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 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 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 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.

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.