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.

On August 9, 2018 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that the Company has been selected to present at the prestigious 25th Annual NewsMakers in the Biotech Industry on Friday, September 7th, at 2:00pm, ET, at the Millennium Broadway Hotel and Conference Center in New York (Press release, Propanc, AUG 9, 2018, View Source [SID1234528666]).

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Hosted by BioCentury, only 48 companies are handpicked to present their stories to institutional investors in the Biotech sector. Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

"We are very proud to have been selected by BioCentury to present at NewsMakers in the Biotech Industry. It gives us a great opportunity to convey our story to international investors," said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. "Our focus will be to present the recent advancements of our lead product candidate, PRP, and its effects against cancer stem cells as a way to control metastasis, which is the main cause of patient death from cancer."

PRP is a solution for intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Progressing towards a First-In-Human study, PRP seeks to prevent recurrence and metastasis from solid tumors by targeting and eradicating cancer stem cells. Eighty percent of cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. A report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research

On August 9, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the second quarter ended June 30, 2018 (Press release, Perrigo Company, AUG 9, 2018, View Source [SID1234528664]).

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Additional first half of the year reported results: Reported CHC Americas net sales increased 0.9%. Reported operating margin in the CHC International segment was 2.6%. Reported operating margin in the RX segment was 28.1%.

Perrigo President and CEO, Uwe Roehrhoff commented, "For the first half of calendar year 2018, adjusted EPS performance met our operating goals, driven by the strength of our durable consumer businesses. During the same period, the RX business performed below our expectations and experienced weakness due primarily to a shortfall in new product launches coupled with challenging market dynamics, which is expected to carry forward into the second half of the year. This has resulted in changes to our 2018 operating plan, which are reflected in our updated guidance. I am extremely disappointed in this development and want to reinforce that my primary focus is to create value for shareholders."

Mr. Roehrhoff continued, "Our consumer businesses delivered durable results for the first half of the year. CHC Americas net sales grew approximately 1% on a constant currency basis, while our market-leading OTC and infant nutrition businesses grew approximately 2.5% combined, versus prior year. Adjusted operating margin in the CHC International segment improved to 16.1% for the first half of year, or a 190 basis point improvement compared to the prior year. First half net sales in the RX segment were lower than the prior year by 8% due to challenging market dynamics. Despite the delay in key new product launches in the RX segment, its adjusted operating margin for the first half of 2018 was approximately 40%. Finally, we utilized our strong balance sheet to repurchase approximately $265 million dollars of shares in the first half of 2018."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Second Quarter Results

Reported net sales for the second quarter of calendar year 2018 were approximately $1.2 billion, which included new product sales of $42 million and the absence of sales from discontinued products of $17 million. Net sales decreased 4.0% compared to the prior year excluding the year-over-year effect of: 1) $7 million in net sales from the exited Russian and unprofitable distribution businesses in 2017 in the CHC International segment, 2) net sales from the divested Israel API business of $16 million and 3) favorable foreign currency movements of $19 million.

Reported net income was $36 million, or $0.26 per diluted share, versus net loss of $70 million, or $0.49 per diluted share, in the prior year. Excluding charges as outlined in Table I, second quarter 2018 adjusted net income was $169 million, or $1.22 per diluted share, versus adjusted net income of $175 million, or $1.22 per diluted share, for the same period last year.

Segment Results

Second quarter reported net sales decreased 1.2% on a constant currency basis due primarily to lower net sales in the animal health business compared to the prior year. Strong net sales in the cough/cold/allergy/sinus category and infant formula business, coupled with new product sales of $15 million, were partially offset by lower net sales in the smoking cessation category and discontinued products of $4 million.

CHC Americas second quarter reported gross profit margin was 32.7%. Adjusted gross profit margin was 34.5%, 120 basis points lower than the prior year due primarily to lower net sales the animal health business and higher input costs.

Reported second quarter operating margin was 9.6%. Second quarter adjusted operating margin was 20.4%, 60 basis points lower than the prior year as gross margin flow through was offset by proactive cost management efforts.

Reported net sales increased 1.2% compared to the second quarter of 2017. Excluding $7 million in net sales from the exited Russian and unprofitable distribution businesses in 2017, and favorable foreign currency movements of $20 million, net sales decreased 2.2% due primarily to lower sales in the anti-parasite, lifestyle and analgesics categories in addition to discontinued products of $8 million. Partially offsetting these effects were new product sales of $19 million and higher net sales in the diagnostics business.

Second quarter reported gross margin was 47.5%. Adjusted gross margin increased 160 basis points over the previous year to 53.3%, driven by improved product mix, new product launches and the continued benefit of insourcing initiatives.

Reported operating margin was 1.5%. Adjusted operating margin expanded 60 basis points to 15.2% due to higher gross margin contribution, partially offset by higher growth investments in the quarter compared to the prior year.

Reported net sales in the second quarter were $209 million compared to $240 million last year. New product sales of $8 million were more than offset by lower net sales of existing products of $35 million, due primarily to price erosion. Discontinued products were $5 million.

Reported gross margin was 45.3%. Adjusted gross margin was 55.1%, 370 basis points lower than the same quarter last year, due to strong product mix in 2017.

Reported operating margin was 27.3%. Adjusted operating margin was 39.4% compared to 46.5% in the prior year, due primarily to gross margin flow through and higher R&D investments as a percentage of net sales.

Guidance

The Company now expects calendar year 2018 reported operating income to be in the range of $548 million to $578 million, reported effective tax rate to be approximately 25.0%, and reported diluted EPS to be in the range of $2.11 to $2.31.

Primarily due to revised expectations for the RX segment and unfavorable foreign currency translation of $65 million, the Company now expects calendar year 2018 net sales to be in the range of $4.8 billion to $4.9 billion. The Company further expects adjusted operating income in the range of $960 million to $990 million, an adjusted effective tax rate of approximately 20.0% and an adjusted diluted EPS range of $4.75 to $4.95.

Conference Call

The Company will host a conference call at 8:30 a.m. EDT (5:30 a.m. PDT), August 9, 2018. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 877-870-4263, International 412-317-0790, and reference ID #2297446. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Thursday, August 9, until midnight August 24, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10122783.