On February 28, 2019 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, March 7, 2019 to report its fourth quarter and full year 2018 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, FEB 28, 2019, View Source [SID1234533833]).

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To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international) and refer to conference ID 7258556. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On February 28, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY) a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported financial results and a corporate update for the quarter and year ended December 31, 2018 (Press release, CymaBay Therapeutics, FEB 28, 2019, View Source [SID1234533857]).

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"The initiation of ENHANCE, our global, Phase 3 registration study of seladelpar in primary biliary cholangitis (PBC) at the end of 2018 was a major milestone for CymaBay," said Sujal Shah, President and CEO of CymaBay. "ENHANCE was initiated on the strength of what we believe to be a very compelling and differentiated profile in Phase 2, which highlighted the potential for seladelpar to offer patients with PBC improved efficacy and better tolerability than existing second line treatment. Seladelpar has now been granted Breakthrough Therapy Designation for PBC by the FDA and PRIority MEdicine status by the EMA. In parallel, we are advancing clinical development of seladelpar in nonalcoholic steatohepatitis (NASH) and were excited earlier this month to announce the completion of enrollment in our Phase 2b study, one quarter ahead of schedule. Seladelpar is the only highly selective and potent PPARδ agonist in development for liver disease, and we believe it may be particularly well suited to treat NASH. The ability of seladelpar to lower bile acids, cholesterol and lipotoxic lipids, coupled with anti-inflammatory and anti-fibrotic actions may position it as a foundational therapy for NASH."

Recent Business Highlights

In February 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage PBC in combination with ursodeoxycholic acid (UDCA) in adult patients with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
In February 2019, enrollment was completed in a Phase 2b dose-ranging, paired liver biopsy study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH).
A total of 181 patients enrolled with elevated liver fat and biopsy-confirmed NASH.
Topline data on the primary efficacy outcome, the change from baseline in liver fat content at 12 weeks as measured by magnetic resonance imaging using the proton density fat fraction method (MRI-PDFF), are expected 2Q 2019.
Fourth Quarter 2018 Highlights

Initiated ENHANCE, a global, Phase 3 registration study of seladelpar for the treatment of primary biliary cholangitis (PBC).
ENHANCE is being conducted in more than 150 centers in over 20 countries. The study is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval.
The study is expected to be fully enrolled by the end of 2019 with the 52-week treatment period targeted to be completed by the end of 2020.
Positive data from an ongoing Phase 2 study of seladelpar in PBC were featured at late-breaking presentations during The Liver Meeting 2018 hosted by the American Association for the Study of Liver Diseases.
Sustained anti-cholestatic and anti-inflammatory effects observed with no worsening of pruritus through 52 weeks.
Results highlight the potential for seladelpar to offer patients an efficacious and safe second line treatment option.
Results suggest that seladelpar is not associated with drug-induced pruritus and may support the hypothesis that seladelpar decreases pruritus in PBC patients.
Held $178.7 million in cash, cash equivalents and marketable securities at December 31, 2018. Existing cash is expected to fund the current operating plan into 2021.
Fourth Quarter Ended December 31, 2018 Financial Results

There was no collaboration revenue in the fourth quarter of 2018 as compared to $5.2 million of revenue in the same period of 2017. Fourth quarter 2017 revenue earned was primarily due to the achievement of a $5.0 million milestone under a collaboration agreement with Kowa Pharmaceuticals America, Inc.
Research and development expenses were $16.4 million in the fourth quarter of 2018 as compared to $6.7 million in the same period of 2017. The increase was primarily driven by increases in seladelpar-related clinical trial expenses from the expansion and extension of our PBC Phase 2 clinical study, start-up activities related to our ENHANCE PBC Phase 3 clinical study, the ongoing enrollment of our NASH Phase 2b clinical study, and the execution of other NDA-enabling studies.
General and administrative expenses were $4.2 million in the fourth quarter of 2018 as compared to $2.9 million in the same period of 2017. The increase was driven primarily by employee compensation expense as we hired additional personnel to support our expanding operations.
Net loss was $19.4 million, or ($0.32) per diluted share in the fourth quarter of 2018, as compared to $5.0 million, or ($0.11) per diluted share in the same period of 2017. Net loss was higher primarily due to increased research and development expenses and decreased revenues.
Year Ended December 31, 2018 Financial Results

There was no collaboration revenue for the year ended December 31, 2018 as compared to revenue of $10.0 million in the prior year. Collaboration revenue was recognized in 2017 upon the delivery of our performance obligation under a collaboration agreement with Kowa Pharmaceuticals America, Inc.
Research and development expenses were $58.1 million in the year ended December 31, 2018 as compared to $18.9 million in the same period of 2017. The increase was primarily due to increased R&D project costs related to the expansion and extension of our PBC Phase 2 clinical study, start-up activities related to our ENHANCE PBC Phase 3 clinical study, enrollment in our NASH Phase 2b clinical study, and the execution of other NDA-enabling studies. R&D project costs also increased due to manufacturing of seladelpar to support ongoing and planned clinical trials and other development activities. Internal R&D costs also increased, primarily due to higher employee compensation related expenses as additional clinical, scientific and regulatory personnel were hired to support expanding clinical development activities.
General and administrative expenses were $14.4 million in the year ended December 31, 2018, as compared to $12.4 million in the same period of 2017. The increase was primarily due to higher compensation and consulting expenses, partially offset by a decrease in severance.
Net loss was $72.5 million, or ($1.26) per diluted share in the year ended December 31, 2018, as compared to $27.6 million, or ($0.79) per diluted share in the same period of 2017.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss fourth quarter 2018 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13687140. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On February 28, 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 fourth quarter and year ended December 31, 2018 and provided pipeline updates (Press release, AnaptysBio, FEB 28, 2019, View Source [SID1234533777]).

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"We continued to advance the clinical development of our wholly-owned etokimab and ANB019 programs for severe inflammatory disease indications during 2018," said Hamza Suria, president and chief executive officer of AnaptysBio. "Top-line data from our etokimab Phase 2a trial in severe adult eosinophilic asthma patients demonstrated rapid and sustained improvement in Forced Exhaled Volume In One Second versus placebo, with corresponding reduction in blood eosinophil levels. We look forward to announcing four Phase 2 top-line data readouts from ongoing clinical trials of etokimab and ANB019 during 2019 and expanding our pipeline with an IND filing for a new wholly-owned anti-inflammatory antibody program."

Etokimab (ANB020 Anti-IL-33 Program)

In September 2018, the Company announced positive top-line proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in a single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second, or FEV1, which is a measure of lung function, with an eight percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11 percent increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31 percent reduction at Day 2 and a 46 percent reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis. The Company plans to report full data from this trial at a medical conference in 2019. The Company also plans to continue development of etokimab in eosinophilic asthma with a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial, which is expected to be initiated 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.

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

The Company is conducting a randomized, placebo-controlled 50-patient multi-dose Phase 2 trial in palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top line data anticipated in the second half of 2019.
Corporate Highlights

On September 28, 2018, the Company completed an underwritten public offering of 2,530,000 shares of common stock at a price to the public of $94.46, which included the exercise by the underwriters of their option to purchase an additional 330,000 shares of common stock. AnaptysBio, received net proceeds from the offering of $227.5 million, after deducting underwriting discounts and commissions.
Fourth Quarter and Full Year Financial Results

Cash, cash equivalents and investments totaled $500.2 million as of December 31, 2018 compared to $324.3 million as of December 31, 2017, for an increase of $175.9 million. The increase primarily relates to net proceeds received by the Company of $227.5 million from the public offering, partially offset by cash used for operating activities.

Collaboration revenue was $5.0 million for the year ended December 31, 2018, related to a milestone for the first Phase 3 trial of TSR-042 by TESARO. Collaboration revenue was $3.0 million and $10.0 million for the three months and year ended December 31, 2017, respectively, for two TESARO related milestones.

Research and development expenses were $15.9 million and $56.2 million for the three months and year ended December 31, 2018, as compared to $7.6 million and $29.4 million for the three months and year ended December 31, 2017. 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 and year ended December 31, 2018.

General and administrative expenses were $3.7 million and $15.5 million for the three months and year ended December 31, 2018, as compared to $2.5 million and $9.3 million for the three months and year ended December 31, 2017. The increase was primarily attributable to additional personnel-related expenses, including share-based compensation.

Net loss was $17.0 million and $61.7 million for the three months and year ended December 31, 2018, or a net loss per share of $0.64 and $2.50, respectively, as compared to a net loss of $6.9 million and $30.1 million for the three months and year ended December 31, 2017, or a net loss per share of $0.30 and $1.52, respectively.
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 second half of 2019.

On February 28, 2019 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming World Immunotherapy Congress USA, which is part of the Festival of Biologics USA, in San Diego on Tuesday, March 5, 2019 at 2:20 PM, PST (Press release, Personalis, FEB 28, 2019, View Source [SID1234533834]).

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The presentation, entitled "Comprehensive Immunogenomics for Biomarker Discovery from a Single Sample," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT, and will discuss how this platform can be used to overcome the challenges facing immuno-oncology translational and clinical researchers to ultimately enable the development of safer, more effective precision oncology therapeutics and combinations.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Kedar Hastak, PhD, Field Application Scientist.

on February 28, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, TG Therapeutics, FEB 28, 2019, View Source [SID1234533858]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering.

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In addition, the Company announced that it has entered into a debt financing agreement for up to $60.0 million with Hercules Capital, Inc. (NYSE: HTGC), a leader in customizing debt financing for companies in the life sciences and technology-related markets. The first advance of $30.0 million was funded at closing. Two additional advances of $10.0 million may be drawn at the Company’s option, subject to certain clinical trial milestones, and the fourth advance of $10.0 million, is available through December 15, 2020 subject to the approval of Hercules.

The loan will mature on March 1, 2022. Payments under the loan are interest-only for a period of 18 months, followed by equal monthly installments of principal and interest thereafter. The interest-only period may be extended to 24 months contingent upon the Company achieving certain clinical development or fundraising milestones. In connection with the debt financing, the Company issued Hercules a warrant to purchase up to 147,058 of its common shares at an exercise price of $4.08 per share.

Further information with respect to the debt financing agreement with Hercules will be contained in a Current Report to be filed on Form 8-K by the Company with the Securities and Exchange Commission (the "SEC").

TG Therapeutics intends to use the net proceeds of the public offering and the debt facility to fund the ongoing development of ublituximab and umbralisib, for research and development activities and for general corporate purposes.

The public offering of common stock is being made pursuant to a shelf registration statement previously filed with the SEC on May 26, 2017 and declared effective by the SEC on June 13, 2017. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.