 2016.
Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
DNA damage response program

Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
Plan to add Phase 1, part 3 to include BRCA mutation positive, pancreatic and ovarian cancer patients.
CDK Inhibitor Program

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors and lymphomas.
Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes (MDS):

Plan a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
SECOND QUARTER 2016 FINANCIAL RESULTS

Grant Revenue

Revenue for the three months ended June 30, 2016 was $0.2 million, compared to $0.3 million for the same period of the previous year. The revenue is related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.

Research and Development Expenses

Research and development expenses were $2.6 million for the three months ended June 30, 2016 and $2.6 million for the three months ended June 30, 2015.

General and Administrative Expenses

General and administrative expenses were $1.3 million for the three months ended June 30, 2016 and $1.3 million for the three months ended June 30, 2015.

Based on current plans, the Company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs through the first quarter of 2018.

On August 10, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the second quarter ended June 30, 2016 and provided an update on the Company’s corporate and operational highlights (Press release, Argos Therapeutics, AUG 10, 2016, View Source [SID:1234514461]).

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"The second quarter saw us continue to build on the accomplishments and momentum from the first quarter," said Jeff Abbey, president and chief executive officer. "In June, our Independent Data Monitoring Committee recommended the continuation of our ADAPT Phase 3 trial of our lead product candidate, AGS-003, in metastatic renal cell carcinoma. As a result of this positive decision, we were able to close on the $29.8 million second tranche of the financing we announced in March of this year. In addition, we were pleased to successfully complete a $50.0 million follow-on offering in early August. Together, these financings have provided the capital to advance key activities as we continue on the path toward our goal of becoming a fully-integrated commercial biotechnology company."

Mr. Abbey continued, "Specifically, we are advancing our plans for the build-out and equipping of a commercial manufacturing facility and expect to finalize our arrangements for the facility during the third quarter of 2016. We will then promptly begin the build out and equipping of the facility so that we will be in a position to submit a biologic license application (BLA) as expeditiously as possible following the availability of overall survival data from the ADAPT trial, provided that the data are supportive. We also intend to expand our clinical development activities in a measured manner as we explore additional oncology indications, including the ongoing trials of AGS-003 as neodjuvant therapy in renal cell carcinoma and in non-small cell lung cancer."

"In addition to our clinical development efforts with respect to AGS-003, during July the first patient was dosed in stage 2 of our adult eradication trial of AGS-004 in the treatment of HIV, which is the first clinical trial evaluating the ‘kick and kill’ approach employing a validated HIV latency-reversing drug combined with an individualized immunotherapy. We look forward to the results of this trial, as it represents another exciting opportunity for the application of our platform technology," added Mr. Abbey. "During the quarter, we were also pleased to announce our new research agreement with Adaptive Biotechnologies, which we believe will help to more precisely analyze target-specific immune activation enabled by Arcelis administration."

"Finally, we were pleased to announce the recent appointment of Dr. Richard D. Katz as chief financial officer," continued Mr. Abbey. "As a seasoned biotechnology finance executive, Rich brings a wealth of experience that will be extremely valuable as we continue to build the company and advance towards commercialization."

Second Quarter 2016 and Recent Operational Highlights:

In June 2016, the Independent Data Monitoring Committee (IDMC) recommended the continuation of the ADAPT Phase 3 study of AGS-003 in metastatic renal cell carcinoma
In June 2016, the company closed on the $29.8 million second tranche of March 2016 Financing
In June 2016, the company was added to the Russell 2000 Index
In June 2016, the company entered into a strategic research agreement with Adaptive Biotechnologies
In July 2016, announced the first patient had been dosed in the stage 2 of the adult eradication trial of AGS-004 in the treatment of HIV
In August 2016, the company completed a $50.0 million equity financing
Selected Second Quarter 2016 Financial Results

Net loss for the three months ended June 30, 2016 was $12.6 million, or $0.48 per share, compared to a net loss of $19.6 million, or $0.95 per share, for the same period in 2015. Net loss for the six months ended June 30, 2016 was $25.4 million, or $1.04 per share, compared to a net loss of $37.2 million, or $1.84 per share, for the same period in 2015.

Revenue for the three months ended June 30, 2016 totaled $0.5 million compared to $0.1 million for the same period in 2015. Revenue for the six months ended June 30, 2016 totaled $0.6 million compared to $0.3 million for the same period in 2015.

Research and development expense for the three months ended June 30, 2016 totaled $9.2 million compared to $16.1 million for the same period in 2015. Research and development expense for the six months ended June 30, 2016 totaled $18.7 million compared to $30.9 million for the same period in 2015.

General and administrative expense for the three months ended June 30, 2016 totaled $3.4 million compared to $2.9 million for the same period in 2015. General and administrative expense for the six months ended June 30, 2016 totaled $6.4 million compared to $5.3 million for the same period in 2015.

As of June 30, 2016, Argos’ cash, cash equivalents and short-term investments totaled $34.8 million compared to $7.2 million as of December 31, 2015.

Conference Call and Webcast Details

Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 60556076. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.