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.

On May 7, 2019 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported operating results for the first quarter ended March 31, 2019 and provided pipeline updates (Press release, AnaptysBio, MAY 7, 2019, View Source [SID1234535886]).

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"2019 is set to be an important year for AnaptysBio, with multiple top-line data readouts from our wholly-owned pipeline, initiation of a new Phase 2b trial of etokimab in eosinophilic asthma and submission of an IND for our next development candidate in our wholly-owned pipeline," said Hamza Suria, president and chief executive officer of AnapytsBio. "We look forward to advancing each of these programs as we work to bring novel treatments to patients with severe inflammatory diseases."

Etokimab (ANB020 Anti-IL-33 Program)

In September 2018, the Company reported positive interim top-line data from its Phase 2a proof-of-concept clinical trial of etokimab in adult patients with severe eosinophilic asthma. The Company will present the full data from this trial at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress. AnaptysBio also plans to initiate a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial of etokimab in eosinophilic asthma in 2019.

The Company is conducting a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adult patients with moderate-to-severe atopic dermatitis, also referred to as the ATLAS trial, to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab, with top-line data expected in the second half of 2019.

AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates top-line data from the ECLIPSE trial will be available in the second half of 2019.

ANB019 (Anti-IL-36 Receptor Program)

The Company is conducting a single arm, open-label Phase 2 trial of ANB019 in approximately 10 patients with generalized pustular psoriasis, or GPP, also known as the GALLOP trial, with top-line data expected in mid-2019.

The Company is conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top-line data anticipated in the first half of 2020.
First Quarter Financial Results

Cash, cash equivalents and investments totaled $484.2 million as of March 31, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $16.0 million. The decrease primarily relates to cash used for operating activities.

Research and development expenses were $20.6 million for the three months ended March 31, 2019, as compared to $11.8 million for the three months ended March 31, 2018. The increase was primarily due to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional

personnel-related expenses including share-based compensation during the three months ended March 31, 2019.

General and administrative expenses were $4.1 million for the three months ended March 31, 2019, as compared to $3.9 million for the three months ended March 31, 2018. The increase was primarily attributable to additional personnel-related expenses, including share-based compensation.

Net loss was $22.1 million for the three months ended March 31, 2019, or a net loss per share of $0.82, as compared to a net loss of $15.1 million for the three months ended March 31, 2018, or a net loss per share of $0.63.
Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
About Etokimab
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is conducting its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where top-line data is anticipated in the second half of 2019. The Company is conducting its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with top-line data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.
About ANB019
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP. AnaptysBio has previously presented data from this Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that supported advancement of ANB019 into Phase 2 studies. AnaptysBio is conducting its GALLOP trial, a Phase 2 study of ANB019 in GPP where top-line data is anticipated in mid-2019, and its POPLAR trial, a Phase 2 study in PPP where top-line data is anticipated in the first half of 2020.