Myovant Sciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Myovant Sciences, 2017, NOV 13, 2017, View Source [SID1234522024]).

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On November 13, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will present at the Jefferies 2017 London Healthcare Conference on Thursday, November 16, 2017 at 8:00 a.m. GMT at the Waldorf Hilton in London, UK (Press release, Karyopharm, NOV 13, 2017, View Source [SID1234521968]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On November 13, 2017 CohBar, Inc. (OTCQX: CWBR and TSXV: COB.U) ("CohBar" or the "Company"), an innovative biotechnology company focused on developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported financial results for the third quarter ended September 30, 2017 (Press release, CohBar, NOV 13, 2017, View Source [SID1234522000]).

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"The third quarter was significant for CohBar as we raised new capital, selected CB4211 for clinical studies, and designed a new Phase 1a/b clinical strategy to accelerate activity readouts," said Simon Allen, CohBar CEO. "By extending our phase 1 trial to include obese subjects with NAFLD, we can potentially accelerate activity readouts by more than a year compared to a standard phase 2 follow-on study. At the same time, several new peptides are demonstrating significant early stage potential for treating neurodegenerative diseases, Type 2 diabetes, and several cancer types, further evidencing the potential of the mitochondrial genome as a source of therapeutic peptides for a wide range of age-related diseases. We continue to focus on initiating our ‘first mitochondrial based therapeutic in human’ trial with CB4211 next year, while further optimizing and validating the potential of a number of our new peptides as possible clinical candidates."

Preclinical Developments and Business Highlights

● Expanded Lead Clinical Program. During the quarter, CohBar selected CB4211 as its lead clinical candidate for nonalcoholic steatohepatitis (NASH) and obesity, and continued to advance it through IND-enabling activities. More recently, the Company expanded its clinical plan with the addition of a phase 1b study to include obese subjects with NAFLD, in order to substantially accelerate activity readouts relevant to NASH and obesity.

● Presented Preclinical Data on CB4209 and CB4211 at AASLD Liver Meeting in October 2017. The Company presented previously undisclosed data from its lead candidate program in a poster entitled "CB4209 and CB4211 Reduce the NAFLD Activity Score in the STAM Model of NASH, Reduce Triglyceride Levels, and Induce Selective Fat Mass Loss in DIO Mice." CohBar scientists and their collaborators provided in vitro evidence that CB4209 and CB4211 regulate adipocyte lipolysis, a process that is foundational in the development of liver steatosis. The data corroborates previous in vivo evidence of anti-steatotic effects of the peptides on livers of mice on a high fat diet, where a corresponding reduction in circulating fat and biomarkers of liver damage was observed. The poster presentation can be viewed at www.cohbar.com.

● New CohBar Mitochondrial-Derived Peptides (MDPs). Using its proprietary technology platform, the Company identified a novel analog of a mitochondrial-derived peptide demonstrating early stage therapeutic potential for neurodegenerative diseases such as Alzheimer’s Disease, in addition to other recently identified MDPs showing therapeutic potential for Type 2 diabetes and cancer. These peptides are early stage analogs of previously unexplored natural peptides encoded within the mitochondrial genome which were identified by the Company’s mitochondrial genome mining activities. CohBar also filed provisional patent applications related to these natural peptides and their analogs.

● Mining the Mitochondrial Genome. The Company completed its comprehensive investigation of the mitochondrial genome, which identified previously unexplored peptides with therapeutic potential. To date, these discovery efforts have resulted in the identification of more than 100 new peptides, which are currently being evaluated for therapeutic potential, and prioritized for further development.

● Intellectual Property. The Company filed a PCT patent application covering its clinical candidate CB4211 as well as CB4209 and other analogs of MOTS-c with claims directed to both composition-of-matter and methods of use. To date, CohBar has filed more than 65 US and International patent applications.

● Pharma Partnering Activities. CohBar’s senior management together with advisor Torreya Partners continued to interact with major pharma companies as part of the Company’s expanded partnering program, including meetings with potential partners at the BIO Investor Forum in San Francisco in October, 2017.

● Investment Community Outreach. CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at the Rodman & Renshaw 19th Annual Global Investment Conference in New York in September, 2017.

● Completed $5.2 Million Private Placement. During the quarter the Company completed a private placement issuing 3,438,053 units at a price of $1.50 per unit for total proceeds of approximately $5.2 million. Each unit consisted of one share of the Company’s common stock and one common stock purchase warrant exercisable at $2.25 per warrant.

During the third quarter, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.

● Dr. Cohen delivered a lecture entitled "Nutrigenomics Meets the Mitochondria" at the 11th Congress of the International Society of Nutrigenetics and Nutrigenomics. He was also named one of PBS-Next Avenue’s Top 50 Influencers in Aging, and was elected to the USC Chapter of the National Academy of Inventors.

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● Dr. Barzilai was a featured presenter on the topic "Targeting Aging with Metformin (TAME)" at the 21st IAGG World Congress of Gerontology and Geriatrics. He was also a panelist at the AFAR 2017 Luncheon Awards’ "The Architects of Aging", a symposium in biotechnology and longevity, and a keynote speaker at the 4th Human Genetics Conference in New York. During the quarter, the NBC Today Show showcased Dr. Barzilai in a segment with correspondant Maria Shriver discussing the TAME (Targeting Aging with Metformin) Trial, and Dr. Barzilai’s TEDMED talk entitled "Can We Grow Older Without Growing Sicker" was released to the public.

Third Quarter 2017 Financial Highlights

● Cash and Investments. CohBar had cash and investments of $10,342,242 on September 30, 2017, compared to $8,686,420 on December 31, 2016.

● Note Payable. During the three months ended September 30, 2017, the Company paid $117,274 to the Alzheimers Drug Discovery Foundation as the final payment on its note payable. As of September 30, 2017, the Company had no debt on its balance sheet.

● R&D Expenses. Research and development expenses were $2,316,454 in the three months ended September 30, 2017 compared to $1,056,429 in the prior year quarter. The increase was due primarily to the costs related to our IND-enabling activities for advancing our lead drug candidates into clinical studies, an increase in stock-based compensation related to the fair value of new grants, and the revaluation performed at each balance sheet date of equity granted to consultants.

● G&A Expenses. General and administrative expenses were $549,505 in the three months ended September 30, 2017, compared to $598,507 in the prior year quarter. The decrease was primarily due to lower professional fees, since legal costs associated with our patents were capitalized, and we previously had a non-recurring recruiting fee in the prior year quarter.

● Net Loss. For the three months ended September 30, 2017, net loss was $2,861,107, or $0.07 per basic and diluted share, compared to a net loss of $1,653,729, or $0.05 per basic and diluted share, for the three months ended September 30, 2016.

Third Quarter Investor Call Information

Date: November 13, 2017
Time: 2:00 p.m. (Pacific Time)
Dial-in U.S. and Canada: 1-888-599-8667
Dial-in International: 1-719-325-2494
Conference ID# 6432383

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Slide Presentation – www.webex.com, click on the ‘Join’ button and enter Meeting Number 921656999 and Password Q3Call.

For individuals participating in the Investor Call and Slide Presentation, we request you please call into the audio and log into WebEx approximately 10 minutes before the start of the presentation so that we can begin promptly.

An audio recording of the call will be available beginning at 6:00 p.m. (Pacific Time) on November 13, 2017, through 9:00 p.m. (Pacific Time) on November 27, 2017. To access the recording please dial 1-844-512-2921 in the U.S. and Canada or 1-412-317-6671 internationally and reference Conference ID# 6432383.

The audio replay along with the slide presentation will also be available at www.cohbar.com beginning November 14, 2017 through November 27, 2017.

About CohBar’s Lead Program

CohBar’s lead preclinical development program is based on MOTS-c, a mitochondrial-derived peptide discovered in 2012 by the Company’s founders and their academic collaborators, whose research has shown that MOTS-c plays a significant role in the regulation of metabolism. The Company has developed novel, improved analogs of the MOTS-c peptide, CB4209 and CB4211, which have demonstrated significant therapeutic potential in preclinical models of obesity and nonalcoholic steatohepatitis (NASH).

On November 13, 2017 Novartis reported that it has had a strong year in innovation with several key approvals and positive trial readouts (Press release, Novartis, NOV 12, 2017, View Source [SID1234521950]). Novartis holds an R&D and investor update in London, which will provide deeper insights into key late-stage pipeline projects. In the Oncology business unit, Novartis is pursuing multiple indications for Kymriah, the first-in-class CAR-T therapy, and could further strengthen the oncology pipeline if the proposed acquisition of Advanced Accelerator Applications is closed. In the Pharmaceuticals business unit, Novartis continues to strengthen its position in Multiple Sclerosis through BAF312 (siponimod), OMB157 (ofatumumab) and the recent pediatric findings for Gilenya. During the investor event Novartis will provide a deep dive on the four selected programs below.

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In Ophthalmology, RTH258 (brolucizumab) data presented at the American Academy of Ophthalmology showed superiority versus aflibercept in key secondary endpoints reflective of disease activity in patients with nAMD. Patients treated with RTH258 showed fewer signs of specific disease activity than patients treated with aflibercept. RTH258 patients showed less retinal fluids, less fluid in the deepest part of the retina and superior reductions in retinal thickness. Novartis expects to file for the nAMD indication by Q4 2018 and expects to start clinical trials in DME and RVO during 2018. Additionally, RTH258 creates the potential opportunity for Novartis to enter the attractive growing US retina market.

In Neuroscience, AMG 334 (erenumab) is being developed to deliver an effective and safe prophylactic treatment for patients suffering from chronic or episodic migraine. This debilitating disease affects more than 10% of adults, mainly in their prime working years. AMG 334 has shown encouraging results in reducing monthly migraine days, even in difficult to treat patients. AMG 334 is a fully human, potent, selective CGRP antagonist targeting the receptor and it was the first CGRP antagonist to be filed in the US and EU, on track for a potential first-in-class launch in 2018.

In Immunology, Cosentyx continues to build on its best-in-class profile, which has demonstrated sustained control of signs and symptoms in PSO, PsA and AS. Cosentyx has strong differentiation based on its unique biology which has shown a high level of enthesitis resolution and no radiographic progression in psoriatic arthritis and ankylosing spondylitis. By targeting the IL-17A pathway, the cornerstone cytokine of enthesitis, Cosentyx has the potential to change the course of disease in AS and PsA. Cosentyx is uniquely positioned to continue growth in all indications, particularly in spondyloarthritis, where the segment opportunity is larger than psoriasis.

In Cardiology, ACZ885 (canakinumab) data showed there was a significant reduction in major adverse cardiac events, in a subpopulation of patients who achieved hsCRP<2mg/L three months after the initial treatment. This well defined target population is critical to establishing the product’s value proposition and commercial uptake. Feedback from FDA and EU regulators supports moving forward with regulatory submissions for cardiovascular risk reduction, which are planned for Q4 and onwards. The novelty of approach to reduce CV risk is recognized by the regulators and there is interest in understanding the relationship between hsCRP and patient response.

For background slides and webcast (audio only) please refer to the following link: View Source
The background slide decks will be available on Monday November 13th, 2017.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "pipeline," "on track," "moving forward," "will," "pursuing," "could," "continues," "expects," "by Q4 2018," "during 2018," "potential," "growing," "being developed," "encouraging," "launch," "to build," "positioned," "opportunity," "planned," "for Q4 and onwards," "interest in," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational and approved products described in this press release, including RTH258, AMG 334, ACZ885, BAF312, OMB157, Cosentyx, Kymriah and Gilenya, or regarding potential future revenues from such investigational and approved products, or by express or implied discussions regarding the potential outcome of the tender offer for Advanced Accelerator Applications, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Neither can there be any guarantee that the investigational or approved products described in this press release will be commercially successful in the future. Nor can there be any guarantee that the proposed acquisition described in this press release will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that Novartis will achieve any particular future financial results as a result of the proposed acquisition, or that Novartis will be able to realize any potential strategic benefits, synergies or opportunities as a result of the proposed acquisition. Nor can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Neither can there be any guarantee that the Group, or any of its divisions, will be commercially successful in the future, or achieve any particular credit rating or financial results. In particular, our expectations could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential acquisition described in this press release, as well as potential regulatory actions or delays with respect to the development of the products described in this press release; the potential that the strategic benefits, synergies or opportunities expected from the proposed acquisition may not be realized or may take longer to realize than expected; uncertainties regarding actual or potential legal proceedings, including, among others, potential legal proceedings with respect to the proposed acquisition; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures, such as from increased publicity on pharmaceuticals pricing, including in certain large markets; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; uncertainties regarding future demand for our products; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Additional Information
Novartis announced October 30, 2017, that it had entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA. The transaction is subject to certain closing conditions. Novartis will commence a tender offer upon completion of works council consultation and AAA’s Board of Directors recommending the tender offer to AAA shareholders. The senior management and Directors of AAA have, in their capacity as shareholders of AAA, undertaken to tender their shares into the proposed tender offer. The transaction is additionally subject to (i) the valid tender pursuant to the tender offer of ordinary shares (including ordinary shares in the form of American Depositary Shares) of AAA representing at least 80% of the outstanding ordinary shares on a fully diluted basis and (ii) receipt of customary transactional regulatory approvals and other customary closing conditions. Until such time as the closing conditions are satisfied, Lutathera remains under the custody and control of AAA. Novartis does not currently own or control these projects and will not have the ability to influence them until closing of the proposed acquisition of AAA which is subject to certain closing conditions and regulatory approvals.

Lutathera is a registered trademark of Advanced Accelerator Applications.

On November 13, 2017 argenx (Euronext & Nasdaq: ARGX) a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that management will present at several upcoming investor conferences in November (Press release, argenx, NOV 12, 2017, View Source;p=RssLanding&cat=news&id=2316341 [SID1234521948]):

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Stifel 2017 Healthcare Conference. Chief Scientific Officer, Hans de Haard, will present on Wednesday, November 15, 2017 at 2:45 p.m. ET in New York City.
Jefferies 2017 London Healthcare Conference. Chief Executive Officer, Tim Van Hauwermeiren, will present on Thursday, November 16, 2017 at 11:20 a.m. UTC in London.
Piper Jaffray 29th Annual Healthcare Conference. Chief Executive Officer, Tim Van Hauwermeiren, will present on Wednesday, November 29, 2017 at 2:30 p.m. ET in New York City.
Live webcasts of the presentations will be available on the Company’s website at www.argenx.com. Replays of the webcasts will be availalbe for 90 days following the presentation.