On August 9, 2018 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 six months ended June 30, 2018 (Press release, CymaBay Therapeutics, AUG 9, 2018, View Source [SID1234528710]).

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"Having completed a significant capital raise to start the year, we are now laser focused on high quality execution as we continue to advance novel treatment alternatives to patients suffering from liver diseases with significant unmet needs," said Sujal Shah, President and Chief Executive Officer of CymaBay. "We have collected feedback from regulatory agencies and finalized our design for our planned Phase 3 study of seladelpar in primary biliary cholangitis (PBC) and we are on track to initiate this study in the second half of the year. Data from the ongoing Phase 2 study of seladelpar in patients with PBC were presented in a late-breaking presentation at The International Liver CongressTM in April, and we believe these data support the potential of seladelpar to provide improved efficacy and better tolerability over existing second-line therapy. We are also excited to expand development of seladelpar into non-alcoholic steatohepatitis (NASH) with the recent initiation of a Phase 2b proof-of-concept study. We believe seladelpar’s PPAR-delta mechanism of action may be particularly well suited to treat NASH given its beneficial impacts on lipid, glucose, and sterol metabolism, as well as its effects on inflammation and fibrogenesis."

Second Quarter 2018 Business Highlights

Announced plans to proceed with a double-blind, placebo-controlled Phase 3 pivotal study of seladelpar in PBC. The study intends to enroll approximately 240 patients randomized to receive either 5 mg or 10 mg seladelpar, or placebo. Patients who have an inadequate response on the 5 mg dose will have the potential to increase to 10 mg after 6 months.
Presented new 12-week and 26-week results from the ongoing Phase 2 study of seladelpar in primary biliary cholangitis (PBC) at The International Liver CongressTM in April.
• The results showed potent anti-cholestatic and anti-inflammatory activities, with no drug-induced pruritus, through 26 weeks of treatment.
• 52-week data from this study are expected to be announced in the fourth quarter of 2018.
Initiated a Phase 2b proof-of-concept study of seladelpar for the treatment of NASH. This randomized, placebo-controlled, parallel, dose-ranging study is intended to enroll approximately 175 patients with liver biopsy proven NASH. The primary efficacy outcome is change in liver fat content from baseline to 12 weeks as measured by magnetic resonance imaging. The secondary analysis includes evaluation of histological improvement in NASH and fibrosis as assessed by comparing liver biopsy samples taken at baseline and 52 weeks.
Added CBAY to the Russell 3000 and the Russell 2000 Indexes at the conclusion of the Russell US Indexes annual reconstitution.
Expanded workforce with clinical, regulatory, scientific and administrative personnel necessary to support expansion of clinical programs, notably the Phase 3 PBC registration study, and business operations.
Amended the existing corporate office lease to extend it for an additional 5-year term and relocate to a larger facility within current corporate campus location.
Second Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities totaled $212.1 million at June 30, 2018. Based on current projections, existing cash is expected to fund the current operating plan into 2021.
Term loan facility repaid in full resulting in a debt-free balance sheet at June 30, 2018.
No collaboration revenue was recognized in the second quarter of 2018.
Research and development expenses were $14.4 million in the second quarter of 2018 as compared to $4.0 million in the same period of 2017 and consisted primarily of higher clinical trial expenses related to ongoing PBC Phase 2 and extension studies, start-up activities for the planned PBC Phase 3 study, and enrollment activities associated with the recently initiated NASH Phase 2b study. Additionally, higher seladelpar drug manufacturing expenses were incurred to provide clinical supplies to these studies.
General and administrative expenses were unchanged at $3.6 million in the second quarter of 2018 and 2017.
Net loss was $17.5 million, or ($0.30) per share in the second quarter of 2018, as compared to $8.9 million, or ($0.31) per share in the second quarter of 2017. Net loss was higher primarily due to increased research and development expenses incurred to support expanding clinical studies.
First Half 2018 Financial Results

No collaboration revenue was recognized in the first half of 2018 as compared to $4.8 million in the same period of 2017. Revenue associated with the collaboration arrangement with Kowa Pharmaceuticals America was recognized in 2017 upon transfer of a license and know how to Kowa.
Research and development expenses were $23.9 million in the first half of 2018 as compared to $8.1 million in the same period of 2017 and consisted primarily of higher clinical trial expenses related to ongoing PBC Phase 2 and extension studies, start-up activities for the planned PBC Phase 3 study, and enrollment activities associated with the recently initiated NASH Phase 2b study. Additionally, higher seladelpar drug manufacturing expenses were incurred to provide clinical supplies to these studies.
General and administrative expenses were $6.9 million in the first half of 2018, as compared to $7.3 million in the first half of 2017. Expenses were higher in 2017 primarily due to severance expenses associated with the retirement of CymaBay’s former CEO.
Net loss was $34.5 million, or ($0.61) per share in the first half of 2018, as compared to $14.3 million, or ($0.52) per share in the second quarter of 2017. Net loss was higher primarily due to increased research and development expenses incurred to support the expanding clinical studies and lower collaboration revenue.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss second 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# 13680965. 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 August 9, 2018 Juniper Pharmaceuticals, Inc. (Nasdaq:JNP), a diversified healthcare company with core businesses of its CRINONE (progesterone gel) franchise and fee-for-service pharmaceutical development and manufacturing business, Juniper Pharma Services ("JPS"), reported financial results for the quarterly period ended June 30, 2018 (Press release, Juniper Pharmaceuticals, AUG 9, 2018, View Source [SID1234528709]). Cash and equivalents were $20.8 million at June 30, 2018 compared to $20.7 million at March 31, 2018.

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"Last month, we achieved the key objective in our efforts to maximize shareholder value, announcing a definitive agreement with Catalent, Inc. for the acquisition of all outstanding shares of Juniper at terms which reflect the value of our businesses," said Alicia Secor, Chief Executive Officer. "We would like to thank our shareholders for their continued support."

Second Quarter and Recent Corporate Highlights

Signed a definitive agreement for Catalent, Inc. ("Catalent") to acquire all outstanding shares of Juniper Pharmaceuticals, Inc. ("Juniper" or "Juniper Pharmaceuticals"). The transaction, approved unanimously by the Juniper Board of Directors, represents a total equity value of approximately $139.6 million on a fully-diluted basis. Under the terms of the definitive agreement, Catalent has commenced a tender offer to acquire all of the outstanding shares of Juniper’s common stock at a price of $11.50 per share. The closing of the tender offer will be subject to a majority of Juniper’s outstanding shares being tendered in the tender offer. In addition, the transaction is subject to other customary closing conditions. Following completion of the tender offer, Catalent will acquire all remaining shares at the same price of $11.50 per share through a second step merger, other than shares that have properly effected appraisal rights. The closing of the transaction is expected to take place in the third quarter of 2018.
Signed an exclusive, worldwide license agreement with Daré Bioscience, Inc. ("Daré") for the development and commercialization of Juniper’s intravaginal ring ("IVR") technology platform, including its three preclinical IVR candidates targeting unmet needs in women’s health. Under the agreement, Daré will be responsible for conducting all research, development and commercial activities for this program.
Second Quarter 2018 Financial Results

Second quarter 2018 total revenues increased 10% to $15.3 million, compared with $14.0 million for the quarter ended June 30, 2017.

Product revenues were $9.3 million compared to $9.6 million in the second quarter of 2017.

Service revenues from JPS were $5.7 million, an increase of $1.3 million, versus $4.4 million in the second quarter of last year, driven by new and existing customer growth.

Gross profit was $6.2 million as compared to $6.3 million in the prior year quarter.

Total operating expenses were $8.1 million in the second quarter of 2018, compared to $6.7 million in the prior year quarter. The increase is largely attributed to transaction-related costs.

Juniper recorded net loss of $1.5 million in the second quarter of 2018, or $0.14 net loss per diluted share, compared to a net loss of $0.4 million, or $0.03 net loss per diluted share, in the same period of 2017.

Liquidity

Cash and cash equivalents were $20.8 million as of June 30, 2018 versus $20.7 million at March 31, 2018.

On August 9, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported its financial results for the quarter ended June 30, 2018 (Press release, Stemline Therapeutics, AUG 9, 2018, View Source [SID1234528708]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

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ELZONRIS (SL-401, tagraxofusp) – BLA submission completed

We completed submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ELZONRIS, which has been granted breakthrough therapy designation (BTD), for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). If successful, we anticipate acceptance of our BLA within 60 days of submission (i.e. in the coming weeks) and potential U.S. marketing approval by 1Q19, or possibly sooner.

Data from our pivotal trial in patients with BPDCN was the subject of an oral presentation at the 23rdCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden.

We anticipate feedback from the European Medicines Agency (EMA) later this year regarding a potential ELZONRIS regulatory filing in Europe.

In preparation for potential marketing approval, we continue to build out our pre-launch and commercial activities, including our disease awareness campaign targeting key stakeholders including hematologist-oncologists, dermatologists, and pathologists.
ELZONRIS – Other potential indications

ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).

Clinical data from ongoing trials in patients with CMML and MF were selected for presentation at EHA (Free EHA Whitepaper) in June.

In relapsed/refractory CMML (n=16 patients), ELZONRIS demonstrated 100% (8/8) spleen responses in evaluable patients with baseline splenomegaly by physical exam and 2 bone marrow complete responses (BMCRs), coupled with a tolerable safety profile. Given the results observed to date, we are currently formulating registrational trial designs.

In relapsed/refractory MF (n=15 patients), ELZONRIS demonstrated 50% (6/12) spleen responses in evaluable patients with baseline splenomegaly (>5 cm palpable below the costal margin by physical exam), coupled with a tolerable safety profile. Given the results observed to date, we are currently evaluating next steps including possible registrational trial designs.
SL-801

Data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June. Patient enrollment and dose escalation continues.
SL-701

Data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were presented at the 2018 ASCO (Free ASCO Whitepaper) meeting in June. Notably, there were long-term (>12 month) overall survivors in the SL-701+bevacizumab cohort which consisted primarily of patients who demonstrated an elevated immune response (i.e. potentially representing an "immunocompetent" population). Further analyses, including registration-directed designs are ongoing.
Ivan Bergstein, MD, CEO of Stemline, commented, "We have completed our rolling BLA submission and are quickly approaching the very important milestone of a potential BLA acceptance for filing by the FDA. We continue to advance closer to our ultimate goal of potentially making ELZONRIS widely available to patients with BPDCN. In parallel, ELZONRIS continues to generate very promising clinical data in additional indications including CMML and MF, two settings of unmet medical need for which we are actively evaluating registration pathways. Additionally, we continue to expand our commercial infrastructure including the build out of our sales and marketing teams ahead of our potential approval."

Second Quarter 2018 Financial Results Review
Stemline ended the second quarter of 2018 with $97.1 million in cash, cash equivalents and investments, with a cash burn of $17.6 million in the second quarter. The Company ended the second quarter of 2018 with 30.9 million shares outstanding. For the second quarter of 2018, Stemline had a net loss of $18.9 million, or $0.66 per share, compared with a net loss of $15.5 million, or $0.66 per share, for the same period in 2017.

Research and development expense was $11.2 million for the quarter ended June 30, 2018, compared with $11.5 million for the quarter ended June 30, 2017, representing a decrease of $0.3 million.

General and administrative expense was $8.6 million for the quarter ended June 30, 2018, compared with $4.5 million for the quarter ended June 30, 2017, representing an increase of $4.1 million. The increase in expense was primarily attributed to a $3.0 million increase in pre-launch expenses in support of our potential commercialization of ELZONRIS in BPDCN, if marketing approval from the FDA is received. Additionally, the higher expense was also due to an increase of non-cash stock-based compensation expense and increased headcount.

On August 9, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported financial results for the second quarter ended June 30, 2018 (Press release, Aeglea BioTherapeutics, AUG 9, 2018, View Source [SID1234528707]).

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"We made good progress in the second quarter with our clinical programs, and we completed a follow-on financing that sets the stage for an exciting second half of the year," said Anthony G. Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "We are looking forward to providing clinical updates at a number of medical conferences in the fall, including reporting the latest interim data from both our Arginase 1 Deficiency and cancer development programs. We also will provide updates on our clinical trial enrollment and our progress with one of our research enzyme programs, which we believe shows promise for treating the metabolic disorder homocystinuria."

"With the management team we now have in place, Aeglea is ready to take the next step in advancing therapies with the potential to improve the lives of patients with devastating diseases. I believe the Company is well positioned for future growth with our current pipeline programs and our expanded in-house drug-hunting capabilities," added Dr. Quinn.

Recent Highlights

In July, the Company’s Board of Directors named Anthony G. Quinn, M.B. Ch.B, Ph.D. as president and chief executive officer. Dr. Quinn has been a member of the Board of Directors since 2016 and had served as interim CEO since July 2017. Prior to joining Aeglea, Dr. Quinn served as executive vice president, head of research and development, and chief medical officer at Synageva Biopharma Corp., prior to its acquisition by Alexion Pharmaceuticals.
In July, the Company announced the appointment of Bryan Lawlis, Ph.D., as an independent director. Dr. Lawlis served as CEO of Itero Biopharmaceuticals, LLC from 2011 to 2017 and from 2007 to 2011 was co-founder and CEO of Itero Biopharmaceuticals, Inc. He is currently on the boards of Biomarin Pharmaceutical, Inc., Geron, Inc., and Coherus Biosciences, Inc.
Upcoming Events

Dr. Quinn will present a corporate update at the Wells Fargo Healthcare Conference being held September 5 – 6 in Boston, MA. Details regarding the date and time of the presentation and webcast will be announced before the conference.
Aeglea will present new interim Phase 1/2 clinical trial data demonstrating clinically relevant treatment effects in patients with Arginase 1 Deficiency at the 2018 Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium being held September 4 – 7 in Athens, Greece.
Title: Improvements in Arginase 1 Deficiency-related disease manifestations following plasma arginine reduction with pegzilarginase
Poster #P-164
Presentation Date/Time: Wednesday, September 5 at 5:45 p.m. – 8:30 p.m. EET and Thursday, September 6 at 12:15 p.m. – 1:15 p.m. EET
Aeglea will deliver three poster presentations detailing clinical and preclinical data at the American Society of Human Genetics (ASHG) 2018 Annual Meeting being held October 16 – 20 in San Diego, California (schedule details to be announced):
Interim Phase 1/2 clinical trial data for the treatment of Arginase 1 Deficiency that will include additional clinical insights from recently enrolled adult and pediatric patients, as well as from longer-term dosing in previously enrolled patients
Title: Improvements in Arginase 1 Deficiency-related disease manifestations following plasma arginine reduction with pegzilarginase: early Phase 2 results
The effects of a novel homocysteine degrading enzyme in a preclinical model of homocystinuria.
Title: Improved survival and amelioration of disease-related liver pathology in a mouse model of homocystinuria with a novel homocysteine degrading enzyme
Summary of disease manifestation in Arginase 1 Deficiency case reports from scientific literature
Title: Clinical features of Arginase 1 Deficiency: Review of Literature Case Series
Aeglea will present interim Phase 1 advanced solid tumor clinical trial data on melanoma expansion cohorts at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress being held October 19 – 23 in Munich, Germany.
Title: Initial cohort expansion results of sustained arginine depletion with pegzilarginase in melanoma patients in a Phase 1 advanced solid tumor trial
Abstract #1269P
Presentation Date/Time: Sunday, October 21 at 1:35 p.m. – 2:35 p.m. CEST
Second Quarter 2018 Financial Results

As of June 30, 2018, Aeglea had available cash, cash equivalents and marketable securities of $72.2 million, which includes $37.7 million in net proceeds from a follow-on public offering that closed in April 2018. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations to the middle of 2020.

Aeglea recognized grant revenues of $2.4 million in the second quarter of 2018, compared with $1.5 million in the second quarter of 2017. The grant revenues were the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The revenue increase was primarily due to higher qualifying expenditures associated with the clinical trials for pegzilarginase in cancer patients in the second quarter of 2018 compared with the second quarter of 2017. Additionally, the grant contract ended in May 2018 with the full $19.8 million grant recognized as revenue over the life of the award. As of June 30, 2018, Aeglea had a remaining grant receivable totaling $4.3 million.

Research and development expenses totaled $9.1 million for the second quarter of 2018, compared with $5.8 million for the second quarter of 2017. The increase was primarily due to expanded clinical activity for Aeglea’s lead product candidate, pegzilarginase, as Aeglea advanced a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and initiated single-agent cohort expansions in a Phase 1 clinical trial for advanced solid tumor patients and a Phase 1/2 combination trial in patients with small cell lung cancer.

General and administrative expenses totaled $2.9 million for the second quarter of 2018, compared with $2.4 million in the second quarter of 2017. This increase was primarily due to additional employee compensation costs related to the building out of Aeglea’s management team as well as to support expanding research and development activities. Non-cash stock compensation expense accounted for $0.2 million of the increase.

Net loss totaled $9.4 million and $6.6 million for the second quarter of 2018 and 2017, respectively, with non-cash stock compensation expense of $1.0 million and $0.7 million for the second quarter of 2018 and 2017, respectively.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Aeglea also announced today that the Compensation Committee of its Board of Directors has granted non-qualified stock options to purchase an aggregate of 2,400 shares of Aeglea’s common stock to two new employees under Aeglea’s 2018 Equity Inducement Plan.

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

The options have an exercise price of $8.98 per share, which is equal to the closing price of Aeglea’s common stock on August 7, 2018. Each of the option awards vests as to 25% of the shares on the one-year anniversary of its grant, with the remainder of the shares vesting ratably over 36 months thereafter.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency, a debilitating urea cycle disorder caused by deficiency of a key arginine metabolizing enzyme that leads to severe and progressive hyperargininemia-related neurological abnormalities, hyperammonemia and early mortality. Pegzilarginase is intended for use as an enzyme replacement therapy in patients to reduce elevated blood arginine levels. The Company’s interim Phase 1/2 data demonstrated clinically relevant treatment effects and rapid and sustained lowering of plasma arginine in Arginase 1 Deficiency patients.

About Pegzilarginase in Cancer

Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. In some cancers, tumor cells stop producing specific amino acids and must acquire them from the blood, making the tumor cells susceptible to starvation through depletion of those amino acids. Aeglea is developing pegzilarginase to exploit vulnerabilities in some cancers that lead to an increased dependency on extracellular arginine. Pegzilarginase targets these arginine dependent cancers by depleting blood arginine levels to below the normal range. Preclinical data demonstrated that the resulting arginine starvation inhibits proliferation, induces cell death, increases turnover of cell components and promotes anti-tumor immune responses. The Company’s Phase 1 data in advanced solid tumors demonstrated that pegzilarginase was well tolerated at doses that produced marked and sustained reductions in blood arginine levels below the normal range.

On August 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 second quarter ended June 30, 2018 and provided a corporate update (Press release, BioSpecifics Technologies, AUG 9, 2018, View Source [SID1234528706]).

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BioSpecifics Technologies Corp. Logo

"The first half of 2018 was a period of significant clinical development for XIAFLEX. We continued to focus on the execution of our ongoing Phase 1 clinical trial in uterine fibroids and have now completed patient enrollment. Uterine fibroids are the most prevalent tumor of the female reproductive tract, for which non-invasive treatment options are very limited, and we expect to report top-line data later this year. Additionally, our partner Our Endo reported rapid enrollment in the second quarter for the Phase 3 clinical trials for the treatment of cellulite, and we now anticipate top-line data in the fourth quarter of 2018," said Thomas L. Wegman, President of BioSpecifics. "On the commercial front, we were also pleased with the sustained revenue growth and continued efforts of the direct to consumer advertising campaigns for XIAFLEX in its two commercial indications, Dupuytren’s Contracture and Peyronie’s Disease, and we reported second quarter 2018 revenues of $7.1 million. These revenues were driven by Endo’s reported 27 percent revenue growth year-over-year and our partner also increased their full year revenue guidance into the high-teens percentage growth range."

Second Quarter 2018 Financial Results

BioSpecifics reported net income of $4.3 million for the second quarter ended June 30, 2018, or $0.60 per basic share and $0.59 per share on a fully diluted basis, compared to net income of $2.6 million, or $0.37 per basic share and $0.36 per share on a fully diluted basis, for the same period in 2017.

Total revenue for the second quarter ended June 30, 2018 was $7.1 million, compared to $6.5 million for the same period in 2017. The increase in total revenues for the quarterly period was primarily due to an increase in royalties associated with higher net sales of XIAFLEX which was partially offset by 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.

Licensing revenue consists of licensing fees, sublicensing fees and milestones. BioSpecifics recognized licensing revenue for the second quarter ended June 30, 2018 of $35,270 and $4,409 for the same period in 2017.

Research and development (R&D) expenses for the second quarter ended June 30, 2018 were $0.2 million compared to $0.3 million for the same period in 2017. The decrease in the 2018 period, as compared to the 2017 period, was mainly due to lower consulting fees associated with clinical, preclinical and other R&D programs.

General and administrative expenses for the second quarter ended June 30, 2018 were $2.0 million, compared to $2.3 million for the same period in 2017. The decrease in general and administrative expenses was mainly due to the lower consulting and patent fees partially offset by higher amortization associated with deferred royalty buy-down and third-party royalties associated with XIAFLEX.

Provision for income taxes for the second quarter ended June 30, 2018 were $1.0 million, compared to $1.4 million for the same period in 2017.

As of June 30, 2018, BioSpecifics had cash and cash equivalents and investments of $73.7 million, compared to $65.1 million as of December 31, 2017.

The BioSpecifics Board of Directors has authorized an increase in the repurchase amount in the Company’s stock repurchase program, previously approved by the Board in August 2015, under which BioSpecifics is authorized to repurchase up to $3.0 million of its outstanding common stock. This decision reflects BioSpecifics’ positive outlook for the future, confidence it will remain profitable on an ongoing annual basis and its continued commitment to increasing value for its stockholders.

Pursuant to the repurchase program, BioSpecifics plans to repurchase stock through a broker in the open market, provided that the timing, actual number and price per share of the common stock to be purchased will be subject to market conditions, applicable legal requirements, including Rule 10b-18 of the Securities Exchange Act of 1934, as amended, and various other factors. BioSpecifics intends to hold any reacquired stock in treasury. The repurchase program may be suspended or discontinued at any time by the Board of Directors. BioSpecifics has no obligation to repurchase common stock under the repurchase program.

As of June 30, 2018, BioSpecifics had 7,244,233 shares of common stock outstanding.

XIAFLEX/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.

Endo is conducting two ongoing Phase 3 clinical trials of CCH for the treatment of cellulite. Top-line results are expected in the fourth quarter of 2018.
BioSpecifics has completed patient enrollment in its Phase 1 clinical trial of CCH for the treatment of uterine fibroids with top-line data expected in late 2018. 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.
XIAFLEX future growth initiatives continue to support the increase in disease state awareness for both Peyronie’s Disease and Dupuytren’s Contracture through direct to consumer campaigns.