On May 9, 2018 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase based therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, reported its financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, BioSpecifics Technologies, MAY 9, 2018, View Source [SID1234526362]).

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"We are enthusiastic about the sustained year-over-year revenue growth of our CCH product, XIAFLEX, in its marketed indications, Dupuytren’s Contracture and Peyronie’s Disease, and by the potential progress of the broader CCH development pipeline. During the first quarter of 2018, XIAFLEX became commercially available in Canada for Peyronie’s Disease and our partner Endo reported updated data from the Phase 2b clinical trial of CCH for the treatment of cellulite at the American Society for Aesthetic Plastic Surgery," said Thomas L. Wegman, President of BioSpecifics. "We also remain focused on identifying and developing CCH for medically necessary indications, and we remain on track to report preliminary data later this year for our ongoing Phase 1 clinical trial in uterine fibroids, a painful condition of the reproductive tract in which benign tumors contain large amounts of collagen and we are excited by the potential of CCH to alleviate patients’ symptoms and ultimately avoid invasive surgery."

First Quarter 2018 Financial Results

BioSpecifics reported net income of $4.0 million for the first quarter ended March 31, 2018, or $0.55 per basic share and $0.54 per share on a fully diluted basis, compared to net income of $3.3 million, or $0.47 per basic share and $0.46 per share on a fully diluted basis, for the same period in 2017.

The Company adopted Accounting Standard Codification (ASC) 606, Revenue from Contracts with Customers, as of January 1, 2018, applying the modified-retrospective method, changed the timing of its recognition of royalty and mark-up on cost of goods sold revenue. Beginning in 2018, BioSpecifics recorded these royalty revenues based on estimates of the net sales and mark-up on cost of goods sold that occurred during the relevant period thereby eliminating the previously utilized one quarter lag. Previously, these amounts were not recognized until they were fixed and determinable. In addition, deferred revenue associated with the pre-payment of foreign mark-up on cost of goods sold revenue will no longer be recognized over time based on sales by non-affiliated sub-licensees of Endo outside of the U.S. and, under ASC 606, would have been recognized when the Company amended its License Agreement in 2016. Prior period amounts have not been adjusted and the Company recognized a cumulative-effect adjustment to retained earnings on January 1, 2018 of $10.3 million.

Total revenue for the first quarter ended March 31, 2018 was $7.1 million, compared to $7.7 million for the same period in 2017. The decrease in total revenues for the quarterly period was primarily due to lower mark-up on cost of goods sold revenue in the U.S and prepaid foreign mark-up on cost of goods sold revenue recognized under new revenue standard ASC 606, as of January 1, 2018, which was partially offset by an increase in royalties associated with slightly higher overall net sales of XIAFLEX.

Licensing revenue consists of licensing fees, sublicensing fees and milestones. BioSpecifics recognized licensing revenue for the first quarter ended March 31, 2018 and 2017 of approximately $4,409 in each period.

Research and development (R&D) expenses for the first quarter ended March 31, 2018 were $0.2 million compared to $0.3 million for the same period in 2017.

General and administrative expenses for the first quarter ended March 31, 2018 were $2.1 million, compared to $2.4 million for the same period in 2017.

Provision for income taxes for the first quarter ended March 31, 2017 were $1.1 million, compared to $1.8 million for the same period in 2017.

As of March 31, 2018, BioSpecifics had cash and cash equivalents and investments of $64.2 million, compared to $65.1 million as of December 31, 2017. The Company’s cash and cash equivalents and investments were slightly lower due to the timing of Endo’s payment of its quarterly XIAFLEX royalties, which was received in April 2018.

CCH Pipeline Updates and Anticipated Upcoming Milestones

BioSpecifics manages the development of collagenase clostridium histolyticum (CCH) for the treatment of uterine fibroids and has the right to initiate the development of any new potential indication not licensed by Endo. Endo’s licensed indications include Dupuytren’s Contracture and Peyronie’s Disease, both approved and marketed; in addition to cellulite, adhesive capsulitis, human and canine lipoma, lateral hip fat and plantar fibromatosis.

In April 2018, Endo presented clinical data from the Phase 2b study of CCH for the treatment of cellulite during the Premier Global Hot Topics session at the annual meeting of the American Society for Aesthetic Plastic Surgery (ASAPS). A statistically significant proportion of CCH subjects reported being "Satisfied" or "Very Satisfied" with their cellulite treatment compared to placebo subjects. CCH was also well-tolerated by all dose groups. Most adverse events (AEs) were mild to moderate and primarily limited to the local injection area such as injection site bruising (approximately 75 percent) and injection site pain (approximately 59 percent) with 92 percent of all related AEs were mild to moderate in the CCH group compared to 96 percent in the placebo group.
In April 2018, Paladin Labs, a subsidiary of Endo, announced the commercial availability of XIAFLEX in Canada for the treatment of Peyronie’s Disease.
In February 2018, Endo initiated two Phase 3 clinical trials of CCH for the treatment of cellulite. Top-line results are expected in the first quarter of 2019.
BioSpecifics is conducting an ongoing Phase 1 clinical trial of CCH for the treatment of uterine fibroids with data expected later this year. This Phase 1 open-label dose escalation study is being conducted at the Department of Gynecology & Obstetrics at Johns Hopkins University and is designed to enroll 15 female subjects treated prior to hysterectomy. The trial will assess the safety and tolerability of a single injection of CCH directly into the uterine fibroid under transvaginal ultrasound guidance. The secondary endpoints will assess symptoms of pain and bleeding, quality of life throughout the study in addition to size, collagen content and rate of apoptosis of CCH treated fibroids.

On May 9, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Wednesday, May 16, 2018 at 8:30 a.m. ET to report financial results for the first quarter ended March 31, 2018 and to provide a business overview (Press release, Bio-Path Holdings, MAY 9, 2018, View Source [SID1234526361]).

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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 1096178. A live audio webcast of the call will also be available on the Presentations section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

On May 9, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights and financial results for the first quarter of 2018 (Press release, BeiGene, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348272 [SID1234526360]).

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"We continue to make great progress launching new clinical trials on a global scale for patients with a wide variety of cancers, where we believe our investigational treatments can have a profound impact," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. "We have now enrolled more than 2,300 patients worldwide in more than 30 clinical trials of our investigational agents as of the end of March 2018 and remain on target for our first NDA filings in China later this year."

"Given the significantly reformed regulatory environment in China, as well as important additions to our senior leadership team highlighted by the appointment of Dr. Xiaobin Wu as our General Manager of China and President of BeiGene, Ltd., we are excited about our China and global prospects," continued Mr. Oyler.

Recent Business Highlights

Clinical Programs:

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

Completed enrollment in the Phase 2 pivotal trial in China in patients with Waldenström macroglobulinemia (WM).
Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

Initiated the following trials:

• Global Phase 2 trial in patients with relapsed or refractory mature T- and natural killer (NK)-cell lymphomas; and

• Global Phase 2 trial in patients with previously treated hepatocellular carcinoma (HCC or liver cancer), under collaboration with Celgene Corporation for solid tumors.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

Presented preliminary Phase 1 clinical data in Chinese patients with ovarian or triple-negative breast cancer at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago.
Commercial Products:

Continued to expand potential patient access to ABRAXANE (nanoparticle albumin-bound paclitaxel) in China by obtaining inclusion in the provincial reimbursement drug list in Jiangsu and critical illness insurance in Zhejiang; and

Launched a first-line indication of REVLIMID (lenalidomide) in China following its regulatory approval by the China Food and Drug Administration (CFDA) for the treatment of multiple myeloma (MM) in combination with dexamethasone in adult patients with previously untreated MM who are not eligible for transplant.
Corporate Development:

Appointed J. Samuel Su, former Vice Chairman of the Board of Directors of Yum! Brands, Inc. and Chairman and CEO of its China division, to the BeiGene Board of Directors;

Appointed Dr. Xiaobin Wu to the position of General Manager of China and President of BeiGene, Ltd.;

Appointed Yifei Zhu to the position of China Co-Commercial Head, Sales and Market Access; and

Appointed Dr. Guillaume Vignon to the position of Senior Vice President, Business Development.
Expected Upcoming Milestones in 2018

Zanubrutinib

Present updated Phase 1 clinical data in patients with WM and pooled safety analysis in patients with hematologic malignancies at the 2018 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Stockholm, Sweden, June 14-17;

Present other updated Phase 1 data and China pivotal trial data;

Submit first new drug application (NDA) in China for mantle cell lymphoma;

Complete enrollment in the global Phase 3 trial for WM in Q3 2018; and

Initiate a global head-to-head Phase 3 trial versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia.
Tislelizumab

Present updated Phase 1 data and China pivotal trial data;
Submit first NDA in China for Hodgkin’s lymphoma;

Complete enrollment in the Phase 2 pivotal trial in China for urothelial carcinoma; and
Initiate additional pivotal trials.

Pamiparib

Present updated Phase 1 data;

Initiate a global Phase 3 trial in gastric cancer in Q2 or Q3 2018; and
Initiate a Phase 3 trial in China as maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.
Commercial Products

Continue to expand provincial reimbursement for ABRAXANE in China.
First Quarter 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1,481.48 million as of March 31, 2018, compared to $837.52 million as of December 31, 2017. The increase was primarily due to net proceeds of $757.59 million raised in a public offering in January 2018. Cash, cash equivalents, restricted cash and short-term investments include approximately $131.04 million held by our 95%-owned joint venture, BeiGene Biologics, to build a commercial biologics facility under construction in Guangzhou, China. Restricted cash of $17.46 million relates to BeiGene Guangzhou Factory’s secured deposits that are held in designated bank accounts for the issuance of a letter of credit.

Cash used in operations for the quarter ended March 31, 2018 was $104.50 million, compared to $35.71 million for the same period in 2017. The increase was primarily attributable to higher operating expenses in support of our clinical programs and organizational growth. Capital expenditures for the quarter ended March 31, 2018 were $9.70 million, compared to $7.39 million for the same period in 2017. The increase was primarily attributable to the construction of our manufacturing facilities in Guangzhou.

Revenues for the three months ended March 31, 2018 were $32.54 million, compared to nil in the same period in 2017, attributable to product and collaboration revenue under our collaboration with Celgene.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $23.25 million for the first quarter 2018.

Collaboration revenue totaled $9.29 million for the first quarter 2018, reflecting $7.55 million that was recognized as research and development reimbursement revenue from Celgene and $1.74 million of deferred upfront fees from Celgene recognized in the first quarter of 2018. In addition, unbilled receivables of $23.86 million on the balance sheet reflect research and development reimbursement under the Celgene collaboration for expenses incurred through the first quarter of 2018.
Expenses for the quarter ended March 31, 2018 were $143.35 million, compared to $51.54 million in the same period 2017, consisting primarily of the following:

Cost of sales for the first quarter were $4.55 million, compared to nil in the first quarter of 2017. Cost of sales relates to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the three months ended March 31, 2018 were $109.70, compared to $42.77 million in the same period in 2017. The increase in R&D expenses was primarily attributable to increased spending on our ongoing late-stage clinical trials and increased employee compensation expense as a result of increased headcount to support our clinical programs. Also contributing to the increase was the up-front license fee of $10 million paid to Mirati Therapeutics for the license of sitravatinib in Asia (excluding Japan), Australia and New Zealand. R&D-associated share-based compensation expense was $12.05 million for the three months ended March 31, 2018, compared to $4.53 million for the same period in 2017, due to increased headcount and a higher share price.

SG&A Expenses for the three months ended March 31, 2018 were $28.92 million, compared to $8.77 million in the same period in 2017. The increase in SG&A expenses was primarily attributable to increased headcount, including employees transferred from Celgene China in connection with the license agreement for Celgene’s commercial products in China, as well as higher professional service fees and costs to support our growing operations. SG&A-associated share-based compensation expense was $5.34 million for the three months ended March 31, 2018, compared to $1.46 million for the same period in 2017, due to increased headcount and a higher share price.

Net Loss for the first quarter of 2018 was $105.12 million, or $2.03 per American Depositary Share (ADS), compared to a net loss of $50.62 million, or $1.27 per ADS in the same period in 2017.

On May 9, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that Natalie Holles, President and Chief Operating Officer, will present at the Bank of America Merrill Lynch Health Care Conference in Las Vegas, NV (Press release, Audentes Therapeutics, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348070 [SID1234526345]). The presentation is scheduled for Wednesday, May 16, 2018, at 11:20 am PT.

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To access a live webcast of the presentation, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. A replay of the live webcast will be available on the Audentes website for approximately 30 days following the conference.

On May 9, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported financial results and recent corporate updates for the first quarter ended March 31, 2018 (Press release, Arcus Biosciences, MAY 9, 2018, View Source [SID1234526344]).

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"The first quarter of 2018 was another exciting period for the Company, as our immuno-oncology pipeline continues to advance," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "We have submitted regulatory filings to initiate our first combination trials of AB928, our internally discovered dual adenosine receptor antagonist, with other anti-cancer agents, including our anti-PD-1 antibody, AB122, and expect to initiate dosing in patients in mid-2018. We are also on track to submit regulatory filings for our next two product candidates, AB154 and AB680, in the third quarter, and to end the year with four product candidates in clinical development."

Pipeline Updates and Upcoming Milestones

AB928 (dual A 2 R receptor antagonist)

Initiated the submission of regulatory filings for three Phase 1/1b trials to evaluate AB928 in combination with AB122 or chemotherapy. Each trial will evaluate AB928 in combination with AB122 and/or chemotherapy in selected tumor types and will be conducted in both Australia and the U.S. The trial protocols were designed to allow for the addition of other AB928 combinations over time, including triple combinations. There will be a dose-escalation portion which will be followed by dose-expansion cohorts once the recommended dose of AB928 for each combination has been selected. In both the dose-escalation portion and expansion cohorts, the Company will conduct significant biomarker analysis, designed to inform patient selection in future trials. Data from the dose-escalation portion of these trials will be presented in the first half of 2019. The three trials will evaluate AB928 combinations in the following tumor types:
— Gastrointestinal malignancies (initially colorectal and gastroesophageal cancers)
— Breast and gynecological (initially ovarian) malignancies
— Non-small cell lung cancer and renal cell carcinoma
Completed dosing in the ongoing Phase 1 double-blinded, placebo-controlled trial in healthy volunteers in April. Final results from this trial, including pharmacodynamic data for the 200 mg QD dosing cohort, are expected to be released in mid-2018.
Presented initial data from the Phase 1 trial in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data showed AB928 is safe and well tolerated at all doses evaluated (up to 200 mg QD) and achieves near complete inhibition of adenosine 2a receptor (A2aR) activation.
Presented preclinical data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB928 in combination with doxorubicin or oxaliplatin results in greater immune activation and tumor control than that of chemotherapy alone in two different tumor models.
AB122 (anti-PD-1 antibody)

Initiated dosing of a third cohort in the ongoing Phase 1 dose-escalation trial in cancer patients in Australia. The Company plans to present safety, pharmacokinetic, receptor occupancy and clinical activity data from this trial in the second half of 2018.
Presented preclinical data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB122 is similar to nivolumab in terms of binding affinity, selectivity and anti-tumor activity in an animal model.
AB154 (anti-TIGIT antibody)

Continued to advance CMC activities and GLP toxicology studies. These studies are being conducted in preparation for the first regulatory submission for AB154 expected in mid-2018.
AB680 (small molecule CD73 inhibitor)

Presented preclinical discovery and characterization data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB680 significantly enhanced the activity of anti-PD-1 and anti-TIGIT antibodies (AB122 and AB154, respectively) in immune function assays demonstrating the potential of triple combination therapy. This drug has a predicted half-life in humans of several days, which should allow for a dosing regimen of every two or three weeks.
Preparing to submit the first regulatory filing to initiate a Phase 1 trial to evaluate AB680 in healthy volunteers. This trial, which is expected to start in the third quarter of 2018, is designed to evaluate the safety, pharmacokinetic and pharmacodynamic profile of AB680 in healthy volunteers. Clinical testing of AB680 in cancer patients is expected to begin in the first half of 2019.
Corporate Updates

The Company completed an initial public offering in March, raising approximately $124.7 million in net proceeds after deducting underwriter discounts and other offering-related costs through the sale of 9,200,000 shares of common stock at a public offering price of $15.00 per share. Proceeds from this offering are currently expected to fund the company into at least 2020.
First Quarter Financial Results:

At March 31, 2018, cash, cash equivalents and investments were $290.8 million, compared to $175.7 million at December 31, 2017. The increase was primarily due to the receipt of $124.7 million in net proceeds from the Company’s initial public offering, which was completed in March.
Collaboration and license revenue for the first quarter ended March 31, 2018 was $1.3 million, compared to no revenue for the same period in 2017. The increase in revenue was entirely due to revenue recognized from the Option and License Agreement the Company entered into with Taiho Pharmaceutical Co., Ltd. in September 2017.
Research and development expenses for the first quarter ended March 31, 2018 were $11.7 million, compared to $5.8 million for the same period in 2017. The increase of $5.9 million was primarily due to an increase in manufacturing and clinical costs to support our ongoing AB928 and AB122 clinical trials and an increase in R&D headcount to support the Company’s other programs.
General and administrative expenses for the first quarter ended March 31, 2018 were $2.9 million, compared to $1.5 million for the same period in 2017. The increase of $1.4 million was primarily due to higher legal and accounting fees and additional staff in key areas required to support a public company infrastructure, as well as increased facilities and office expenses related to our expanded facility in Hayward.
Net loss for the first quarter ended March 31, 2018 was $13.0 million, compared to $7.2 million for the same period in 2017. The increase in net loss was primarily attributable to the increase in operating expenses noted above.