On May 7, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases and extend healthy lifespan, reported its financial results for the first quarter ended March 31, 2019 (Press release, CohBar, MAY 7, 2019, View Source [SID1234535945]).

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"The clear highlight since our last quarterly update was our announcement last week that we will be resuming the clinical trial of our lead therapeutic candidate, CB4211, for NASH and obesity," said Philippe Calais, CohBar’s interim CEO. "At the same time, we are expanding our evaluation efforts with novel analogs of mitochondrial encoded peptides targeting new potential indications, notably type 2 diabetes, cancer and fibrotic diseases. We continue to identify interactions between our novel analogs and new disease models, further validating our belief that mitochondria based therapeutics have significant potential to treat a broad range of age-related diseases with unmet medical needs."

First Quarter 2019 and Recent Clinical, Research and Business Highlights:

Upcoming Resumption of CB4211 Clinical Trial. The company recently announced that it will be resuming its Phase 1a/1b clinical trial of CB4211, its lead MBT candidate under development for the treatment of nonalcoholic steatohepatitis (NASH) and obesity. The company previously announced the suspension of the study in November 2018, to address mild but persistent injection site reactions.

New potential disease targets and mechanisms of action. During the first quarter and more recently, the company continued to advance its optimization and evaluation of novel analogs of mitochondrially encoded peptides with the identification of new disease targets and potential mechanisms of action. Recent studies have provided preliminary data on the evidence of antifibrotic activity of a novel peptide analog in in vitro and in vivo models of lung fibrosis, while another study demonstrated significant progress in exploring the potential for CohBar’s novel peptide analogs to enhance cancer cell killing in the setting of immuno-oncology.

Upcoming Presentation at American Diabetes Association, 79th Scientific Sessions. CohBar will present its recent discovery of the mechanism of action of a family of novel peptides with effects on glucose tolerance in animal models of type 2 diabetes. The mechanism involves interaction with a key cell surface receptor that plays an important role in a number of age-related diseases. We expect that the abstract title and session information will be available to the public on the ADA website on May 10, 2019.

Expansion of Board of Directors. David Greenwood joined the CohBar Board in April 2019. Mr. Greenwood brings to CohBar more than 40 years of financial and operational experience in biotechnology and investment banking. Mr. Greenwood served in leadership roles and on boards at both public and private biotechnology companies including Corium Inc. (formerly NASDAQ: CORI) and Geron Corporation.

Hosted Key Opinion Leader Call, "Mitochondria, a Source for Novel Therapeutics." The company hosted a Key Opinion Leader conference call and webcast on May 2, 2019, featuring world-leading experts and CohBar founders Dr. David Sinclair and Dr. Pinchas Cohen, and CohBar CSO Dr. Ken Cundy, discussing the role of mitochondria in health and aging and mitochondrial-derived peptides (MDPs) as a novel source of potential therapeutics for a host of major age-related diseases. A replay of the call is available on the homepage of the CohBar website, (www.cohbar.com).

Expanded IP Portfolio. The company’s IP portfolio recently expanded with the grant of a U.S. patent for its licensed asset MOTS-c. The company also converted its PCT application that describes CB4211 and its analogs into individual patent filings in the U.S. and in multiple international jurisdictions. The applications claim CB4211 composition of matter and methods for using it for the treatment of various diseases.

Continued Investment Community Outreach. In addition to meetings and presentations earlier in the quarter at the JP Morgan Healthcare Conference and at the BIO Investor Forum, company management met with investors at the Roth Conference in March, where interim CEO Philippe Calais also participated in a panel entitled "Why Knowing NASH as a Generalist Can Make You Rich in 2019."
During the first 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 delivered a presentation entitled "Novel Aspects of Mitochondrial Biology and its Implications for Healthy Aging" at the International Conference on Frailty and Sarcopenia Research in Miami Beach, Florida, in February 2019. More recently, in April, Dr. Cohen co-authored an article published in Mitochondrion entitled "Effects of air pollution on mitochondrial function, mitochondrial DNA methylation, and mitochondrial peptide expression."

Dr. Barzilai delivered keynote lectures at Unfolding Aging, in March 2019, in Berlin, Germany, and at the National Medical Research Council, in April 2019, in Singapore. He also lectured about diabetes and aging at the National Medical Research Council, in April 2019, in Singapore, and at the Wellness Summit in March 2019, at Rockefeller University in New York; and delivered the Raining Grant Annual Lectureship at the University of Minnesota in April 2019. During the quarter, Dr. Barzilai co-authored 3 published papers including "Interrogating the Genetic Determinants of Tourette’s Syndrome and Other Tic Disorders Through Genome-Wide Association Studies," in The American Journal of Psychiatry, "APOE Alleles and Extreme Human Longevity," in the Journal of Gerontology, and "Models and Studies of Aging: Executive Summary of a Report from the U13 Conference Series," in The Journal of American Geriatrics.
First Quarter 2019 Financial Highlights

Cash and Investments. CohBar had cash and investments of $19,531,260 on March 31, 2019, compared to $22,182,768 on December 31, 2018.

R&D Expenses. Research and development expenses were $1,371,848 in the three months ended March 31, 2019, compared to $2,680,983 in the prior year quarter. The decrease was primarily due to the timing of certain preclinical and clinical costs incurred in the prior year period, and lower stock-based compensation costs, partially offset by an increase in costs associated with our research programs focused on the continuing development of peptides.

G&A Expenses. General and administrative expenses were $1,456,197 for the three months ended March 31, 2019, compared to $913,088 in the prior year quarter. The increase in general and administrative expenses was primarily due to stock-based compensation costs, recruiting costs, and increased director fees.

Net Loss. For the three months ended March 31, 2019, net loss was $2,920,584, or $0.07 per basic and diluted share, compared to a net loss of $3,586,585, or $0.09 per basic and diluted share, for the three months ended March 31, 2018.
First Quarter Investor Call and Slide Presentation:

Date: May 7, 2019
Time: 5:00 p.m. EDT (2:00 p.m. PDT)

Conference Audio

Dial-in U.S. and Canada: (800) 289-0438
Dial-in International: (323) 794-2423
Conference ID No.: 1071020
Slide Presentation

Go to www.webex.com, click on the ‘Join’ button and enter meeting number 924 256 010 and Password CWBR, or
Go to www.cohbar.com and click on Q1 2019 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. EDT on May 7, 2019, through 11:59 p.m. EDT on May 28, 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# 1071020. The audio replay along with the slide presentation will also be available on the homepage at www.cohbar.com from May 7, 2019 through May 28, 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 but persistent injection site reactions, and announced the anticipated resumption of the clinical trial in May 2019. 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 May 7, 2019 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported financial results for the first quarter ended March 31, 2019 (Press release, Principia Biopharma, MAY 7, 2019, View Source [SID1234535891]).

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"In 2019, we are focused on executing our value-creating clinical development initiatives, including enrollment of our global Phase 3 trial in patients with pemphigus, the release of top-line PRN1008 data from a Phase 2 clinical trial in immune thrombocytopenia (ITP) and a Phase 2 extension trial in pemphigus vulgaris," said Martin Babler, president and chief executive officer of Principia. "We started this year with a presentation of our Phase 2 clinical trial, the Believe-PV study, for PRN1008 as part of the Late-breaking Research: Clinical Trials program at the American Academy of Dermatology (AAD) annual meeting in Washington D.C. In addition, we have appointed industry veteran Shao-Lee Lin to our Board of Directors and have reacquired the rights to our oral immunoproteasome program from AbbVie."

First Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $163.6 million as of March 31, 2019, compared to $30.0 million as of March 31, 2018. The increase in Principia’s cash position is mainly due to net proceeds of $113.6 million from its IPO in September 2018 and net proceeds of $49.8 million from its Series C financing.

Revenues: Collaboration revenue was $5.2 million for the three months ended March 31, 2019, compared to $11.5 million for the same period in 2018. The decrease was due to the upfront payment of $40.0 million received in December 2017 from Sanofi, which was fully recognized as of December 31, 2018.

R&D Expenses: Total research and development expenses were $15.5 million for the three months ended March 31, 2019, including stock-based compensation expense of $1.2 million, compared to $8.8 million for the same period in 2018, including stock-based compensation expense of $0.2 million. The increase in total research and development expenses was mainly driven by an increase in employee-related expenses as we build out our R&D team, and an increase in PRN1008 program costs, due to the initiation of a global Phase 3 trial in patients with pemphigus in November 2018 and the initiation of a Phase 2 clinical trial in patients with immune thrombocytopenia in December 2017.

G&A Expenses: General and administrative expenses were $4.5 million for the three months ended March 31, 2019, including stock-based compensation expense of $1.1 million, compared to $2.2 million for the same period in 2018, including stock-based compensation expense of $0.2 million. The increase in total general and administrative expenses was primarily driven by increased employee-related expenses and increased headcount costs. The increased employee-related expenses were attributable to increased stock-based compensation expenses due to a higher valuation of options granted during the three months ended March 31, 2019.

Net Income (Loss): For the three months ended March 31, 2019, net loss was $13.7 million compared to a net income of $0.3 million for the same period in 2018.

On May 7, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) reported its financial and operating results for the first quarter ended March 31, 2019 (Press release, AEterna Zentaris, MAY 7, 2019, View Source [SID1234535890]).

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All Amounts are in U.S. Dollars

Highlights

In March 2019, the Board formed a Special Committee to review strategic options available to the Company and engaged Torreya Partners to assist in that process
In January 2019, European Medicines Agency granted marketing authorization for macimorelin for diagnosis of adult growth hormone deficiency
Net loss for the first quarter of 2019 $4.9 million, compared to net income of $14.4 million for the same period in 2018
As of March 31, 2019, we had $11.4 million of unrestricted cash and cash equivalents
Summary of First Quarter Results

For the three-month period ended March 31, 2019, we reported a consolidated net loss of $4.9 million, or $0.30 loss per common share, as compared with a consolidated net income of $14.4 million, or $0.88 income per common share, for the three-month period ended March 31, 2018. The $19.3 million decline in net loss results primarily from a reduction of $24.6 million in total revenues and $3.9 million increase in net finance loss, offset by a reduction of tax expense of $6.9 million and of operating expenses of $2.3 million. In January 2018, the Company received a $24.0 million cash payment under a license and assignment agreement for Macrilen (macimorelin).

Condensed Interim Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the condensed interim consolidated financial statements as at March 31, 2019 and for the three-month periods ending March 31, 2019 and 2018 and management’s discussion and analysis of financial condition and results of operations for the first quarter ended March 31, 2019, will be found at www.zentaris.com in the "Investors" section and at the Company’s profile at www.sedar.com and www.sec.gov.

The following tables set out summary consolidated financial information for the periods indicated. The results of operations for interim periods are not necessarily indicative of the results to be expected for a full year or any future period. The information presented herein does not contain disclosures required by IFRS for consolidated financial statements and should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2018.

On May 7, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in personalized medicine, reported financial results for its fiscal third-quarter 2019, provided an update on recent business highlights, updated its fiscal year 2019 financial guidance, and provided fiscal fourth-quarter 2019 financial guidance (Press release, Myriad Genetics, MAY 7, 2019, View Source [SID1234535889]).

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"During the fiscal third-quarter we once again saw meaningful year-over-year growth in our hereditary cancer business, continued strong volume trends with our prenatal and GeneSight tests and posted one of the most profitable quarters in the history of the company," said Mark C. Capone, president and CEO, Myriad Genetics. "We continue to advance our diversification efforts with new products representing more than 76 percent of overall volume. With ongoing volume growth and expanding reimbursement, we remain highly optimistic about our future growth prospects."

Business Highlights

Hereditary Cancer

Year-over-year revenue growth reached four percent, the highest in the last five fiscal years.

Achieved ninth consecutive quarter of year-over-year hereditary cancer testing volume growth and sixth consecutive quarter with stable hereditary cancer pricing.

The American Society of Breast Surgeons expanded hereditary cancer testing guidelines to all breast cancer patients.

Data presented at the American College of Obstetrics and Gynecology meeting from a

large clinical study showed that 23 percent of women met National Comprehensive Cancer Network Guidelines for hereditary cancer screening, substantially higher than previously estimated.

GeneSight

Test volume increased 19 percent year over year.

Signed agreement with Kroger Prescription Plans to cover GeneSight as a medical benefit for Kroger Prescription Plans employer group clients and to launch a pharmacy medical management intervention in Kroger stores.

Prenatal Testing

Test volume grew seven percent sequentially following the integration of the Counsyl and Myriad women’s health sales teams.

Announced in-network agreement with UnitedHealthcare effective April 1, 2019.

Launched expanded aneuploidy screening for Prequel non-invasive prenatal screening test for all 23 chromosome pairs increasing sensitivity by 30 percent.

Presented data at the American College of Medical Genetics meeting from a 58,000 patient study demonstrating that the Prequel test was highly accurate below a four percent fetal fraction cutoff and that the inclusion of a cutoff did not improve test accuracy.

Published an expanded carrier screening study in Genetics in Medicine, demonstrating that 38 genes in the Foresight test met all panel inclusion criteria commonly recommended in medical guidelines.

Prolaris

Fiscal third-quarter revenue increased eight percent year-over-year to $6.9 million.

Received positive medical policy decisions from Blue Cross Blue Shield of Kansas, SmartHealth, Blue Cross Blue Shield of Northeastern New York, and Blue Cross Blue Shield of Western New York, thereby increasing coverage to 27 million commercial lives in the United States.

EndoPredict

Fiscal third-quarter revenue increased 22 percent year-over-year to $2.8 million.

New publication in Breast Cancer Research and Treatment found that the EndoPredict test accurately predicts the magnitude of chemotherapy benefit in women with ER-positive, HER2-negative breast cancer.

Companion Diagnostics

Submitted the first module of premarket approval application (PMA) for myChoice HRD CDx as a companion diagnostic for GlaxoSmithKline’s PARP inhibitor, niraparib, in ovarian cancer patients.

Announced new data showing BRACAnalysis CDx successfully identified patients with pancreatic cancer who benefitted from olaparib in AstraZeneca’s POLO study. Myriad intends to file a supplementary PMA to the U.S. Food and Drug Administration for BRACAnalysis CDx as a companion diagnostic for olaparib in patients with pancreatic cancer.

Expanded research collaboration with Merck and AstraZeneca to provide BRACAnalysis CDx testing for patients with metastatic castrate resistant prostate cancer.

Received approval from the Japanese Ministry of Health Labour and Welfare for BRACAnalysis CDx as a companion diagnostic for olaparib in first-line ovarian cancer patients.

myPath Melanoma

Received positive final local coverage decision from Noridian Healthcare Solutions for myPath Melanoma.

Fiscal Year 2019 and Fiscal Fourth-Quarter 2019 Financial Guidance

Below is a table summarizing Myriad’s fiscal year 2019 and fiscal fourth-quarter 2019 financial guidance:

Myriad’s fiscal year 2019 and fourth-quarter 2019 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today and discuss the fiscal second-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, May 7, 2019, at 4:30 p.m. EDT to discuss

Myriad’s financial results for the fiscal third-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-908-1487. International callers may dial 1-303-223-0120. All callers will be asked to reference reservation number 21920022. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On May 7, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported that it will present a poster on the performance of its lead investigational drug, lasofoxifene, at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sermonix Pharmaceuticals, MAY 7, 2019, View Source [SID1234535888]). The abstract, "Lasofoxifene as a Potential Treatment for ER+ Metastatic Breast Cancer," will be presented during the poster session Breast Cancer – Metastatic, June 2, 8-11 a.m., at McCormick Place in Chicago.

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Sermonix is currently enrolling patients in the Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study, assessing the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation.

"For the abstract presented at ASCO (Free ASCO Whitepaper) 2019, we used a mouse intraductal model to investigate the combination of lasofoxifene and palbociclib, a CDK4/6 inhibitor, as a potential therapeutic for mutant ESR1 metastatic breast cancer, as compared to palbociclib and fulvestrant," said Barry Komm, Sermonix chief scientific officer. "We look forward to sharing our findings at this important gathering of the oncology community."

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized SERM, lasofoxifene, if approved, could play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.