On March 18, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported its financial results for the fourth quarter ended December 31, 2018 (Press release, CohBar, MAR 18, 2019, View Source [SID1234534465]).

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"We continue to focus on getting CB4211 back into the clinic as soon as possible, and have engaged in direct discussions this month with the FDA about our revised clinical plan," said Philippe Calais, CohBar’s interim chief executive officer. "At the same time, our increased investment in research is enabling significant progress in evaluating our new peptides in an expanded range of disease models, and uncovering mechanisms that open new potential opportunities for additional therapeutic targets. We also continue to make progress optimizing novel peptides as potential therapeutics for type 2 diabetes and cancer. These developments on multiple fronts reinforce our belief in the therapeutic potential of our portfolio of mitochondrial peptides to treat multiple age-related diseases."

Fourth Quarter 2018 and Recent Clinical, Research and Business Highlights:

CB4211 Clinical Study Update. The company retained Dr. James Leyden, Professor Emeritus of Dermatology at University of Pennsylvania, a well-respected expert and advisor to U.S. and European regulatory agencies, who reviewed the clinical data related to the mild but persistent indurations observed in the company’s temporarily-suspended Phase 1a/1b clinical trial. Dr. Leyden reported his conclusions that there were no significant safety issues and participated in the company’s call with the FDA in early March. The company is submitting additional information to the FDA, with the goal of resuming clinical activities as soon as possible.

CohBar Pipeline Update. During the fourth quarter and more recently, the company continued to advance its optimization and evaluation of novel analogs of its previously discovered peptides, and the identification of potential mechanisms and disease targets. In the area of type 2 diabetes research, the company recently discovered the interaction between a family of novel peptide analogs with effects on glucose tolerance in animals and a key cell surface receptor. This receptor plays an important role in a number of age-related diseases. CohBar submitted an abstract on this discovery for presentation at a major scientific meeting scheduled for later this year.

Appointed Dr. Philippe Calais as Interim CEO. Dr. Calais became interim CEO in December, bringing to the company more than 30 years of large and small-cap biopharmaceutical experience in product development and commercialization, partnerships, collaborations and financings. He most recently served as Chief Executive Officer of Isarna Therapeutics B.V., after having led several clinical stage biopharmaceutical companies in Canada and in Europe, and Univalor LTD, a large technology transfer organization in Canada. Earlier in his career, he served in multiple roles at F. Hoffmann-La Roche.

Expanded the Company’s Board of Directors. Dr. Phyllis Gardner joined the CohBar Board in February 2019, adding broad and deep expertise in academia, medicine, pharmacology, drug delivery, biotechnology and corporate investing and governance to the CohBar board. Dr. Gardner’s background includes roles as a senior scientist at ALZA Corporation, a partner at Essex Woodland Health Ventures and over 30 years as a distinguished professor of medicine at Stanford University School of Medicine.

Investment Community Outreach. During the fourth quarter, CohBar presented an overview of the company and its clinical development program at The BIO Investor Forum. The company also met with investors, bankers and analysts during the JP Morgan Healthcare conference in January 2019, and presented at the BIO CEO and Investor Conference in February. At BIO CEO, Dr. Calais was featured on a panel entitled "Attacking Biological Mechanisms of Aging to Extend Healthspan."

Media Coverage. An article entitled "CohBar Develops Targeted Mitochondria Based Therapeutics for Metabolic Disorders that Cause Age-Related Diseases," and an interview with Dr. Calais, were published in the February 15, 2019 issue of Beikoku Seiyaku Gyokai Shuho. Beikoku Seiyaku Gyokai Shuho is a weekly report covering the U.S. pharmaceutical market. Its subscribers include some of Japan’s largest pharmaceutical and other life sciences companies.
During the fourth quarter and more recently, 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 was featured as a keynote speaker at "The Barshop Symposium on Exercise Regulation of Biological Aging" in San Antonio, Texas and at "The Gerontological Society of America" in Boston, Massachusetts. Dr. Cohen also co-authored three studies related to mitochondrial peptides published during the quarter and recently: "Characterizing the Protective Effects of SHLP-2, a Mitochondrial Derived Peptide, in Macular Degeneration," in Nature Scientific Reports (October 2018), "Humanin is a Novel Regulator of Hedgehog Signaling and prevents Glucocorticord-induced Bone Growth Impairment," in FASEB Journal (January 2019), and "MOTS-c, an Equal Opportunity Insulin Sensitizer," Journal of Molecular Medicine (February 2019).

Dr. Barzilai was awarded the prestigious international Fondation IPSEN Longevity Prize during the 22nd Geriatric Society of America meeting held on November 17, 2018 in Boston, Massachusetts. Dr. Barzilai also delivered keynote lectures at the "Happy Aging Day," in Brussels, Belgium, "The Cristofalo Annual Lectureship," at The University of Pennsylvania, "Endokrinologisches Symposium," in Berlin, Germany, "The Longevity Therapeutics Summit," in San Francisco, California, "The Science and Business of Aging," Boston, Massachusetts, and "The Taft Lectureship at the Nutrition Center," also in Boston, Massachusetts. Dr. Barzilai also authored four published articles: "Effects of FOXO3 Polymorphisms on Survival to Extreme Longevity in Four Centenarian Studies," in The Journals of Gerontology, "Sarcosine is Uniquely Modulated by Aging and Dietary Restriction in Rodents and Humans," in Cell Reports, "PopCluster: an Algorithm to Identify Genetic Variants with Ethnicity-dependent Effects," in Bioinformatics, and "Models and Studies of Aging: Executive Summary of a Report from the U13 Conference Series," in the Journal of American Geriatrics Society.
Fourth Quarter 2018 Financial Highlights

Cash and Investments. CohBar had cash and investments of $22,182,768 on December 31, 2018, compared to $8,452,459 on December 31, 2017.

R&D Expenses. Research and development expenses were $2,085,662 in the three months ended December 31, 2018, compared to $1,791,212 in the prior year quarter. The increase was primarily due to the transition of our lead MBT Candidate from preclinical to clinical stage, resulting in an increase in clinical activity costs incurred in the current year quarter partially offset by a decrease in preclinical activity costs incurred in the prior year quarter.

G&A Expenses. General and administrative expenses were $2,009,604 for the three months ended December 31, 2018, compared to $1,059,565 in the prior year quarter. The increase in general and administrative expenses was primarily due to severance and non-cash stock-based compensation costs related to the termination of our former CEO, recruiting costs, and increased director fees.

Net Loss. For the three months ended December 31, 2018, net loss was $4,190,125, or $0.10 per basic and diluted share, compared to a net loss of $2,833,396, or $0.07 per basic and diluted share, for the three months ended December 31, 2017.
Fourth Quarter Investor Call and Slide Presentation:

Date: March 18, 2019
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (800) 289-0438
Dial-in International: (323) 794-2423
Conference ID No.: 8144256
Slide Presentation

Go to www.webex.com, click on the ‘Join’ button and enter Meeting Number 923 629 679 and Password CWBR, or
Go to www.cohbar.com and click on Q4 Shareholder Presentation at top of homepage.
We kindly request that you please call into the conference audio and log into WebEx approximately 10 minutes prior to the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 18, 2019, through 11:59 p.m. Eastern Time on April 8, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 8144256. The audio replay along with the slide presentation will also be available on the homepage at www.cohbar.com from March 18, 2019 through April 8, 2019.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

On March 18, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported at R&D Day in New York the continued progress of the its pipeline of proprietary CAR-T therapies for the treatment of hematological malignancies and solid tumors, based on its short hairpin RNA (shRNA) platform (Press release, Celyad, MAR 18, 2019, View Source [SID1234534464]).

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"We are very pleased with the recent progress of our preclinical CAR-T pipeline," noted Dr. Christian Homsy, CEO of Celyad. "Together with CYAD-101, our next generation allogenic shRNA platform should allow us to leapfrog the competition in the allogeneic CAR-T landscape. In addition, CYAD-02 has shown encouraging preclinical data of increased CAR-T cell expansion, persistence and anti-tumor efficacy. We continue to tap into our deep expertise and knowledge in cell therapy manufacturing and our all-in-one vector approach provides tremendous flexibility, versatility and efficiency in the design of novel, CAR-T therapies."

Corporate Updates

Lead asset CYAD-01 continues to advance in clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML). The Company reported that additional dosing and schedule optimization are under evaluation in the THINK Phase 1 trial. In addition, the Company reported that interim data from the DEPLETHINK Phase 1 trial evaluating CYAD-01 following preconditioning chemotherapy shows the CAR-T cell therapy is well-tolerated at the initial dose levels following preconditioning chemotherapy. Future clinical updates from the Phase 1 THINK and DEPLETHINK trials are anticipated by mid-2019.
Company also highlighted its operational excellence for 2018 including a 94% manufacturing success rate and a twofold increase year-over-year in the number of patients treated.
shRNA Platform

In October 2018, Celyad announced it had entered into an exclusive agreement with Horizon Discovery Group for the use of its shRNA technology to generate a novel, next-generation, non-gene-edited allogeneic platform for CAR-T therapies. Horizon Discovery’s SMARTvector technology to express shRNA optimized by Celyad provides an alternate method to knockout the TCR complex in allogeneic CAR-T therapies compared to gene editing techniques as well as the specificity to target a broad range of proteins.
Utilization of the shRNA platform allowed the Company to develop the next generation of autologous, NKG2D-based CAR-T candidate, CYAD-02, and the novel, non-gene edited allogeneic CYAD-200 series of CAR-T candidates.
In addition, the shRNA platform complements the Company’s strong intellectual property of six U.S. patents related to allogeneic T-cell technology and producing TCR deficient cells expressing a CAR construct.
Autologous CAR-T candidate: CYAD-02

CYAD-02 incorporates shRNA technology to target NKG2D ligands MICA/MICB. In preclinical AML models, CYAD-02 shows an encouraging increase in in vitro proliferation and in vivo persistence and anti-tumor activity. The Company plans to generate additional preclinical proof-of-concept data for the program throughout 2019 and plans to submit an Investigational New Drug (IND) application for CYAD-02 in first half 2020.
Non-gene edited allogeneic CAR-T candidates: CYAD-200 series

Celyad utilizes two technologies based on non-gene edited approaches to modulate the T-cell receptor (TCR) complex to generate allogeneic CAR-T therapies. The first approach utilizes our TCR-inhibitor molecule (TIM) and is tailored to our NKG2D-based CAR-T clinical candidate CYAD-101. The second approach leverages shRNA technology exclusively licensed from Horizon Discovery to target the CD3ζ component to knockdown the expression of the TCR/CD3 complex on the surface of the T-cell.
In vivo data demonstrate that shRNA targeting of CD3ζ effectively protects against Graft-versus-Host Disease (GvHD) to a level equivalent to CRISPR-Cas9 based knock-out. Furthermore, results from preclinical tests show significant increase in persistence of allogeneic T cells using shRNA targeting when compared to gene editing technologies, such as CRISPR-Cas9.
Celyad announced plans to develop three disruptive first-in-class non-gene-edited allogenic CAR-T candidates leveraging the shRNA SMARTvector platform, including:
CYAD-211: B-cell maturation antigen (BCMA) targeting CAR-T therapy for the treatment of multiple myeloma, which is expected to enter the clinic by mid-2020.
CYAD-221: CD19 targeting CAR-T therapy for the treatment of B-cell malignancies, which is expected to enter the clinic by late 2020.
CYAD-231: Dual specific CAR-T targeting NKG2D and an undisclosed membrane protein, which is expected to enter the clinic by early 2021.
In addition, the company continues to investigate additional undisclosed targets using the shRNA platform to pair with CARs to develop, differentiated next-generation cell therapies for the treatment of both hematological malignancies and solid tumors.

On March 18, 2019 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the Oppenheimer & Co. 29th Annual Healthcare Conference on March 20th, 2019 at 2:45pm Eastern Time at the Westin New York Grand Central in the Track 2 Room in New York, NY (Press release, BioTime, MAR 18, 2019, View Source;p=RssLanding&cat=news&id=2391558 [SID1234534463]).

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Interested parties can access a live audio webcast on the Events and Presentations section of BioTime’s website and an archived presentation will be available for 30 days. Interested parties may follow @OppenheimerCo on Twitter and use #OPCOHealthcare for the latest conference updates.

On March 18, 2019 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on gastrointestinal (GI) diseases, reported that Mr. Adi Frish, senior vice president of business development and licensing, will present a corporate overview at the BIO-Europe Spring 2019 conference on Wednesday, March 27, 2019, at 9:45 a.m. CET at the Messe Wien Exhibition and Congress Center in Vienna, Austria (Press release, RedHill Biopharma, MAR 18, 2019, View Source [SID1234534462]).

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A copy of the presentation to be delivered by Mr. Frish will be available on the Company’s website and may be viewed at: View Source

On March 18, 2019 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Lpath, MAR 18, 2019, View Source [SID1234534460]).

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Highlights
•Fourth quarter ESS revenue contributed 64% of continuing product sales and increased 46%
•ESS revenue for the full year 2018 of $23.4 million increased 42% compared to 2017
•Sale of the Surgical product line completed on December 17, 2018
•New credit facility with Solar Capital completed March 15, 2019

Todd Newton, CEO of Apollo, said, "With the sale of the Surgical product line in December, moving forward we are able to direct our attention exclusively on the growth opportunities of our Endo-bariatric product line. Demand for OverStitch was strong in the fourth quarter as the treatments possible with this unique technology continue to gain physician adoption and as of the beginning of February we are into the full launch of the new single channel compatible OverStitch Sx in the United States and Europe."

Apollo reported Endo-bariatric product revenues of $10.8 million in the fourth quarter of 2018, an increase of 10%. Fourth quarter total revenues which included sales of the divested Surgical product line, were $15.2 million a decrease of 6%. For the year, Endo-bariatric product revenues were $41.1 million, an increase of 15%. Total revenue for the year which includes sales of the divested Surgical products were $60.9 million, a decrease of 5%.

Fourth quarter Endoscopic Suturing System ("ESS") product sales increased 46% to $6.9 million from increases in product utilization in existing accounts and new user adoption. For the year, ESS product sales were $23.4 million, an increase of 42%.

Fourth quarter Intragastric Balloon ("IGB") product sales were $3.9 million, a decrease of 23%. U.S. IGB sales declined 20% due to ongoing market weakness due to negative media impressions following prior FDA communications. OUS IGB product sales decreased 24%, due primarily to lower sales in Brazil and our distributor markets which offset higher sales of Orbera365 in our direct European markets. For the year, IGB product sales were $17.7 million, a decrease of 9%.

Gross margin for the fourth quarter of 2018 was 46.6%, compared to 57.7% for the fourth quarter of 2017 primarily due to a greater proportion of our product sales coming from our ESS products, which realize a lower gross margin than our other products. During the fourth quarter of 2018 we completed two gross margin improvement projects related to both the ESS and IGB products which we expect on a combined basis to improve gross margin by approximately $2 million annually beginning in 2019. Gross margin for the year was 54.5% compared to 61.8% in 2017.

Total operating expenses were $23.9 million in the fourth quarter of 2018 and included a loss on the sale of our Surgical product line of $7.8 million. Excluding this one-time item, operating expenses were $16.2 million in the fourth quarter of 2018, an increase of 6%. Research and development costs increased as a result of expanded clinical study activities related to our Endo-bariatric products, new product development activities, and margin improvement projects. Excluding the loss on sale of the Surgical product line, operating expenses for the year were $65.5 million compared to $62.2 million, an increase of 6% due to higher research and development expenses.

Net loss for the fourth quarter 2018 was $18.4 million compared to $7.3 million for the fourth quarter 2017. For the year, net loss was $45.8 million in 2018 compared to $27.3 million in 2017.

Cash, cash equivalents and restricted cash were $25.0 million as of December 31, 2018.

Debt Financing

On March 15, 2019, we entered into a new credit facility with Solar Capital to borrow $35.0 million. The new facility may provide an additional $15.0 million upon our request, subject to further credit approval. We used $22.4 million of these proceeds to pay off the remainder of our prior credit facility. Interest on borrowings under the new credit facility is payable at

LIBOR plus 7.5% (currently 10.0%). Principal payments will begin after a 24-month interest only period payable on a straight-line basis until maturity on September 1, 2023.

Conference Call

Apollo will host a conference call on Monday, March 18, 2019 at 7:30 a.m. Central Time / 8:30 a.m. Eastern Time to discuss Apollo’s operating results for the fourth quarter and year ended December 31, 2018.

To participate in the conference call dial (877) 823-8673 for domestic callers and (647) 689-4156 for international callers. The conference ID number is 3671589. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.

A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, following the call. In addition, a transcript of the earnings call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.