Bio-Path Holdings to Announce First Quarter 2018 Financial Results on May 16, 2018

On May 9, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Wednesday, May 16, 2018 at 8:30 a.m. ET to report financial results for the first quarter ended March 31, 2018 and to provide a business overview (Press release, Bio-Path Holdings, MAY 9, 2018, View Source [SID1234526361]).

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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 1096178. A live audio webcast of the call will also be available on the Presentations section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

MediciNova Announces Opening of Investigational New Drug Application for MN-166 (ibudilast) in Glioblastoma

On May 9, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for treatment of glioblastoma (GBM) has been accepted and is now open with the U.S. Food and Drug Administration (FDA) (Press release, MediciNova, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348327 [SID1234526377]). MediciNova was informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) in combination with temozolomide (TMZ) for treatment of GBM may proceed.

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"We are very pleased that this important regulatory step is now completed, as we can now pursue clinical development of MN-166 in GBM, a devastating type of cancer with a high recurrence rate and very poor prognosis. As we previously reported, combination treatment of MN-166 (ibudilast) and TMZ improved survival compared to TMZ-only treatment in a GBM animal model study," commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.

About GBM (glioblastoma)

According to the American Association of Neurological Surgeons, glioblastoma (GBM) is an aggressive, extremely lethal form of brain malignancy that develops from glial cells (astrocytes and oligodendrocytes) and rapidly grows and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents 15% of all brain tumors and 56% of all gliomas and has the highest number of cases of all malignant tumors, with an estimated 12,760 new cases predicted for 2018. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy, and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with GBM. Median survival is 14.6 months and two-year survival is 30%. Only approximately 5% of GBM patients survive longer than 36 months.

About MN-166

MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterases (PDE) 4 and 10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in substance use disorders, neurodegenerative diseases (e.g., ALS and progressive MS), and chronic neuropathic pain. MediciNova is developing MN-166 for various neurological conditions such as progressive MS, ALS and substance abuse/addiction.

Stemline Therapeutics Reports First Quarter 2018 Financial Results

On May 9, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported financial results for the quarter ended March 31, 2018 (Press release, Stemline Therapeutics, MAY 9, 2018, View Source [SID1234526393]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

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SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

In April, we announced initiation of a rolling Biologics License Application (BLA) submission for SL-401, and expect to complete the rolling submission in 2Q18.
If our BLA is successful, we anticipate possible U.S. approval of SL-401 in the 4Q18/1Q19 timeframe.
In preparation for possible approval, we continue to build out our pre-launch and commercial activities.
At the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, we are sponsoring a BPDCN disease awareness booth designed to continue to build awareness around BPDCN and CD123.
We anticipate feedback from the European Medicines Agency (EMA) regarding a potential regulatory filing in Europe, later this year.
Additional Clinical Trials

SL-401 is also being evaluated in clinical trials in additional indications including myeloproliferative neoplasms (MPN) [focused on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF)], acute myeloid leukemia (AML), and multiple myeloma.
We are evaluating possible registration-directed trial designs in CMML and MF given the results observed to date. Updates relating to these programs are expected later this year.
SL-801: the Phase 1 trial in patients with advanced solid tumors is ongoing, and dose escalation continues. Data from the SL-801 trial were selected for presentation at the upcoming ASCO (Free ASCO Whitepaper) meeting in June.
SL-701: the Phase 2 trial in patients with second-line glioblastoma has completed. Data from the SL-701 trial were selected for presentation at the upcoming ASCO (Free ASCO Whitepaper) meeting in June.
Ivan Bergstein, MD, CEO of Stemline, commented "The initiation of our rolling BLA submission advances us ever closer to potential approval and commercialization of SL-401. We continue to build out our commercial infrastructure, including accelerating efforts to raise awareness around BPDCN and CD123. In parallel, we continue to pursue SL-401 in other CD123 positive malignancies and look forward to forging additional registrational opportunities. We expect clinical updates from each of our pipeline candidates this year – all with an eye towards achieving our goal of improving the lives of patients with cancer and building a leading biopharmaceutical company."

First Quarter 2018 Financial Results Review
Stemline ended the first quarter of 2018 with $106.2 million in cash, cash equivalents and investments, as compared to $66.2 million as of December 31, 2017, which reflects a cash increase of $40.0 million for the quarter. The $40.0 million increase in cash represents the $55.7 million in net cash proceeds received from the Company’s follow-on public offering during January 2018 offset by $15.7 million of net cash expenditures during the first quarter 2018. The Company ended the first quarter of 2018 with 30.2 million shares outstanding.

For the first quarter of 2018, Stemline had a net loss of $18.4 million, or $0.69 per share, compared with a net loss of $14.6 million, or $0.67 per share, for the same period in 2017.

Research and development expense was $12.7 million for the quarter ended March 31, 2018, compared with $9.6 million for the quarter ended March 31, 2017, representing an increase of $3.1 million. The higher costs are primarily driven by an increase in regulatory and manufacturing expenses in support of our BLA filing and potential commercialization of SL-401.

General and administrative expense was $5.9 million for the quarter ended March 31, 2018, compared with $5.4 million for the quarter ended March 31, 2017, representing an increase of $0.5 million. The increase in expense was due to $0.9 million in higher pre-launch expenses in support of preparing for a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is received. Additionally, the higher costs also resulted from a $0.9 million increase in non-cash stock-based compensation expense and increased headcount. Partially offsetting the higher costs was a decrease in legal expenses of $1.3 million.

About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO (Free ASCO Whitepaper) 2018 and www.bpdcninfo.com.

10-Q – Quarterly report [Sections 13 or 15(d)]

Arcus Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Arcus Biosciences, 2018, MAY 9, 2018, View Source [SID1234527532]).

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CP Tianqing’s blockbuster innovative drug Anlotinib Hydrochloride Capsules Approved for Marketing

On May 9, 2018 Chia Tai Tianqing Pharmaceutical Group reported the 1.1-type new drug Anlotinib Hydrochloride Capsules (Focavi) obtained the registration approval document approved by the State Drug Administration (Press release, Jiangsu Chia-tai Tianqing, MAY 9, 2018, View Source [SID1234576212]). This marks the official launch of Anlotinib, an original and innovative drug in the Chinese oncology field that has received much attention. Wang Shanchun, president of CP Tianqing Pharmaceutical Group, said: "We expect that this new national drug will benefit more Chinese patients and even patients around the world after it is launched."

Anlotinib refers to advanced non-small cell lung cancer

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After more than 10 years of hard work, the R&D team of CP Tianqing finally made a breakthrough in the development of oncology drugs. The 1.1-type new drug Anlotinib Hydrochloride Capsules was approved for marketing. This product is a new type of small molecule multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, and has the dual effects of anti-tumor angiogenesis and inhibiting tumor growth. Clinical trials have confirmed that Focavi is the only effective single-drug oral preparation among the anti-angiogenesis targeted drugs for advanced non-small cell lung cancer, and its adverse reactions are relatively mild, and it is well tolerated by patients. According to analysis by industry experts, Anlotinib is expected to become the standard drug for the third-line treatment of patients with advanced non-small cell lung cancer.

"The listing of Anlotinib is also due to the ongoing reform measures for drug review and approval by the State Food and Drug Administration. As clinical studies have shown that Anlotinib has obvious clinical advantages over existing treatments, after the application That is, it was included in the priority review sequence by the drug review center. It is precisely because of the attention of the drug review department and the review experts working overtime that Anlotinib completed the marketing review and was approved in a short period of time. This will enable the majority of patients to use safe and effective anti-tumor innovative drugs as soon as possible." Wang Shanchun believes that the drug review period coincides with the national drug review and approval policy reform period, and the country’s orientation to encourage R&D and innovation is becoming more and more obvious. The approval of innovative drugs with outstanding clinical value such as Anlotinib has been guaranteed and encouraged. Through the priority review procedure, the Center for Drug Evaluation has provided an effective guarantee for meeting clinical drug needs, reducing drug costs, and promoting public health.

The clinical research results show that Focavi not only has a good therapeutic effect on non-small cell lung cancer, but also on soft tissue sarcoma, ovarian cancer and other cancers. CT Tianqing is actively carrying out multi-center clinical research including the United States. . The results of the Phase 2b clinical study of Anlotinib in the treatment of soft tissue sarcoma were reported orally by ASCO (Free ASCO Whitepaper) this year, and the results of the pathological subgroup of the Phase 3 clinical study for the treatment of non-small cell lung cancer were displayed in the ASCO (Free ASCO Whitepaper) this year, and were written into the "2018 CSCO Lung Cancer Guidelines" . Wang Shanchun said: "It is not easy for China’s original innovative drugs to have won such an honor before they went on the market. This shows the international recognition of Chinese innovative drugs."

Malignant tumors are the unbearable weight of life

There are more than 4 million new cancer patients in China each year, and an average of more than 10,000 people are diagnosed as new patients every day, and the incidence rate is increasing year by year. In particular, lung cancer ranks first in morbidity and mortality among men, and second in morbidity and mortality among women. The five-year survival period of cancer patients is much lower than the average in developed countries.

As an ordinary citizen, once diagnosed with a malignant tumor disease, not only the patient himself will suffer both physical and mental torture, loss of hope of survival, loss of dignity of life, but also a family may be crushed by this, and bear a heavy burden from then on The unbearable spiritual and economic burden. As an enterprise with a social conscience, CP Tianqing is also working hard, hoping to one day conquer the persistent disease of malignant tumors through technological innovation.

In recent years, with the development of traditional chemotherapy, targeted therapy and immunotherapy have successively entered first-line and second-line treatment, and the treatment of advanced non-small cell lung cancer has been greatly improved. However, for Chinese patients who have failed first-line and second-line treatments, the existing third-line treatments are relatively lacking and the choices are confusing, and patients are often in the predicament of no medicines available. In this case, the new small molecule multi-target tyrosine kinase inhibitor anlotinib independently developed by CT Tianqing has finally succeeded, providing an effective new method for the third-line treatment of patients with advanced non-small cell lung cancer in China. treatment method.

CP Tianqing has a rich product line in the anti-tumor field

The listing of Anlotinib can be said to be a milestone event in the development history of CP Tianqing. The drug is Chia Tai Tianqing’s first innovative small molecule drug in accordance with international R&D procedures and standards, and it is also the company’s most invested anti-cancer drug so far. The successful listing of Anlotinib marks a solid step forward by CP Tianqing from "combination of imitation and innovation" to "combination of innovation and imitation". It is also a major breakthrough in the oncology field of the company based on the "focus on liver disease" strategy. .

Chia Tai Tianqing Pharmaceutical Group is an innovative pharmaceutical group enterprise integrating scientific research, production and sales. It is a well-known liver health drug research and development and production base in China. It is a national key high-tech enterprise and a national Torch Plan Lianyungang new pharmaceutical industry base. The backbone enterprise ranks 16th among the top 100 enterprises in China’s pharmaceutical industry. Chia Tai Tianqing currently invests more than 10% of its sales revenue every year. It has more than 1,000 R&D personnel and more than 180 products under research, including more than 40 innovative drugs and more than 20 biological drugs.

It is reported that in addition to the field of strong liver diseases, CP Tianqing has also formed a unique product line in the field of anti-tumor. Hematological tumor products Decitabine, Imatinib, and Dasatinib are the first imitation products in China. In the next three years, CP Tianqing will launch more products in the oncology field, such as bortezomib, bendamustine, lenalidomide, azacitidine, etc., to improve drug accessibility and quality of life for cancer patients.