On August 10, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended June 30, 2016 and updates shareholders in regards to the upcoming date for the Company’s arbitration hearing against its former Clinical Research Organization (CRO) (Press release, Cel-Sci, AUG 10, 2016, View Source [SID:1234514501]).

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Key corporate and clinical developments during the quarter include:

Enrolled an additional 92 patients in the global pivotal Phase 3 head and neck cancer trial during the third quarter of FY 2016 which is a 12% increase over the third quarter of FY 2015.
Enrolled another 29 patients in July 2016, following the end of the quarter.
A total of 877 patients have been enrolled in the study as of July 31, 2016.
Continued patient enrollment in the Phase 1 trial of Multikine* in HIV/HPV co-infected men and women with peri-anal warts at San Diego Naval Medical Center and University of California, San Francisco (UCSF).
Raised $5 million to finance the Phase 3 head and neck cancer trial.
CEL-SCI’s net loss for the quarter ended June 30, 2016 was ($3,849,324) or ($0.03) per basic and diluted share, versus ($4,429,137) or ($0.05) per basic share and ($0.06) per diluted share during the quarter ended June 30, 2015. The net loss for the nine months ended June 30, 2016 was ($10,352,366) or ($0.09) per basic and diluted share, versus ($24,830,691) or ($0.32) per basic and diluted share during the same nine months ended June 30, 2015.

CEL-SCI reported an operating loss of ($6,382,747) for the quarter ended June 30, 2016 versus an operating loss of ($8,201,475) for the quarter ended June 30, 2015. The operating loss for the nine months ended June 30, 2016 was ($18,439,482) versus ($25,956,559) during the nine months ended June 30, 2015.

Geert Kersten, CEL-SCI’s Chief Executive Officer said, "The current focus remains the completion of the Phase 3 clinical trial with Multikine and the upcoming arbitration hearing ("trial") against the Company’s former CRO scheduled for September 7, 2016."

About Multikine (Leukocyte Interleukin, Injection)

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary (not yet treated) squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

On August 10, 2016 Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2016 and also provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 10, 2016, View Source [SID:1234514494]).

"We made significant progress advancing our clinical development programs during the second quarter. Specifically, we were pleased to announce a sponsored research agreement with Thomas Jefferson University to investigate our DNAbilize technology for the development of a brain cancer immunotherapy," said Peter Nielsen, President and CEO of Bio-Path Holdings. "In addition, we advanced preparations for the efficacy portion of our Phase II program of BP1001 for the treatment of acute myeloid leukemia (AML). We have seven leading cancer centers committed to conducting this trial and look forward to dosing patients in the near term."

Recent Corporate Highlights

· Entered Sponsored Research Agreement with Thomas Jefferson University. The Company entered into a sponsored research agreement with Thomas Jefferson University to investigate Bio-Path’s DNAbilize antisense DNA technology for the development of a brain cancer immunotherapy that works by activating the patient’s own immune system to fight the patient’s cancer.

· Completed Registered Direct Public Offering. On July 5, 2016, the Company completed the sale and issuance of 5,882,353 shares of common stock and warrants to purchase up to 2,941,177 shares of common stock in a registered direct offering with gross proceeds of approximately $10.0 million.

· Presented Data at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper). Dr. Maro Ohanian, Assistant Professor at The University of Texas MD Anderson Cancer Center, presented data at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. Results from the Phase I study of BP1001 for the treatment of AML and CML as well as the safety segment of the Phase II combination therapy of BP1001 in combination with low-dose cytarabine (LDAC) as a treatment for advanced AML were presented in a poster titled, "Phase I Study of BP1001 (Liposomal Grb2 Antisense) in Patients with Hematologic Malignancies."

· Presented Data at the 18th Annual TIDES: Oligonucleotide and Peptides Therapeutics Conference. In May, Dr. Ana Tari Ashizawa delivered a presentation titled, "Clinical Studies of BP1001, a drug candidate utilizing DNAbilize Antisense DNA Technology, in Hematologic Malignancies" at the 18th Annual TIDES: Oligonucleotide and Peptides Therapeutics Conference.

Financial Results for the Second Quarter Ended June 30, 2016

The Company reported a net loss of $1.9 million, or $0.02 per share, for the three months ended June 30, 2016, compared to a net loss of $1.1 million, or $0.01 per share, for the same period last year. The increase was primarily due to preparations related to the Company’s Phase II clinical trial for BP1001 in AML.

Research and development expenses for the three months ended June 30, 2016 increased to $1.2 million, compared to $0.6 million for the same period last year. General and administrative expenses for the three months ended June 30, 2016 increased to $0.8 million, compared to $0.6 million for the same period last year.

As of June 30, 2016, the Company had cash of $4.2 million, compared to $8.9 million at December 31, 2015. Net cash used in operating activities for the six months ended June 30, 2016 was $4.6 million compared to $2.8 million for the comparable period in 2015.

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On August 10, 2016 Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2016 financial results and recent business highlights (Press release, Kura Oncology, AUG 10, 2016, View Source;p=RssLanding&cat=news&id=2194722 [SID:1234514478]). In the company’s Phase 2 trial of tipifarnib in HRAS mutant solid tumors, positive clinical activity, including objective responses, has been observed in patients with head and neck squamous cell carcinomas and patients with salivary gland cancer. Based on these responses, enrollment will be expanded to an additional seven patients.

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"We are encouraged by the promising activity observed in patients with HRAS mutant solid tumors that supports the potential use of tipifarnib as a single agent to inhibit HRAS-mediated activation of the MAPK pathway to produce therapeutic responses," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "There are currently no approved treatments that specifically target HRAS mutations, and the activity we have seen in patients with HRAS mutant head and neck squamous cell carcinomas is particularly exciting. I am pleased with Kura’s progress to date in 2016 and look forward to providing additional updates on our ongoing activities as the year continues to unfold."

Update on Phase 2 Clinical Trial in HRAS Mutant Solid Tumors

Kura Oncology’s Phase 2 trial of tipifarnib in HRAS mutant solid tumors was designed to initially enroll two cohorts of 11 patients each with HRAS mutations, with the first cohort comprising patients with thyroid cancers and the second comprising patients with non-hematologic malignancies other than thyroid cancer. The primary objective of the study is to investigate the antitumor activity of tipifarnib in terms of objective response rate. Secondary objectives include progression-free survival, duration of response and safety. Per the protocol, two objective responses are required from the first 11 evaluable patients in a cohort in order to proceed to the second stage and enroll an additional seven patients.

In the second cohort, 11 evaluable patients have been enrolled to date with the most common histologies comprising salivary gland tumors (5 patients) and head and neck squamous cell carcinomas (3 patients).

Among the three patients with HRAS mutant head and neck squamous cell cancer, two patients have had confirmed partial responses (PR), and disease stabilization has been observed in the third patient. The two patients with PR’s have been on study for more than 12 and 5 months, and responses were seen after 6 and 2 cycles of treatment, respectively. The third patient demonstrated disease stabilization for 7 months.

No objective responses have been observed in patients with salivary gland tumors; however, 3 of 5 salivary gland cancer patients experienced disease stabilization beyond 6 months (>6, 9 and >11 months).

The first cohort of the Phase 2 trial, which consists of patients with thyroid cancers with HRAS mutations, continues enrolling.
Upcoming Clinical and Preclinical Milestones for Kura Oncology Programs

Initiation of a Phase 2 clinical trial for tipifarnib in patients with CMML is planned in the second half of 2016.

IND submission for ERK inhibitor, KO-947, is anticipated in the second half of 2016.

Nomination of a development candidate for the menin-MLL program is anticipated in the second half of 2016.
Financial Results for the Second Quarter 2016

Cash, cash equivalents and short-term investments totaled $80.1 million as of June 30, 2016, compared with $85.7 million as of December 31, 2015. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2018.

Research and development expenses for the second quarter of 2016 were $4.9 million, compared to $4.4 million for the second quarter of 2015.

General and administrative expenses for the second quarter of 2016 were $1.9 million, compared to $1.5 million for the second quarter of 2015.

Net loss for the second quarter of 2016 was $6.7 million, or $0.36 per share, compared to a net loss of $5.6 million, or $0.54 per share, for the second quarter of 2015.

During the second quarter of 2016, as previously disclosed, Kura Oncology put in place a $20.0 million term loan facility, of which $7.5 million has been drawn to date.

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.