On March 8, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, is pleased reported that the Company has selected Theradex as its contract research organization (CRO) for both the planned Phase 2 clinical trials evaluating the experimental immunotherapeutic vaccine ProscaVax for prostate cancer, one at Urology Centers of North Texas (UCNT) and the other at Harvard University teaching hospitals (Press release, Oncbiomune, MAR 8, 2018, View Source [SID1234525399]).

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Theradex served as the CRO for the successfully completed Phase 1a trial of ProscaVax hosted at the University of California San Diego Moores Cancer Center and the Veterans Hospital in La Jolla, California.
In the UCNT trial, ProscaVax, the Company’s lead drug candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), will be evaluated in a similar patient population as the Phase 1a trial, hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA. The Phase 2 study at the University will be the first mid-stage trial of its type that the Company is aware of, with ProscaVax being administered as a front-line treatment for patients in "active surveillance," meaning they are in the early stage of disease, have received no treatment for their prostate cancer and are only working with their oncologist to monitoring the cancer for signs of progression.

"Experts in oncology and the clinical process, Theradex was invaluable to us in the initial trial of ProscaVax and we’re certain that their experience and guidance will again be of utmost importance in the planned mid-stage studies," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "What we are trying to achieve by addressing prostate cancer at the earliest stage and in the most advanced stage is critically important to improving patient care in a cancer with very limited options across the disease spectrum. We look forward to working with Theradex again and to getting these studies underway."

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On March 8, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2017 (Press release, Curis, MAR 8, 2018, View Source [SID1234524538]).

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"2017 exemplified Curis’s business strategy, marking the Company’s first time with three anti-cancer drug candidates in clinical development" said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "We are excited about CUDC-907 treatment providing durable responses in nearly 1 in 4 DLBCL patients whose cancers have MYC alterations. We are working closely with regulatory authorities to define a pivotal path to register CUDC-907 in this patient population, which has no viable treatment options."

"Our progress with testing CA-170, the first and only oral small molecule checkpoint inhibitor, has now extended beyond the Phase 1 trial, with our partner Aurigene having initiated a Phase 2 trial in India. This will greatly accelerate access to select populations of patients that have not experienced prior immunotherapy."

"As noted, with initiation of patient enrollment in CA-4948’s Phase 1 lymphoma study, for the first time, Curis has 3 different cancer drugs in clinical testing at the same time. We are excited about the prospects for these drugs and their value to Curis’s success in 2018."

Full Year and Fourth Quarter 2017 Financial Results

For the year ended December 31, 2017, Curis reported a net loss of $53.3 million, or $(0.36) per share on both a basic and diluted basis, as compared to a net loss of $60.4 million, or $(0.45) per share on both a basic and diluted basis in 2016. For the fourth quarter of 2017, Curis reported a net loss of $8.0 million or $(0.05) per share on both basic and diluted basis, as compared to a net loss of $11.3 million, or $(0.08) per share on both basic and diluted basis for the same period in 2016. The net loss for the year ended December 31, 2016, includes a non-cash in-process research and development charge of $18.0 million related to the amendment of Curis’s license agreement with Aurigene.

Revenues for the year ended December 31, 2017 were $9.9 million, as compared to $7.5 million for the same period in 2016. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2017 and 2016 were $3.3 million and $2.4 million, respectively.

Operating expenses were $59.7 million for the year ended December 31, 2017, as compared to $65.6 million for the same period in 2016. Operating expenses for the fourth quarter of 2017 were $10.4 million, as compared to $13.1 million for the same period in 2016, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the year ended December 31, 2017, as compared to $0.4 million for the same period in 2016. Cost of royalty revenues were $0.2 million for the fourth quarter of 2017, as compared to $0.1 million for the same period in 2016.

In-Process Research and Development Expense. The Company recorded a one-time in-process research and development expense of $18.0 million for the year ended December 31, 2016, related to the issuance of common stock to Aurigene. These shares were issued as consideration for the rights granted under the terms of the September 2016 amendment to the collaboration agreement.

Research and Development Expenses. Research and development expenses were $45.1 million for the year ended December 31, 2017, as compared to $31.6 million for the same period in 2016. The increase was primarily due to two payments to Aurigene for $3.8 million each, for an exclusivity option which were paid in January 2017 and September 2017 as well as increased costs related to ongoing clinical activities for CA-170. Employee-related expenses increased over the prior year period primarily due to higher stock based compensation and personnel costs. Research and development expenses were $6.9 million for the fourth quarter of 2017, as compared to $9.2 million for the same period in 2016.

General and Administrative Expenses. General and administrative expenses were $14.1 million for the year ended December 31, 2017, as compared to $15.6 million for the same period in 2016. The decrease in general and administrative expenses was driven primarily by lower legal, professional and consulting services and other administrative expenses, offset slightly by higher stock-based compensation for the period. General and administrative expenses were $3.3 million for the fourth quarter of 2017, as compared to $3.8 million for the same period in 2016.

Other expense, net was $3.6 million for the year ended December 31, 2017, as compared to $2.4 million for the same period in 2016. Other expense, net primarily consisted of interest expense related to the debt obligations of Curis Royalty (a wholly owned subsidiary of Curis). The increase in interest expense in the current year was related to a higher principal balance of Curis Royalty’s outstanding debt with HealthCare Royalty, which was refinanced in the first quarter of 2017. Other expense, net was $0.9 million for the fourth quarter of 2017, as compared to $0.6 million for the same period in 2016.

As of December 31, 2017, Curis’s cash, cash equivalents, marketable securities and investments totaled $60.2 million and there were approximately 164.2 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, CUDC-907:

In December 2017, investigators presented results from the combined analysis of the Phase 1 and Phase 2 trial results of CUDC-907 in patients with relapsed/refractory DLBLC, including those with MYC-altered disease, at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s annual meeting in Atlanta, Georgia.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

In December 2017, Curis scientists presented non-clinical results demonstrating significant anti-tumor activity when CA-4948 was combined with the BCL2 antagonist drug venetoclax, at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s annual meeting in Atlanta, Georgia.
In January 2018, Curis announced initiation of patient dosing in a Phase 1 trial of CA-4948 for treatment of patients with lymphoma. CA-4948 was discovered at Aurigene and is the second licensed program from the Curis-Aurigene collaboration to enter the clinic.
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene collaboration):

In November 2017, investigators presented preliminary results from the dose escalation stage of the Phase 1 trial of CA-170 in patients with advanced solid tumors or lymphomas, at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), in National Harbor, Maryland.
Curis collaborator, Aurigene, initiated patient enrollment of cancer patients in a Phase 2 clinical study of CA-170 at trial sites in India.
Immuno-oncology, CA-327 (PDL1 and TIM3 antagonist; Aurigene collaboration):

In November 2017, Curis scientists presented non-clinical results demonstrating CA-327’s ability to modulate tumor immune profile in mouse models, as well as its anti-cancer activity as a single agent or in combination with CA-170, at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), in National Harbor, Maryland.
Upcoming Activities

Curis expects that it will make presentations at the following conferences through April 2018:

Cowen & Company 38th Annual Health Care Conference (March 12-14) in Boston
Conference Call Information

Curis management will host a conference call today, March 8, 2018, at 8:30 a.m. EST, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial (877) 870-4263 from the United States or (412) 317-0790 from other locations, shortly before 8:30 a.m. EST. The conference call can also be accessed on the Curis website at www.curis.com in the Investors sectio

On March 8, 2018 INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported financial results for its fourth quarter and full year ended Dec. 31, 2017 (Press release, Insys Therapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337183 [SID1234524561]).

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OVERALL HIGHLIGHTS

Achieved gross revenue of $46.1 million, resulting in net revenue of $31.5 million.
Advanced product pipeline with total R&D investment of $16.4 million.
Completed pharmacokinetics (PK) study of naloxone nasal spray as investigational treatment of opioid overdose.
Completed FDA filing of NDA for buprenorphine sublingual spray as investigational treatment for moderate-to-severe acute pain.
Initiated Phase 2 clinical trial of cannabidiol (CBD) oral solution as investigational treatment for medically refractory childhood absence epilepsy.
Enrolled first patient in proof-of-concept study of epinephrine nasal spray as investigational treatment for anaphylaxis.
Received ‘Fast Track’ designation from FDA for CBD oral solution as investigational treatment for Prader-Willi syndrome.
Settled lawsuit with one major health insurer.
"Over the course of 2017, we implemented a series of significant changes that set the foundation for a new strategic direction for the company as a leader in pharmaceutical cannabinoids and spray technologies," said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. "This foundation was built around new leadership and elevated capabilities at all levels of the organization, which has allowed us to aggressively reposition and advance our product pipeline. Most importantly, this foundation establishes an unwavering commitment to enhance the quality of life for underserved patient populations, and we look forward to finding solutions for a number of orphan diseases through our R&D programs."

Motahari continued, "In the fourth quarter, we continued our efforts to stabilize SUBSYS despite the declining market for TIRF medications by securing several managed care wins that went into effect in January 2018. We also continued our controlled rollout of SYNDROS during the period. As a result, we intend to achieve top-line stability in 2018 in parallel with our ongoing transformation of the company."

Motahari concluded, "We believe our R&D in both pharmaceutical cannabinoids and spray technology platforms will propel INSYS to a strong market position for the coming years."

Financial & Operating Highlights

Net revenue for the fourth quarter of 2017 was $31.5 million, compared to $54.9 million for the fourth quarter of 2016.
Gross margin was 85.4 percent for the fourth quarter of 2017, compared to 82.1 percent in the same period of 2016.
Sales and marketing investment was $7.1 million for the fourth quarter of 2017, compared to $13.5 million for the fourth quarter of 2016.
Research and development investment increased to $16.4 million for the fourth quarter of 2017, compared to $15.5 million for the same period in 2016.
General and administrative expense increased to $19.7 million for the fourth quarter of 2017 from $15.8 million for the fourth quarter of 2016.
Income tax expense was $26.8 million for the fourth quarter of 2017 and included a $7.5 million charge related to the change in tax code and $22.6 million of expense to fully reserve our deferred tax assets, compared to an expense of $0.3 million during the fourth quarter of 2016.
Net loss for the fourth quarter of 2017 was $47.0 million, or ($0.65) per basic and diluted share, compared to a net loss of $3.7 million, or ($0.05) per basic and diluted share, for the fourth quarter of 2016.
Adjusted EBITDA loss for the fourth quarter of 2017 was $11.5 million, compared to Adjusted EBITDA of $6.1 million in the prior-year quarter. The reconciliation of net income to Adjusted EBITDA is included at the end of this news release.
The company had $163.9 million in cash, cash equivalents, and short-term and long-term investments with no debt as of Dec. 31, 2017.

Webcast Information

A conference call is scheduled for 5:00 p.m. Eastern Standard Time on March 8, 2018, to discuss the financial and operational results for the fourth quarter of and full year 2017. Interested parties can listen to the call live via the company’s website, View Source, on the INVESTORS section Presentations & Events page; or by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.). A webcasted replay of the call will be available on the site a few hours after the event.

on March 8, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that fourth quarter and year end 2017 financial results on Thursday, March 15, 2018. Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, March 15, 2018 to discuss the financial results and recent business developments (Press release, Genomic Health, MAR 8, 2018, View Source [SID1234524631]).

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To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 1181109. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company’s website, investors.karyopharm.com/events.cfm. An archived webcast will be available on the Company’s website approximately two hours after the event.

On March 8, 2018 Servier, Pfizer Inc. (NYSE: PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), reported that results from the two phase 1 trials with UCART19, the allogeneic anti-CD19 CAR T-cell product being developed by Servier and Pfizer, will be presented during the European society for Blood and Marrow Transplantation (EBMT) Annual Meeting to be held from March 18 to 21, 2018 in Lisbon, Portugal (Press release, Cellectis, MAR 8, 2018, View Source [SID1234524556]).

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Results from the CALM (UCART19 in Advanced Lymphoid Malignancies) study will be presented during an oral session by Reuben Benjamin, MD, PhD, Principal Investigator and consultant hematologist at King’s College Hospital, London, United Kingdom, on March 21, 2018 at 9:30 am (Room 5A). The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in adult patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

Presentation title: First-in-human study with UCART19, an allogeneic anti-CD19 car T-cell product, in high-risk adult patients with CD19+ R/R B-cell ALL: preliminary results of CALM study1

The PALL (Pediatric Acute Lymphoblastic Leukemia) study is a phase 1, open label, study to evaluate the safety and the ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory B-ALL. PALL was initiated in the UK in June 2016. Paul Veys, MD, PhD, Director of the Bone Marrow Transplant Unit at Great Ormond Street Hospital (GOSH), London, United Kingdom, will share data during an oral session on March 21, 2018 at 11:40 am (Auditorium IV).

Presentation title: Gene-edited allogeneic CAR19 T-cells (UCART19) induce molecular remission ahead of allo-sct in high risk pediatric patients with CD19+ relapsed/refractory B-cell Acute Lymphoblastic Leukemia2

Servier is the sponsor of both studies. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being codeveloped by Servier and Pfizer.

1 & 2 Abstracts are available on the EBMT website: View Source

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN. UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, "off-the-shelf" T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.

About Servier

Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4.152 billion euros in 2017, Servier employs 21,600 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs.

More information: www.servier.com

Pfizer Inc.: Working together for a healthier world

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

PFIZER DISCLOSURE NOTICE

The information contained in this release is as of March 7, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product candidate, UCART19, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when drug applications may be filed for UCART19 with regulatory authorities in any jurisdiction; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether UCART19 will be commercially successful; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of UCART19; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.