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.

On August 9, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported financial results for the second quarter of 2018 ended June 30, 2018, and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, AUG 9, 2018, View Source [SID1234528705]).

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"The second quarter of 2018 was characterized by intense focus on execution of our clinical programs. We remain on track to update investors with data from all three programs before year end. Our lead IO program, PRS-343, continues to advance apace in a dose-escalation study, and we expect to initiate a trial in combination with atezolizumab (Tecentriq) later this year. For PRS-060, our inhaled IL-4 receptor alpha antagonist program, we successfully completed the single-ascending dose inhalation phase in healthy volunteers and recently initiated a multiple-ascending dose study in subjects with mild asthma to test for early proof of concept via biomarkers. Our anchor alliances with AstraZeneca for respiratory diseases and with Servier and Seattle Genetics for immuno-oncology, which account for more than five active programs within our pipeline and represent a cornerstone of our strategy of managing risk through diversification and shared investments, are also progressing well," said Stephen S. Yoder, President and CEO of Pieris. "With our team’s clinical execution performance and our commitment to further mature our immuno-oncology franchise with two expected IND filings next year, we believe we are well-positioned to deliver on our milestones and create long-term value for our shareholders."

PRS-343: Pieris intends to report initial pharmacokinetic, safety, tolerability and biomarker data for its PRS-343 Phase I study for the treatment of HER2+ solid tumors in the fourth quarter of 2018. PRS-343, the first bispecific costimulatory T-cell agonist to enter the clinic, is a fully-proprietary immuno-oncology drug candidate composed of Anticalin proteins targeting 4-1BB genetically fused to an antibody targeting HER2. Pieris also intends to initiate a PRS-343 combination trial with atezolizumab during the second half of 2018 to interrogate the synergistic potential of 4-1BB agonism and PD-L1 blockade.

PRS-060: Pieris intends to report initial data for its PRS-060 single-ascending dose study in healthy volunteers during the fourth quarter of 2018. PRS-060, the lead candidate in Pieris’ respiratory collaboration with AstraZeneca, is an IL-4 receptor alpha antagonist in development for the treatment of moderate-to-severe asthma. The Company rapidly enrolled the inhaled cohorts of the single-ascending dose study in healthy volunteers and has initiated a multiple-ascending dose study in subjects with mild asthma and elevated levels of fractional exhaled nitric oxide (FeNO). The study will evaluate the safety, tolerability and FeNO-reducing potential of PRS-060 versus placebo. Although Pieris is sponsoring the Phase I trial, AstraZeneca is funding its costs. AstraZeneca will conduct and fund the Phase IIa study, after which Pieris will have separate options to co-develop and co-commercialize the drug candidate.

PRS-080: Pieris intends to report, by year end, pharmacokinetic, safety, tolerability and pharmacodynamic data for its PRS-080 Phase IIa study for the treatment of dialysis-dependent patients with functional iron deficiency anemia, including changes in hemoglobin levels after five weekly doses of PRS-080. ASKA Pharmaceutical Co. currently has an exclusive option for PRS-080 for Japan and other Asian territories, and Pieris will seek to partner the asset outside of those territories if data are positive.

AstraZeneca Collaboration: Pieris recently initiated an additional program on an undisclosed respiratory target as part of its collaboration with AstraZeneca. The collaboration was signed in 2017 and covers the development of PRS-060 and four additional inhalable novel Anticalin proteins against undisclosed targets for respiratory diseases. As part of the collaboration, Pieris has separate co-development and co-commercialization options for PRS-060 and two of the four additional programs.

Servier Collaboration: Pieris continues to work closely with Servier on the development of several bispecific candidates as part of an immuno-oncology collaboration the companies signed in 2017 and anticipates filing the first IND under the collaboration in 2019 for a program for which Pieris retains the option to full U.S. rights.

Seattle Genetics Collaboration: Pieris has initiated work under its collaboration with Seattle Genetics, signed earlier this year, and has generated multiple functionally characterized bispecific antibody-Anticalin fusion proteins for the first program. Under the terms of the collaboration, the companies will pursue the development of three bispecific therapeutics programs assembled from Pieris’ suite of costim-engaging Anticalin proteins and Seattle Genetics’ substantial tumor-targeted antibody portfolio. Pieris may opt into global co-development and U.S. commercialization of one program and share in global costs and profits on a 50/50 basis.

Roche Collaboration: Pieris recently received notification of Roche’s intent to discontinue the companies’ research collaboration and license agreement, effective August 21, 2018. The Roche collaboration, signed in 2015, pursued the discovery of Anticalin proteins specific for an exploratory immuno-oncology target selected by Roche. Pieris received an upfront payment of approximately $6.4M for the collaboration. Anticalin proteins generated under the collaboration will be wholly owned by the Company; Pieris is currently reviewing the data generated under this collaboration and will consider its strategic options thereafter.

Sanofi Collaboration: Pieris recently received notification of Sanofi’s intent to return to Pieris all rights to the tetraspecific Anticalin program targeting P. aeruginosa, effective August 23, 2018. The program originated from a 2010 collaboration from which Pieris received an upfront payment of €3.5M and three milestone payments totaling €1.2M. Sanofi will transfer all related materials, data, and reports to Pieris, who will gain full control over the program. Pieris intends to review this data package and consider its strategic options thereafter.

Early Stage Pipeline: Pieris remains committed to advancing several early stage programs into the clinic and is on track to file two immuno-oncology INDs, one proprietary and one as part of its collaboration with Servier, in 2019. The Company has also initiated two proprietary respiratory programs.
Second Quarter Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $151.7 million as of June 30, 2018, compared to a cash, cash equivalents and investments balance of $82.6 million as of December 31, 2017. The increase was driven primarily by the $47.2 million in net proceeds from the Company’s February 2018 equity financing, the $30.0 million in upfront payments received as part of the Seattle Genetics immuno-oncology collaboration, and the $12.5 million milestone payment from AstraZeneca that was triggered during the fourth quarter of 2017 and received during the first quarter of 2018. The increase was partially offset by $22.2 million of operating cash expenditures during the year.

R&D Expense – R&D expenses were $9.2 million for the three months ended June 30, 2018, compared to $5.4 million for the three months ended June 30, 2017. R&D expenses were $17.1 million for the six months ended June 30, 2018, compared to $10.8 million for the six months ended June 30, 2017. The Company’s increase in R&D expenses reflects advancement across its pipeline of programs as well as preparation for and advancement of clinical studies.

G&A Expense – G&A expenses were $4.8 million for the three months ended June 30, 2018, compared to $4.3 million for the three months ended June 30, 2017. G&A expenses were $9.1 million for the six months ended June 30, 2018, compared to $8.3 million for the six months ended June 30, 2017. The Company’s increase in G&A expenses reflects higher personnel costs, professional services costs for audit and legal, as well as an increase in general administrative costs to support the growing business of the Company. The increase was partially offset by lower transaction fees for license and collaboration agreements compared to amounts recorded in the first half of 2017.

Net Loss – Net loss was $0.2 million or $0.00 per share for the three months ended June 30, 2018, compared to a net loss of $10.1 million or $(0.23) per share for the three months ended June 30, 2017. Net loss was $8.9 million or $(0.17) per share for the six months ended June 30, 2018, compared to a net loss of $18.1 million or $(0.42) per share for the six months ended June 30, 2017.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Daylight Time on Thursday, August 9, 2018, to discuss the first quarter of 2018 financial results and provide a corporate update. You can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On August 9, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a pharmaceutical company focused on the development and commercialization of its proprietary immune modulator, tilsotolimod, for the treatment of cancer, reported that the company will participate in a fireside chat, led by Vincent Milano Idera’s Chief Executive Officer at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14, 2018 at 10:20 a.m. Eastern Time at the Parker Hotel in New York City (Press release, Idera Pharmaceuticals, AUG 9, 2018, View Source [SID1234528704]).

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Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On August 9, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the six-month period ended June 30, 2018 and provided a corporate update (Press release, Protalix, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363036 [SID1234528668]).

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"This has been a fantastic quarter for the company highlighted by the expansion of our partnership with Chiesi that resulted from the strong relationship developed over the past months," commented Moshe Manor, Protalix’s President and Chief Executive Officer. "Additionally, we believe that the recent draft guidelines from the U.S. Food and Drug Administration, or the FDA, released in July regarding enzyme replacement therapies could significantly benefit the regulatory path forward for PRX-102."

2018 Second Quarter and Recent Clinical Highlights

Expanded partnership with Chiesi Farmaceutici S.p.A., or Chiesi, to include exclusive U.S. rights for the development and commercialization of PRX-102. Terms of the agreement include an up-front payment of $25 million, up to $20 million in development costs, up to $760 million, in the aggregate, in regulatory and commercial milestone payments and tiered royalties ranging from 15 to 40%.
In July, the FDA issued a draft guideline "Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies". The draft guideline recognizes the challenges in achieving clinical evidence in rare, slow progressing diseases and provides additional preclinical and clinical results that may be acceptable to the FDA in its consideration for accelerated approval. The Company is reviewing the draft guidelines to determine how they might apply to the Company’s Fabry clinical development program.
With the additional cash from Chiesi, the Company is funded through read-outs of all clinical trials of PRX-102.
Presented data at the Digestive Disease Week (DDW) 2018 Annual Meeting on OPRX-106, which showed mucosal improvement in 61% of patients, mucosal healing in 33% of patients and clinical responses in 67% of patients.
Exchanged 4.50% convertible notes for a combination of shares and cash, and effectively discharged the remainder of the 4.50% notes.
Financial Results for the Six Months ended June 30, 2018

The Company reported a net loss of $20.7 million, or $0.14 per share, basic and diluted for the six-month period ended June 30, 2018 compared to a net loss of $20.6 million, or $0.16 per share, basic and diluted, excluding a one-time, non-cash net charge of $38.1 million in connection with the remeasurement of a derivative, for the same period of 2017.
The Company recorded total revenues of $6.6 million for the six-month period ended June 30, 2018, compared to $9.2 million for the same period of 2017. The decrease is attributed mainly to lower sales of drug substance to Pfizer Inc. and of alfataliglicerase in Brazil.
Research and development expenses were $14.8 million for the six-month period ended June 30, 2018, compared to $15.3 million for the same period of 2017. Chiesi’s participation in the clinical trials of PRX-102 for the treatment of Fabry disease in the amount of $5.0 million was recorded as deferred revenues and not as a deduction from the research and development expenses.
Selling, general and administrative expenses were $4.7 million for the six-month period ended June 30, 2018 compared to $5.4 million for the same period of 2017.
As of June 30, 2018, the Company had $28.3 million of cash and cash equivalents.
Pro forma cash balance for June 30, 2018 to include the upfront from the exclusive license signed with Chiesi for the rights to PRX-102 in the United States is $53.3 million.
Conference Call and Webcast Information

The Company will host a conference call on Thursday, August 9, 2018, at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 9488046.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.