On May 8, 2019 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic" or the "Corporation") reported its unaudited financial results for the first quarter ended March 31, 2019 (Press release, ProMetic Life Sciences, MAY 8, 2019, View Source [SID1234535962]).

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"We are pleased to have completed the recapitalization transactions and equity offering in April that have provided both an improved capital structure and necessary cash liquidity from the $ 75 million gross proceeds received from Structured Alpha LP and Consonance Capital Management", stated Mr. Kenneth Galbraith, Chief Executive Officer. "In addition, the Corporation expects to commence the previously-announced rights offering in the coming weeks, which could provide up to a maximum of $75 million in additional gross proceeds to the Corporation".

"We made excellent progress during the quarter towards completing the necessary development work to permit re-filing of our Ryplazim (plasminogen) ("RyplazimTM ") BLA before the end of 2019. In addition, our bioseparations business had an excellent quarter with revenue growth of 55% compared to the same quarter in 2018."

"We look forward to reporting further progress on our business and R&D activities in the coming months and appreciate the continued support of our shareholders in helping to build a successful and focused global life sciences corporation, with the potential to address unmet medical needs of patients with serious diseases in multiple therapeutic areas of interest", added Mr. Galbraith.

2019 First Quarter Results

Revenues

Total revenues for the quarter ended March 31, 2019 were $8.2 million compared to $4.3 million during the comparative period of 2018 which represents an increase of $3.9 million.

Revenues from the sale of goods were $7.8 million during the quarter ended March 31, 2019 compared to $3.8 million during the corresponding period of 2018, representing an increase of $4.0 million which was due to an increase in the sales of our specialty plasma collected at our plasma collection center in Winnipeg by $1.9 million and the increase of the volume of sales of goods from our Bioseparations segment by $2.1 million compared to the comparative period in 2018.

Cost of sales and other production expenses
Cost of sales and other production expenses were $4.4 million during the quarter ended March 31, 2019 compared to $4.8 million for the corresponding period in 2018, representing a decrease of $0.4 million.

Research and Development ("R&D")
R&D expenses were $19.2 million during the quarter ended March 31, 2019 compared to $22.4 million for the corresponding period in 2018, representing a decrease of $3.2 million.

R&D expenses include the cost to manufacture plasma-derived therapeutics and small molecule therapeutics to be used in clinical trials and for the development of our production processes. The manufacturing and purchase cost of these therapeutics was $9.2 million during the quarter ended March 31, 2019 compared to $7.0 million during the quarter ended March 31, 2018, an increase of $2.2 million.

Other R&D expenses were $10.0 million during the quarter ended March 31, 2019 compared to $15.4 million for the corresponding period in 2018, a decrease of $5.5 million. The decrease is mainly due to the reduction in pre-clinical and clinical trial activity in both the plasma-derived therapeutics and small molecule segments.

Administration, Sales & Marketing
Administration, selling and marketing expenses remained stable at $7.6 million during the quarter ended March 31, 2019 compared to $7.7 million for the corresponding period in 2018 with consulting fees slightly declined offset by employee compensation expense increased.

Finance Costs
Finance costs were $7.4 million for the quarter ended March 31, 2019 compared to $4.2 million during the corresponding period of 2018, representing an increase of $3.1 million. This increase reflects the increased level of debt at higher effective interest rates applied during the quarter ended March 31, 2019 compared to the same period of 2018.

Furthermore, the increase in finance costs are also due to the adoption of the new lease standard, IFRS 16, Leases ("IFRS 16"), under which lease liabilities are recognized for the discounted value of the future lease payments at initial adoption and with interest expense recognized over the term of each lease. The new standard was adopted using the modified retrospective approach and as such, the 2018 figures are not restated. Previously, the embedded interest component in each lease payment was recognized as part of the lease expense included in the various functions presented in the statement of operations such as cost of sales and other production expenses, R&D and administration, selling and marketing. The interest expense over the lease liabilities was $1.8 million in the quarter ended March 31, 2019.

Net Loss
The Corporation incurred a net loss of $28.8 million during the quarter ended March 31, 2019 compared to a net loss of $34.6 million for the corresponding period of 2018, representing a decrease in the net loss of $5.8 million. This is mainly driven by the increase in revenue from sales of goods of $4.0 million, the decrease in R&D of $3.2 million and the increase in the gain of foreign exchange of $2.9 million which is due to a lower USD/CAD exchange rate over the comparative period. This was partially offset by the increase in finance costs expense of $3.1 million in the quarter ended March 31, 2019 compared to the corresponding period in 2018.

Commenting on the 2019 first quarter financial results, Bruce Pritchard, Prometic’s Chief Operating Officer – International and Chief Financial Officer, stated, "Our focus on cost control continues with an improvement in all areas, with the exception of finance costs, over the same quarter of 2018. Clearly, finance costs increased as a result of the increased borrowing required to finance the Corporation in the absence of substantial new equity or business development deals since the first quarter of 2018."

Small Molecule Therapeutics Segment

Q1 2019 Updates:

Following the completion of the review and prioritization of all programs and assets, and completion of refinancing transactions, the main priorities for the small molecule therapeutics segment are:

PBI-4050 – Prometic is planning to file an Investigational New Drug application to enable the commencement of the phase 3 clinical study of PBI-4050 in Alström Syndrome during H2-2019.
PBI-4050 – Prometic is planning a randomized, placebo-controlled phase 2 clinical study of PBI-4050 in patients with Nonalcoholic steatohepatitis ("NASH") to be initiated later in the year, subject to receipt of further financing.
PBI-4050 – Prometic is planning a randomized, placebo-controlled, phase 2 clinical study of PBI-4050 in patients with idiopathic pulmonary fibrosis ("IPF") to be initiated later in the year, subject to receipt of further financing
PBI-4547 – Prometic is planning a phase 1 clinical study to be initiated before the end of 2019.
Plasma-Derived Therapeutics Segment

Q1 2019 Updates:

Following the completion of the review and prioritization of all programs and assets, and completion of refinancing transactions, the main priorities for the plasma-derived therapeutics segment are

RyplazimTM – Refile the BLA for Ryplazim during H2-2019.
RyplazimTM – Conclude ongoing commercialization discussions and secure a strategic transaction with a third party partner for the commercialization of RyplazimTM for global markets.
Corporate and Operational Update

Q1 2019 Updates:

Management and the Board of Directors engaged in a comprehensive strategy to improve the financial and business conditions of the Corporation and, in January 2019, commenced a process to explore and evaluate potential strategic alternatives focused on maximizing shareholder value, including potential acquisitions, joint ventures, strategic alliances, or other merger and acquisition or capital markets transactions as well as any other transaction or alternative available to the Corporation.
In February 2019, the Corporation engaged Lazard, a global financial advisory and asset management firm, to review and execute key strategic transactions focused on maximizing shareholder value. The Corporation has not set a timetable for this process, and there can be no assurance that a transaction will be entered into or consummated, or, if a transaction is undertaken, as to its terms, structure or timing.
In conjunction with the strategic review and liquidity issues faced by the Corporation, in February 2019, the Board of Directors formed a special committee of independent board directors to oversee the strategic review process.
In February and March 2019, the Corporation secured two additional tranches for a total of US$15.0 million from SALP under its existing credit facility with SALP.
During the first quarter of 2019, the Corporation issued 12,870,600 common shares under the ATM for total net cash proceeds of $4.1 million.
Subsequent Events to Q1 2019:

The Corporation announced its intention to enter into a series of related arrangements to restructure Prometic’s outstanding indebtedness, reduce its interest and certain other payment obligations, and raise sufficient cash to build a robust balance sheet for the next phase of Prometic’s development.
The Corporation closed the recapitalization transactions and equity offering previously announced on April 15, 2019. Prometic received $75 million (approximately US$56 million) in gross proceeds from the equity offering led by Consonance Capital Partners and SALP and converted into equity substantially all of its indebtedness to SALP.
The Corporation announced Mr. Kenneth Galbraith as its CEO as well as the appointment of new Board leadership and structure in selecting Mr. Stefan Clulow as Chair of the Board and Prof. Simon Best as Lead Independent Director.
The Corporation implemented a new management structure to provide leadership to the Corporation and announced the appointment of Dr. Gary Bridger, Mr. Tim Wach and Mr. Neil Klompas to the Board of Directors.
Conference Call Information

Prometic will host a conference call at 8:30 am (ET) on Thursday May 9, 2019. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Thursday May 9, 2019 at 11:00 am. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 8892627). A live audio webcast of the conference call, with slides, will be available through the following : View Source

Additional Information in Respect to the First Quarter Ended March 31, 2019

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended March 31, 2019 will be filed on SEDAR (View Source) and will be available on the Corporation’s website at www.prometic.com.

On May 8, 2019 BerGenBio ASA (OSE: BGBIO) reported that it has completed enrolment into the second stage of its Phase II trial (BGBC008, Cohort A NCT03184571) evaluating the Company’s selective AXL inhibitor bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing on or after prior systemic chemotherapy (Press release, BerGenBio, MAY 8, 2019, View Source [SID1234535901]).

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The trial has previously met the efficacy endpoint in the first stage and reported preliminary efficacy including a 40% ORR and 5.9 months Progression-free survival (PFS) in AXL positive patients (n=10). The second stage of the trial enrolling a further 24 patients for a total of 48 is designed to confirm the safety, clinical efficacy and biomarker correlation of the combination.

Comprehensive exploratory studies will continue to evaluate biomarkers in tumour and blood indicative of AXL expression and immune modulation. Results from the trial are expected during 2019.

The trial, which began in October 2017, is being conducted under a clinical collaboration with Merck & Co., Inc., Kenilworth, N.J., USA, through a subsidiary, and is taking place at sites in the US, UK, Norway and Spain.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "A majority of NSCLC patients now receive anti-PD(L)-1 therapies like KEYTRUDA as a first- or second-line treatment for their advanced disease. Enhancing responses to these novel agents, particularly in patients with no or limited expression of PD-L1, the established biomarker for these drugs, is a significant unmet need. I am encouraged by the efficacy signals seen during stage 1 of the trial, particularly in AXL positive, and often PD-L1 negative or low, patients and look forward providing data from an extended dataset during the coming months together with further details on our late stage strategy in this indication."

– End –

About NSCLC
It is estimated that more than 230,000 new cases of lung cancer have been diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.

About the BGBC008 trial
The BGBC008 trial is a Phase II open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated patients with advanced adenocarcinoma of the lung run at centres in the US, UK, Spain and Norway. The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

Patients eligible for participation in Cohort A must have progressed on or after prior therapy excluding immunotherapy whereas patients in Cohort B will be actively progressing on a therapy regimen containing an anti-PD(L)-1 therapy.

Both cohorts follow a two-stage design, Cohort A has previously successfully progressed into the second stage after meeting its first efficacy endpoint. Cohort B will evaluate advancement into stage 2 after 13 patients have been assessed for response.

For more information please access trial NCT03184571 at www.clinicaltrials.gov.

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases. In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body’s immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers. AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities.

On May 8, 2019 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the first quarter ended March 31, 2019 (Press release, Protagonist, MAY 8, 2019, View Source [SID1234535929]). The Company also announced changes to the executive management team, with the appointment of Samuel Saks, M.D., as Chief Medical Officer. In addition, Suneel Gupta, Ph.D., current Executive Vice President of Clinical Operations and Pharmacology, has been promoted to the role of Chief Development Officer.

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"We are pleased to have Dr. Saks expand his involvement with Protagonist as our programs transition to mid-to-late-stage development," commented Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist Therapeutics. "His contributions as Chief Development Officer have been invaluable over the past year as multiple programs have progressed to different stages of development. In addition, we welcome Dr. Gupta to the senior executive team, bringing an abundance of experience across all areas of pharmaceutical product development as our programs continue to mature in the development pipeline. These updates to management serve to broaden and strengthen our clinical development capabilities at a critical inflection point as we move forward with the development of our three clinical candidates, PTG-300, PTG-200 and PN-943. We are pleased to report that we are well financed to support all of our programs through the end of 2020."

In conjunction with the appointment of Dr. Saks to his new role at the Company, Richard Shames, M.D., Chief Medical Officer of Protagonist, will transition to the role of clinical advisor.

Dr. Patel continued, "We are grateful for Dr. Shames’ involvement over the past several years as we have worked together to bring multiple programs from preclinical into clinical development, and are pleased to have him participate as a clinical advisor as we continue to update and expand the management team."

Product Development Update:

PTG-300

· In January, Protagonist announced the initiation of dosing in the Phase 2 TRANSCEND study, a single-arm, open label, global study of injectable hepcidin mimetic PTG-300 in the treatment of patients with transfusion-dependent or non-transfusion dependent beta thalassemia. Preliminary results from this Phase 2 trial are expected in the second half of 2019.

·The Company expects to begin clinical development of PTG-300 in a second indication in the second half of 2019.

PTG-200

·As recently announced, the PTG-200 collaboration agreement with Janssen Biotech has been expanded to include second generation oral IL-23 receptor antagonists, with Protagonist receiving a $25 million milestone payment triggered by the expanded agreement.

· Protagonist and Janssen Biotech are working towards filing a U.S. IND application to support a global Phase 2 clinical study in patients with Crohn’s disease. This IND filing is expected in the second quarter of 2019.

PN-943

· Protagonist announced the initiation of dosing in a Phase 1 study of PN-943, which is being developed as a potential novel oral therapy for patients with inflammatory bowel disease. The study will evaluate safety, pharmacokinetics, and pharmacodynamic readouts of target engagement as measured by blood receptor occupancy in healthy volunteers. Top-line results from this Phase 1 study are expected in the second quarter of 2019.

·The PN-943 Phase 1 data is expected to provide information that will inform the design of a Phase 2 study of PN-943 in patients with ulcerative colitis, with an expected U.S. IND filing in late 2019.

Preclinical research findings describing the properties of PN-943 have been selected for an oral presentation in a Distinguished Abstract Plenary session on Sunday, May 19, 2019, at the Digestive Diseases Week Conference in San Diego.

Financial Results

Protagonist reported a net loss of $14.1 million for the first quarter of 2019, as compared to a net loss of $7.7 million for the same period of 2018. The increase in net loss was driven primarily by a decrease in license and collaboration revenue recognized during the first quarter of 2019. The net loss for the first quarter of 2019 includes non-cash stock-based compensation of $2.0 million, as compared to $1.2 million for the same period of 2018.

License and collaboration revenue, comprised both of revenue recognition relating to the $50 million upfront payment received from Janssen Biotech in 2017 and the services performed under the collaboration agreement, was $1.6 million for the first quarter of 2019 compared to $10.8 million for the same period of 2018. The year over year decrease in license and collaboration revenue is primarily related to the Company approaching, during 2019, the end of the revenue recognition phase of the $50 million upfront payment received from Janssen Biotech in 2017. The Company continued to deliver compound supply services under the Janssen collaboration agreement in the first quarter of 2019.

R&D expenses for the first quarter of 2019 were $12.4 million, which decreased from $15.4 million for the same period of the prior year. The decrease in R&D expenses was primarily due to a decrease in costs on our former development candidate PTG-100 and decreased expenditures related to our shared expenses on PTG-200 under the Janssen collaboration agreement, offset by increased costs related to moving forward our product candidates PTG-300 and PN-943. These R&D costs are primarily related to contract manufacturing and the preparation for and conduct of clinical trials. R&D expenses for the quarter also include an increase in salaries and employee-related expenses due to an increase in stock-based compensation expense.

G&A expenses for the first quarter of 2019 were $3.8 million, as compared to $3.6 million for the same period in the prior year. The increase in G&A expense was due primarily to increases related to supporting the growth of our operations and stock-based compensation expense.

Protagonist ended the first quarter of 2019 with $112.5 million in cash, cash equivalents and investments. Protagonist expects to have sufficient financial resources to fund operations to the end of 2020.

On May 8, 2019 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the first quarter ended March 30, 2019 (Press release, Perrigo Company, MAY 8, 2019, View Source [SID1234535963]).

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Perrigo CEO & President Murray S. Kessler commented, "Perrigo began its transformation from healthcare to consumer self-care during the first quarter of 2019, as the company made meaningful progress on portfolio reconfiguration, accelerating the innovation pipeline, pursuing close-in adjacencies, identifying significant cost savings and strengthening the organization’s talent, processes and performance plans. The leadership team and I are excited to share our Board-approved strategy and the significant progress made during the quarter against that strategy at tomorrow’s Investor Conference. Beyond the company-wide effort to initiate over 40 transformation activities, Perrigo delivered consolidated first quarter results that exceeded our internal target and included approximately $5 million in initial consumer transformation investments. It is also worth noting that our RX division was a significant contributor to this solid start to the year as a result of strong new product activity and continued moderation of pricing pressure in the generics sector."

Kessler continued, "While it will take several years and there is much work to do to fully execute the full consumer self-care transformation, I remain excited and confident in our ability to recapture ‘The Perrigo Advantage’ and bring the Company back to profitable and sustainable growth, as well as reduce the uncertainty that has arisen from the Irish and U.S. tax challenges. The Company will provide 2019 guidance tomorrow morning, before the U.S. market opens, as well as its plans to deliver long-term financial results in-line with our consumer peers."

Reporting Segments Update

The Company updated its reporting segments to align with its self-care strategy. Our Israeli diagnostic business was moved from the Consumer Self-Care International ("CSCI") segment to the RX segment and certain adjustments were made to the Company’s allocations between segments. These updates have no impact on the Company’s historical consolidated financial position, results of operations, or cash flows. A Current Report on Form 8-K containing recast quarterly and annual information for calendar years 2018, 2017, and 2016 for this update will be issued tonight.

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments 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.

Reported net sales for the first quarter of calendar year 2019 were approximately $1.2 billion, including new product sales of $55 million, which were partially offset by less favorable price/volume mix and discontinued products of $23 million. Net sales were down 1% excluding a $36 million negative impact from currency.

Reported net income was $64 million, or $0.47 per diluted share, versus $81 million, or $0.57 per diluted share, in the prior year. Excluding certain charges as outlined in Table I, first quarter 2019 adjusted net income was $146 million, or $1.07 per diluted share including a discrete tax benefit of $0.06 per share, versus $178 million, or $1.26 per diluted share, for the same period last year.

Consumer Self-Care Americas reported net sales were $582 million, or 3.3% lower than the prior year, driven by lower net sales in: 1) the cough and cold and analgesics categories, due to a less severe cough and cold season versus last year, 2) the infant nutrition category, due primarily to lower net sales from the exited infant foods product line (see the "Infant Foods Product line Exit" section below for details) and 3) the animal health business, due primarily to the previously announced loss of a partnered product. Discontinued products in the quarter were $11 million, of which $5 million were related to the animal health business.

Increased net sales in the gastrointestinal category, driven by strong omeprazole volumes compared to the prior year, and new product sales of $7 million partially offset the net sales decline in CSCA. Excluding net sales from the animal health and exited infant foods product line, along with unfavorable currency movements compared to the prior year, CSCA net sales were down 1.5%.

Total sales volume within the CSCA business decreased 1% in the first quarter versus the prior year as higher volumes in the gastrointestinal and allergy categories were more than offset by lower volumes in the cough and cold and analgesics categories.

Based on the most recent 52-weeks MULO data, total OTC retail market dollars grew 0.5% versus the same 52-weeks a year ago, highlighting a more limited new product launch cycle in the U.S. OTC market. Private label grew 1.4% versus national brand growth of 0.1%, according to the most recent 52-weeks MULO data. Growth in private label was driven primarily by the gastrointestinal, allergy and dermatological categories.

First quarter reported gross profit margin was 31.6%. Adjusted gross profit margin was 32.5% or 350 bps lower than the prior year due primarily to less favorable mix, greater operating inefficiencies and higher input costs versus last year.

Reported operating expenses were relatively flat year over year. Reported distribution, selling, general and administrative ("DSG&A") expenses were relatively flat compared to the prior year as greater advertising and promotional expenses versus last year were partially offset by lower distribution costs. R&D dollar investments were similar to the prior year as the Company continued to invest for future growth.

Reported operating margin was 16.2%. Adjusted operating margin was 18.3%, 400 bps lower than the prior year due primarily to adjusted gross margin flow through.

CSCI reported net sales were $351 million, 1.7% higher than the prior year, excluding unfavorable currency movement of $34 million. This segment continued to realize the benefits of the previously discussed portfolio pruning, leaving the core business primed for growth.

Strong new product sales of $26 million were driven primarily by the launch of XLS Forte 5, a next generation weight loss product within the lifestyle category, along with the launch of a natural cough syrup under the Phytosun brand. Additionally, net sales increased in the dermatological category, driven by the recent launch of the Pure Glow range of products under the ACO brand.

These positive drivers were partially offset by lower net sales in the lifestyle and personal care categories, due primarily to new product cannibalization, and the absence of net sales from discontinued products of $2 million.

According to IRI/InQvia (IMS) data, the markets in which the Company competes have produced low to mid-single-digit growth over the last 12 months, with CSCI maintaining its overall market share.

Reported and adjusted gross margin decreased 120 bps and 130 bps respectively, compared to the prior year due primarily to less favorable product mix and the unfavorable impact of foreign currency on input costs versus last year.

Reported operating expenses were lower compared to the prior year due primarily to the positive impact of foreign currency. CSCI growth investments increased on a constant currency basis versus last year as the Company continued to invest for future growth.

Reported operating margin was 2.3%. Adjusted operating margin decreased 190 bps to 15.4% due to gross margin flow through as well as increased advertising and promotion investments as a percentage of net sales partially offset by lower selling expenses versus last year.

RX reported net sales were $242 million in the quarter, or 1.8% higher than the prior year, due primarily to new product sales of $22 million and improved customer service levels. These positives were partially offset by decelerating pricing pressure in core products and discontinued products of $10 million.

Reported gross margin was 39.9%. Adjusted gross margin was 48.6%, or 260 bps lower than the prior year, due primarily to less favorable product mix versus last year.

Reported operating margin was 25.1%. Adjusted operating margin was 33.9%, or 190 bps lower than the prior year due primarily to adjusted gross margin flow through and increased R&D investments, which were partially offset by lower DSG&A expenses versus last year.

Infant Foods Product Line Exit

In 2018, the Company made the decision to exit its infant foods product line, which contributed $34 million to CSCA’s net sales in 2018. The infant foods product line contributed $5 million in net sales during the first quarter of 2019, and the Company does not expect any further contributions from this product line going forward.

Investor Day Event

The Company will hold its Investor Day tomorrow, May 9, 2019, in New York City to discuss its strategy as well as 2019 guidance and key growth opportunities. The event will feature presentations from Murray S. Kessler, CEO and President, and other members of the Company’s leadership team.

The event is scheduled to begin at 8:00 AM EST and will be webcast live. All interested parties are invited to access the event at View Source

On May 8, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has completed its anticipated capital raising of $10,000,005.50 (Press release, Clarity Pharmaceuticals, MAY 8, 2019, View Source [SID1234535879]). This includes the previously announced strategic investment of $5,000,002.75 from GenesisCare, the largest private provider of cancer treatment in Australia and Europe, an additional $3,965,957.00 from the undertaking of a Rights Issue to Clarity’s existing shareholders, and now the remaining amount of $1,034,045.75 from new shareholders.

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The funds will enable Clarity to progress the development of its pipeline of radiopharmaceuticals, including Cu-64 SARTATE and Cu-67 SARTATE, which are next generation, highly targeted, theranostic (diagnostic and therapy) pharmaceuticals with increased specificity and in vivo stability. Clarity’s first theranostic trial of SARTATE in a serious brain cancer called meningioma commenced in July 2018 with the study halfway complete. Clarity will also progress clinical trials with SARTATE in neuroendocrine tumours (NETs) and neuroblastoma in collaboration with leading institutions in the US and Australia. In addition to the development of SARTATE, the capital raising will also enable the clinical development of two other products in Clarity’s pipeline, a prostate specific membrane antigen (PSMA) targeting product for the diagnosis and treatment of prostate cancer; and a bombesin product that targets the gastrin-releasing peptide receptor, which is present in a number of serious cancers including lung, ovarian, prostate, and breast.

Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "We are very pleased to have completed our capital raising which included a strategic investment from our partner GenesisCare, strong support from our current shareholder base as well as great demand from new investors. This capital raising also coincides with recent additions and changes to the team, including ex-Algeta CEO and CMO, Dr Thomas Ramdahl and Dr Gillies O’Bryan-Tear respectively, joining our Board, as well as former Algeta executive, Dr Colin Biggin, moving to acting CEO. Our growing team is dedicated to continuing our important work of developing safer and more effective treatments for children and adults with cancer together with a number of our collaborators and world leading experts in the field."