On May 8, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present at the Bank of America Merrill Lynch Health Care Conference on Tuesday, May 14, 2019 at 2:20 p.m. PT / 5:20 p.m. ET. The conference will be held May 14-16, 2019 in Las Vegas (Press release, Kura Oncology, MAY 8, 2019, View Source [SID1234535941]).

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A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

On May 8, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, reported its financial results for the first quarter of 2019, and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, MAY 8, 2019, View Source [SID1234535940]).

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Highlights:

Aclaris submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-450, an oral MK2 inhibitor, for the treatment of rheumatoid arthritis (RA) in April 2019. It would be Aclaris’ first internally-developed novel compound to enter the clinical phase of development and its first inflammatory indication adjacent to dermatology. Aclaris expects to begin a Phase 1 clinical trial of ATI-450, an investigational compound, in the second half of 2019.

In April 2019, Aclaris completed enrollment of more than 1,000 patients across two Phase 3 pivotal clinical trials (THWART-1 and THWART-2) investigating A-101 45% Topical Solution, an investigational drug, for the treatment of common warts, and expects to complete enrollment of Aclaris’ open-label safety extension trial (WART-303) evaluating the long-term safety of A-101 45% Topical Solution during the second quarter of 2019.

During the first quarter of 2019, total net revenues were $5.0 million, which included net sales of RHOFADE (oxymetazoline hydrochloride) cream, 1% of $3.7 million, building on the positive momentum from December 2018.

In April 2019, the United States Patent and Trademark Office issued U.S. Patent No. 10,265,258 covering methods of treating alopecia areata (AA) using ruxolitinib or isotopic forms of ruxolitinib. The claims in this issued patent cover the use of an effective amount of isotopic forms of ruxolitinib, such as deuterated ruxolitinib, to treat AA. This patent is exclusively licensed to Aclaris. This represents the continued expansion of the IP estate with numerous claims directed against ruxolitinib, baricitinib, tofacitinib and decernotinib.

o advance with multiple data read outs expected during the course of the year across both our Phase 2 and Phase 3 clinical programs. Additionally, we are excited to move ATI-450, our first internally generated asset, into the clinic in the second half of this year. Our drug discovery engine continues to be productive and we look forward to developing small molecule therapeutics for many inflammatory conditions that need new treatment approaches. Finally, we are pleased with the reception to the relaunch and continued growth of RHOFADE through the first quarter," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Clinical Pipeline Update:

A-101 45% Topical Solution:

Aclaris’ THWART-1 and THWART-2 trials, investigating A-101 45% Topical Solution for the treatment of common warts, are progressing as planned. Aclaris has completed enrollment of more than 1,000 patients across these two trials, and topline data for both trials are expected in the second half of 2019.

An open-label safety extension trial (WART-303) evaluating the long-term safety of A-101 45% Topical Solution for the treatment of common warts is also ongoing and Aclaris expects enrollment to be completed during the second quarter of 2019.

If the results of these trials are positive, NDA submission is expected in the first half of 2020.

JAK Inhibitor Trials:

Aclaris has completed enrollment in all of the following JAK inhibitor trials:

AA-201 Topical – This ongoing Phase 2 randomized, double-blinded, parallel-group, vehicle-controlled trial is evaluating the safety, efficacy and dose response of two concentrations of ATI-502, a topical JAK1/3 inhibitor, on the regrowth of hair in 129 patients with AA. Data are expected during the second quarter of 2019 and if the results from this trial are positive, Aclaris’ next steps may include holding an end of Phase 2 meeting with the FDA, and initiating a Phase 3 trial of ATI-502 as a topical treatment for AA in the first half of 2020.

AGA-201 Topical – This ongoing Phase 2 open-label clinical trial is evaluating the safety and efficacy of ATI-502, a topical JAK1/3 inhibitor, on the regrowth of hair in 31 patients with androgenetic alopecia (AGA), also known as male/female pattern hair loss. 6-month data are expected during the second quarter of 2019 and 12-month data are

expected in the fourth quarter of 2019. If the results from this trial are positive, Aclaris expects to initiate an additional Phase 2 trial of ATI-502 for the topical treatment of AGA in the first half of 2020.

VITI-201 Topical – This ongoing Phase 2 open-label clinical trial is evaluating the safety and efficacy of ATI-502, a topical JAK1/3 inhibitor, on the repigmentation of facial skin in 34 patients with vitiligo. 6-month interim data are expected in mid-2019 and 12-month data are expected in the fourth quarter of 2019.

AD-201 Topical – This ongoing Phase 2 open-label clinical trial is evaluating the safety and efficacy of ATI-502, a topical JAK1/3 inhibitor, in 22 adult patients with moderate-to-severe atopic dermatitis (AD). Data are expected in mid-2019.

AUAT-201 Oral – This ongoing randomized, double-blinded, parallel-group, placebo-controlled trial is evaluating the safety, efficacy and dose response of three concentrations of ATI-501, an oral JAK 1/3 inhibitor, on the regrowth of hair in 87 patients with AA. Data are expected in the second half of 2019.

ATI-450 (MK2 Inhibitor) – In April, Aclaris submitted an IND for ATI-450 for the treatment of RA. Aclaris expects to initiate a Single Ascending Dose / Multiple Ascending Dose Phase 1 trial in approximately 80 patients in the second half of 2019. If the IND is allowed by the FDA, Aclaris expects to initiate a Phase 1 trial in the second half of 2019. If Aclaris successfully completes the Phase 1 trial, Aclaris expects to advance ATI-450 into Phase 2 trials in patients with rheumatoid arthritis and an additional inflammatory indication.

Commercial Update:

Based on IQVIA Xponent data for the rolling 4-week period ended April 19, 2019 compared to the rolling 4-week period ended January 25, 2019, the average weekly RHOFADE prescriptions have increased by 20%, the average number of unique RHOFADE prescribers has increased by 18% and the average number of RHOFADE prescriptions per HCP has increased by 3%.

Total prescriptions for RHOFADE were 11% higher in March 2019 as compared to February 2019, according to the IQVIA Monthly National Prescription Audit data.

RHOFADE is currently covered for 85% of commercially-insured lives and 52% of commercially-insured lives have unrestricted access, according to Managed Markets Insight & Technology data.

Aclaris received approval to market ESKATA (hydrogen peroxide) cutaneous solution, 685 mg for the treatment in adults of seborrheic keratoses that are not pedunculated and have up to a maximum diameter of 15 mm each under the brand name ESKATA in Finland, Iceland, Netherlands, Norway, Belgium and Czech Republic, and under the brand name ESKERIELE in the United Kingdom, Germany and France. Aclaris is seeking a commercial partner or partners to market the medicine as an aesthetic skin treatment in various European countries.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $136.8 million compared to $168.0 million as of December 31, 2018. The $31.2 million decrease during the quarter ended March 31, 2019 included:

Net loss of $37.6 million, $0.8 million of net cash used in working capital, and $0.3 million in property and equipment purchases. These uses were offset by $4.9 million of non-cash stock-based compensation expense and $2.2 million of non-cash depreciation and amortization expense.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2019 will be sufficient to fund its operations into the fourth quarter of 2020, without giving effect to any potential new business development transactions or financing activities.

First Quarter 2019 Financial Results

Net loss was $37.6 million for the first quarter of 2019, compared to $30.2 million for the first quarter of 2018.

Net revenues were $5.0 million for the quarter ended March 31, 2019, which consisted of $3.7 million of net RHOFADE sales, $0.1 million of net ESKATA sales and $1.3 million of contract research revenues. This compared to total revenue of $1.1 million for the quarter ended March 31, 2018, all of which was contract research revenues. Cost of revenues (excluding amortization) was $2.8 million for the quarter ended March 31, 2019, compared to $1.0 million for the quarter ended March 31, 2018. Amortization of definite-lived intangibles was $1.7 million for the quarter ended March 31, 2019 and related to RHOFADE intellectual property acquired in November 2018.

Total operating expenses for the first quarter of 2019 were $37.9 million, compared to $31.1 million for the first quarter of 2018.

Research and development expenses were $19.9 million for the first quarter of 2019, compared to $13.6 million for the first quarter of 2018. The increase of $6.3 million was mainly the result of the continued advancement of Aclaris’ JAK inhibitor and common wart programs, as multiple Phase 2 trials of ATI-501 and ATI-502 and Phase 3 trials of A-101 45% Topical Solution were ongoing in the first quarter of 2019, as well as the increased headcount to support these programs. There was also an increase in preclinical work for ATI-450, Aclaris’ MK2 inhibitor, as the company prepared to file its IND in April 2019.

Sales and marketing expenses were $9.8 million for the first quarter of 2019, compared to $11.2 million for the first quarter of 2018. The decrease of $1.4 million was primarily the result of decreases in direct marketing and professional fees, as well as other commercial and personnel expenses that were incurred in the first quarter of 2018 to support the commercialization and launch of ESKATA in May 2018.

General and administrative expenses were $8.2 million for the first quarter of 2019, compared to $6.3 million for the first quarter of 2018. The increase was driven by headcount increases, professional and legal fees related to the RHOFADE acquisition in November 2018, costs incurred under a transition services agreement with Allergan related to RHOFADE, as well as increased medical affairs activities.

2019 Financial Outlook

Aclaris reiterated its 2019 expected GAAP research and development (R&D) expenses to be in the range of $61 to $64 million, including estimated stock-based compensation of $7 million. This expense guidance for R&D in 2019 contemplates the completion of Aclaris’ Phase 2 clinical trials in AA, open-label trials in AGA, vitiligo and AD, and two pivotal Phase 3 trials in common warts, as well as the further advancement of Aclaris’ preclinical pipeline compounds, including ATI-450 and ATI-1777.

Aclaris reiterated 2019 expected GAAP sales and marketing (S&M) expenses to be in the range of $37 to $40 million, including estimated stock-based compensation of $4 million. This expense guidance for S&M in 2019 contemplates all sales force costs and the selling and marketing initiatives to support Aclaris’ marketed products.

Aclaris reiterated 2019 expected GAAP general and administrative (G&A) expenses to be in the range of $29 to $31 million, including estimated stock-based compensation of $10 million. This expense guidance for G&A in 2019 contemplates additional medical affairs, legal and compliance activities to support Aclaris’ marketed products.

Company to Host Conference Call

Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

On May 8, 2019 Sierra Oncology, Inc. ("Sierra Oncology") (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with unmet needs in hematology and oncology, reported its financial and operational results for the first quarter ended March 31, 2019 (Press release, Sierra Oncology, MAY 8, 2019, View Source [SID1234535939]).

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"During the first quarter, we advanced productive dialogues with regulators in the United States and Europe toward determining the registration path for momelotinib, our Phase 3 drug candidate with a potentially differentiated profile for the treatment of myelofibrosis. These discussions are ongoing, and we remain on track to announce our registration strategy in the second quarter of 2019," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We maintain that a new Phase 3 trial that substantiates the array of clinical benefits on anemia, constitutional symptoms, and spleen observed in the previously completed trials with momelotinib will be the basis for this strategy, and we have started undertaking preparatory activities for this planned study."

"Subsequent to the end of the quarter, we reported compelling preclinical data for SRA737+LDG, our oral Chk1 inhibitor (SRA737) plus non-cytotoxic low dose gemcitabine (LDG), in combination with immunotherapy, in a late-breaking oral presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. These data highlight the ability for this unique combination to function synergistically and demonstrate significant efficacy in an immunotherapy resistant small cell lung cancer (SCLC) model. We are also currently in the process of analyzing preliminary data from our two ongoing Phase 1/2 clinical trials evaluating SRA737 monotherapy and SRA737+LDG combination therapy, and expect to report on these studies and potential next steps in the development path for SRA737 at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting in early June," added Dr. Glover. "For our Cdc7 inhibitor, SRA141, we recently reported preclinical data in a late-breaking poster presented at AACR (Free AACR Whitepaper) 2019 highlighting a potentially novel mechanism of cytotoxicity for SRA141 that is distinct from other agents, and we have prepared for an initial clinical trial of this drug candidate in colorectal cancer."

Q1 2019 Highlights:

Momelotinib:

Momelotinib is a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor that has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related clinical benefits, as well as achieving substantive splenic volume reduction and constitutional symptom control.

Sierra is currently advancing discussions with regulators to determine the registration path for momelotinib and anticipates reporting next steps in the second quarter of 2019. Sierra’s presumed registration strategy envisions conducting one additional Phase 3 trial in second line myelofibrosis patients, in order to recapitulate the meaningful clinical benefits observed in the two previously completed Phase 3 trials.

SRA737:

SRA737 is currently being evaluated in two Phase 1/2 clinical trials in patients with advanced cancer across multiple indications. The SRA737-01 trial is intended to evaluate SRA737’s potential to induce synthetic lethality as monotherapy, while the SRA737-02 trial is intended to evaluate the combination of SRA737 potentiated by non-cytotoxic LDG. Sierra expects to report preliminary data from both trials at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting being held in early June 2019.

In addition, Sierra has designed clinical trials and has conducted preclinical research evaluating SRA737 in combination with other DDR-targeted agents, including poly ADP-ribose polymerase (PARP) inhibitors, as well as with immuno-oncology therapeutics, that could potentially guide the next planned wave of clinical development for this asset. Sierra has an agreement with Janssen Research & Development, LLC (Janssen), under which Janssen has agreed to supply the PARP inhibitor niraparib, facilitating the potential initiation of a PARP inhibitor combination trial with SRA737 for the treatment of prostate cancer. Sierra is currently evaluating the optimal timing to commence this trial within the context of its recently expanded portfolio.

During the first quarter of 2019, Sierra reported preclinical data for SRA737+LDG, in combination with immunotherapy, in a late-breaking oral presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2019. In the study, SRA737+LDG demonstrated significant anti-tumor activity when combined with anti-PD-L1 in a mouse model of SCLC, resulting in durable tumor regressions. These findings provide a mechanistic basis for the growing body of evidence demonstrating a synergistic interplay between replication stress and anti-tumor immune responses and afford a compelling rationale for evaluating SRA737+LDG with immunotherapy in the clinic.

SRA141:

During the first quarter of 2019, Sierra reported preclinical data in a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2019, highlighting a potentially novel mechanism of cytotoxicity for SRA141 that is distinct from other agents. This differentiated mechanism of action, in which SRA141 alters DNA replication dynamics and delays cell cycle progression, could support a unique spectrum of clinical opportunities for SRA141 as both monotherapy and in combination with other agents.

Sierra successfully completed the IND filing process with the FDA for SRA141 in 2018 and has prepared for a potential Phase 1/2 trial with this drug candidate in patients with advanced colorectal cancer. Sierra is currently evaluating the optimal timing to commence this trial within the context of its recently expanded portfolio.

First Quarter 2019 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $10.1 million for the first quarter of 2019, compared to $8.3 million for the first quarter of 2018. The increase was primarily due to an increase of $1.7 million in clinical trial costs related to momelotinib and SRA737 and a $1.3 million increase in personnel-related and allocated overhead costs, partially offset by decreases of $0.8 million in third-party manufacturing costs related to SRA737 and $0.4 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $1.2 million and $1.0 million for the three months ended March 31, 2019 and 2018, respectively.

General and administrative expenses were $3.4 million for the three months ended March 31, 2019 and 2018. General and administrative expenses included non-cash stock-based compensation of $0.5 million for both the first quarter of 2019 and 2018.

Net loss was $13.0 million for the first quarter of 2019, compared to a net loss of $11.5 million for the first quarter of 2018.

Cash and cash equivalents totaled $90.9 million as of March 31, 2019, compared to $106.0 million as of December 31, 2018. At March 31, 2019, there were 74,688,283 shares of common stock issued and outstanding, an additional 13,198,385 issuable upon exercise of stock options and warrants, and a term loan of $4.9 million.

Equity Inducement Plan

On May 6, 2019, the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 18,000 shares of its common stock to two new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity award to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

The options have an exercise price of $1.47 per share, which is equal to the closing price of Sierra’s common stock on the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant.

On May 8, 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 ended March 31, 2019 (Press release, CymaBay Therapeutics, MAY 8, 2019, View Source [SID1234535938]).

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"The first quarter of 2019 was highlighted by significant clinical and regulatory accomplishments that continue to accelerate and support the development of seladelpar in PBC and NASH," said Sujal Shah, President and CEO of CymaBay. "In February, we completed enrollment one quarter ahead of schedule in our 52-week, dose-ranging Phase 2b study of seladelpar in patients with NASH, putting us in a position to announce topline data for changes in liver fat, lipids and transaminases at week 12 before the end of the second quarter. Also in February, we announced the FDA granted seladelpar Breakthrough Therapy Designation for patients with early stage PBC. Our progress supported a successful capital raise in March that will now allow us to advance clinical development of seladelpar into a third inflammatory liver disease, primary sclerosing cholangitis (PSC) in the second half of this year. We could not be more pleased with the progress we have made to date and the depth of our overall development program for seladelpar."

First Quarter Business Highlights

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) as well as changes from baseline to 12 weeks in alanine aminotransferase (ALT), low-density lipoprotein C (LDL-C) and triglycerides are expected before the end of 2Q 2019.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage primary biliary cholangitis (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.
Continued enrollment of 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 and top-line data in 2021.
Data from an ongoing Phase 2 study of seladelpar in PBC and certain preclinical studies were presented at the International Liver Congress 2019 hosted by the European Association for the Study of the Liver in Vienna, Austria.
An interim analysis of data from the ongoing Phase 2 study in PBC highlighted comparable anti-cholestatic and anti-inflammatory effects as well as comparable safety and tolerability for seladelpar in non-cirrhotic PBC patients and those with Child-Pugh A cirrhosis.
First Quarter Ended March 31, 2019 Financial Highlights & Results

Raised $107.7 million in net proceeds through our March public offering of common stock.
Held $264.8 million in cash, cash equivalents and marketable securities at March 31, 2019. Existing cash is expected to fund the current operating plan into 2021.
Research and development expenses were $18.6 million in the first quarter of 2019 as compared to $9.5 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including:
start-up and enrollment activities related to our ENHANCE PBC Phase 3 clinical study
ongoing treatment of patients in our NASH Phase 2b clinical study
continued treatment of patients in our PBC Phase 2 clinical study
execution of other NDA-enabling studies
General and administrative expenses were $5.7 million in the first quarter of 2019 as compared to $3.4 million in the same period of 2018. The increase was driven primarily by higher employee compensation and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $23.1 million, or ($0.37) per diluted share in the first quarter of 2019, as compared to $17.0 million, or ($0.32) per diluted share in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss first quarter 2019 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# 13688866. 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 May 8, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering, developing and commercializing novel vaccines and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Dynavax Technologies, MAY 8, 2019, View Source [SID1234535937]).

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"HEPLISAV-B net product revenue was $5.6 million for the first quarter of this year, which was in line with our expectations," said Eddie Gray, chief executive officer of Dynavax. "As the only two-dose hepatitis B vaccine, we are focused on making HEPLISAV-B the standard of care hepatitis B adult vaccine in the U.S. On the immuno-oncology development front, we will have three SD-101 data presentations at ASCO (Free ASCO Whitepaper)."

First Quarter and Recent Business Highlights

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

First quarter 2019 sales of $5.6 million compared to $3.9 million in the fourth quarter 2018
The company has achieved sales into 3 of the 4 top national retail pharmacy chains, and contracting efforts are underway to secure additional pharmacy partners
More than 1,454 individual customers have purchased HEPLISAV-B since launch
Only 4% of doses sold to date were to customers who have not reordered after at least 45 days
15 of the top 20 Integrated Delivery Networks (IDNs) have made HEPLISAV-B available to order
557 of the targeted 1,419 accounts have made HEPLISAV-B available to order, representing 50% of the targeted adult hepatitis B market
164 of the top 300 targeted customers have ordered HEPLISAV-B
In May, the company announced the enrollment of the first patient in an open-label, single-arm study of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis. The study is designed to evaluate immunogenicity and safety.
Immuno-oncology

SD-101

Three Dynavax abstracts have been accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2019 in June.

Abstract #6039, "Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naive patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)"

Abstract #9534, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy"

Abstract #9555, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy"
DV281

Dynavax presented phase 1b data on inhaled DV281 TLR9 agonist at the 2019 AACR (Free AACR Whitepaper) Annual Meeting. Key highlights from the clinical data presentation include:

In this safety study, two doses of DV281 monotherapy followed by combination with nivolumab was well tolerated

Inhalation of DV281 leads to dose-dependent target engagement as measured by induction of IFN-regulated genes at all evaluated dose levels

DV281 plus nivolumab demonstrates early signs of antitumor activity in heavily pretreated patients
Financial Results

Product Revenue, Net. Dynavax’s first commercial product, HEPLISAV-B, was launched in the first quarter of 2018. Net product revenue for the first quarter of 2019 was $5.6 million, compared to $0.2 million for the first quarter of 2018. Product revenue from sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts and other fees.

Cost of Sales – Product. Cost of sales – product, for the first quarter of 2019 was $1.8 million, compared to $0.2 million for the first quarter of 2018. Included in cost of sales – product, are fill, finish and overhead costs for HEPLISAV-B incurred after U.S. Food and Drug Administration (FDA) approval. A higher percentage of HEPLISAV-B inventory sold in 2019 used components manufactured after FDA approval compared to 2018, when most of the expense associated with product sold was expensed to research and development prior to approval. The company expects its HEPLISAV-B cost of sales to increase in future periods as it produces and then sells inventory that reflects the full cost of manufacturing the product.

R&D Expenses. Research and development expenses for the first quarter of 2019 were $21.2 million, compared to $19.0 million for the first quarter of 2018. The increase reflects additional personnel and clinical trial expense for ongoing development of SD-101 and DV281.

SG&A. Selling, general and administrative expenses for the first quarter of 2019 were $18.3 million, compared to $16.9 million for the first quarter of 2018. The increase was due primarily to additional personnel in support of HEPLISAV-B commercial activities.

Net Loss. Net loss for the first quarter of 2019 was $39.7 million, or $0.62 per basic and diluted share, compared to a net loss of $39.0 million, or $0.63 per basic and diluted share, for the first quarter of 2018.

Cash Position. Cash, cash equivalents and marketable securities totaled $183.2 million at March 31, 2019, compared to $145.5 million at December 31, 2018. In March 2019, Dynavax exercised its option to draw down $75 million of non-dilutive capital under its existing term loan agreement with CRG Servicing LLC.

Conference Call and Webcast Information

Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. To access the call, participants may dial (855) 327-6837 (domestic) or (631) 891-4304 (international) and refer to conference ID 10006654. The live call will be webcast and can be accessed in the "Investors and Media" section of the company’s website at www.dynavax.com. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

For more information about HEPLISAV-B, visit View Source

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.