On February 21, 2018 The Medicines Company (NASDAQ:MDCO) today reported its financial results for the fourth quarter and full year ended December 31, 2017 (Press release, Medicines Company, FEB 21, 2018, View Source;p=RssLanding&cat=news&id=2333597 [SID1234524083]).

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"We have successfully executed our strategic action plan for 2017 by divesting our non-core assets, restructuring our business to focus on inclisiran, and initiating the inclisiran Phase 3 ORION program – recently completing target enrollment ahead of schedule in both ORION 11 and ORION 9 trials," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company.

Dr. Meanwell continued, "We expect momentum to continue throughout 2018, including rapid accrual of clinical safety information on inclisiran and manufacturing development. Based on this accelerated and efficient progress, we believe an NDA and MAA submission will be feasible as soon as the second half of 2019."

Fourth-Quarter 2017 Financial Summary from Continuing Operations

Worldwide net revenue was $8.6 million in the fourth-quarter of 2017 compared to $17.4 million in the fourth-quarter of 2016, primarily from Angiomax, including both royalty revenues derived from the gross profit on authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. and worldwide Angiomax/Angiox (bivalirudin) net product sales. The fourth quarter of 2016 also included $0.4 million of sales related to the divested non-core cardiovascular products.

On a GAAP basis, loss from continuing operations in the fourth quarter of 2017 was $159.4 million, or $2.19 per share, compared to $82.8 million, or $1.17 per share, in the fourth quarter of 2016. Included in loss from continuing operations for the fourth quarter of 2017 were charges of approximately $63.0 million for the impairment of the contingent purchase price for Raplixa, $20.0 million milestone for the first dosing in phase III inclisiran study and $15.0 million in connection with an obsolescence inventory reserve for Angiomax. On a non-GAAP basis, adjusted loss(1) from continuing operations in the fourth quarter of 2017 was $44.4 million, or $0.61(1) per share, compared to $54.9 million, or $0.78(1) per share, in the fourth quarter of 2016.

Fourth-Quarter 2017 Financial Summary from Discontinued Operations

In the fourth quarter of 2017 the Company entered into a definitive agreement to sell its infectious disease business unit to Melinta Therapeutics, Inc. for $270 million in upfront consideration and guaranteed payments ($215 million of guaranteed cash and $55 million of Melinta common stock), tiered royalty payments of 5% to 25% on worldwide net sales of Vabomere, Orbactiv and Minocin IV, and the assumption by Melinta of all royalty, milestone and other payment obligations relating to those products.

In the first quarter of 2016, the Company completed the divestiture of its hemostasis products for an upfront payment of $174.1 million, and potential milestone payments of up to an additional $235.0 million, in the aggregate, following the achievement of certain specified net sales milestones.

Net loss from discontinued operations in the fourth quarter of 2017 was $18.8 million compared to $40.1 million in 2016.

Full-Year 2017 Financial Summary from Continuing Operations

Worldwide net revenue was $44.8 million for the full year 2017 compared to $143.2 million in 2016. Included in total net revenue for the full year 2017 and 2016 was $44.6 million and $104.9 million, respectively, of Angiomax revenue, including both royalty revenues derived from the gross profit on authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. and worldwide Angiomax/Angiox (bivalirudin) net product sales.

On a GAAP basis, loss from continuing operations for the full year 2017 was $607.7 million, or $8.40 per share, compared to income from continuing operations of $20.5 million, or $0.28 per share, for the full year 2016. Included in net loss from continuing operations for 2017 were net charges of approximately $277.0 million associated with the discontinuation and market withdrawal of Ionsys (fentanyl iontophoretic transdermal system) in the U.S. market, $63.0 million for the impairment of the contingent purchase price of Raplixa, $27.3 million associated with the discontinuation of the clinical development program for MDCO-700, our investigational anesthetic agent, and $20.0 million milestone for the first dosing in the phase III inclisiran study. On a non-GAAP basis, adjusted loss(1) from continuing operations for the full year 2017 was $142.4 million, or $1.97(1) per share, compared to $169.0 million, or $2.42(1) per share, for the full year 2016.

(1) Adjusted net loss and adjusted loss per share from continuing operations are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the "Non-GAAP Financial Performance Measures" and "Reconciliations of GAAP to Adjusted Loss From Continuing Operations and Adjusted Loss per Share" sections of this press release.

Full-Year 2017 Financial Summary from Discontinued Operations

Net loss from discontinued operations for the full year 2017 was $100.7 million or $1.39 per share, compared to $139.7 million, or $1.91 per share in 2016.

At December 31, 2017, the Company had a total of $151.4 million in cash and cash equivalents.

Fourth-Quarter 2017 Conference Call and Webcast Information

The Company will host a conference call and webcast today, February 21, 2018, at 8:30 a.m., Eastern Daylight Time, to discuss its fourth-quarter 2017 financial results and provide clinical and operational updates. The dial-in information to access the call is as follows:

U.S./Canada: (877) 359-9508
International: (224) 357-2393
Conference ID: 3592738

A taped replay of the conference call will be available from 11:30 a.m., Eastern Daylight Time, today until 11:30 a.m., Eastern Daylight Time, on February 28, 2018. The replay may be accessed as follows:

U.S./Canada: (855) 859-2056
International: (404) 537-3406
Conference ID: 3592738

The webcast can be accessed in the Investors section of The Medicines Company website. A replay of the webcast will also be available.

About Inclisiran

Inclisiran (formerly known as PCSK9si and ALN-PCSsc) is an investigational GalNAc-conjugated RNAi therapeutic targeting PCSK9 – a genetically validated protein regulator of LDL receptor metabolism – being developed for the treatment of hypercholesterolemia. In contrast to anti-PCSK9 monoclonal antibodies (MAbs) that bind to PCSK9 in blood, inclisiran is a first-in-class investigational medicine that acts by turning off PCSK9 synthesis in the liver.

The Medicines Company and Alnylam Pharmaceuticals, Inc. are collaborating in the advancement of inclisiran pursuant to their 2013 agreement. Under the terms of the agreement, Alnylam completed certain pre-clinical studies and the Phase I clinical study, with The Medicines Company leading and funding the development of inclisiran from Phase II forward, as well as potential commercialization.

On February 21, 2018 United Therapeutics Corporation (NASDAQ: UTHR) reported its financial results for the fourth quarter and year ended December 31, 2017 (Press release, United Therapeutics, FEB 21, 2018, View Source [SID1234524084]).

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"Our fourth quarter net revenues reached $465 million and our annual net revenues reached $1.7 billion, our highest quarterly and annual net revenues ever," said Martine Rothblatt, Ph.D., United Therapeutics Chairman and Chief Executive Officer. "Orenitram’s fourth quarter net revenues grew by 25%, as compared to the same period in the prior year, representing our third consecutive quarter of greater than 20% net revenue growth for this therapy and confirming our belief in the organic growth opportunity for Orenitram, which is the only true oral prostacyclin analogue therapy for the large and increasing number of pulmonary arterial hypertension (PAH) patients. These financial results strengthen our ability to develop and advance our growing product pipeline, which currently includes seven phase III programs and multiple next-generation treprostinil drug delivery systems as well as investigative regenerative medicine and organ manufacturing programs, which we hope will ultimately provide a cure for PAH and other end-stage organ diseases."

Key financial highlights include (in millions, except per share data):

Three Months Ended
December 31,

Year Ended
December 31,

2017

2016

2017

2016

Revenues

$

464.7

$

409.0

$

1,725.3

$

1,598.8

Net income

$

19.0

$

110.3

$

417.9

$

713.7

Non-GAAP earnings(1)

$

170.2

$

184.3

$

741.3

$

726.0

Net income, per diluted share

$

0.43

$

2.43

$

9.31

$

15.25

Non-GAAP earnings, per diluted share(1)

$

3.89

$

4.06

$

16.51

$

15.51

(1) See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below.

Revenues

The table below summarizes the components of total revenues (dollars in millions):

Three Months Ended
December 31,

Percentage

Year Ended
December 31,

Percentage

2017

2016

Change

2017

2016

Change

Net product sales:

Remodulin

$

180.1

$

151.2

19.1

%

$

670.9

$

602.3

11.4

%

Tyvaso

92.4

93.6

(1.3

)%

372.9

404.6

(7.8

)%

Adcirca

119.3

112.7

5.9

%

419.7

372.2

12.8

%

Orenitram

48.0

38.3

25.3

%

185.8

157.2

18.2

%

Unituxin

24.9

13.2

88.6

%

76.0

62.5

21.6

%

Total revenues

$

464.7

$

409.0

13.6

%

$

1,725.3

$

1,598.8

7.9

%

1

Revenues for the quarter ended December 31, 2017 increased by $55.7 million as compared to the same period in 2016. The growth in revenues primarily resulted from: (1) a $28.9 million increase in Remodulin net product sales; (2) an $11.7 million increase in Unituxin net product sales; (3) a $9.7 million increase in Orenitram net product sales; and (4) a $6.6 million increase in Adcirca net product sales, partially offset by a $1.2 million decrease in Tyvaso net product sales.

Revenues for the year ended December 31, 2017 increased by $126.5 million as compared to the same period in 2016. The growth in revenues primarily resulted from the following: (1) a $68.6 million increase in Remodulin net product sales; (2) a $47.5 million increase in Adcirca net product sales; (3) a $28.6 million increase in Orenitram net product sales; and (4) a $13.5 million increase in Unituxin net product sales, partially offset by a $31.7 million decrease in Tyvaso net product sales.

Expenses

Cost of product sales. The table below summarizes cost of product sales by major category (dollars in millions):

Three Months Ended
December 31,

Percentage

Year Ended
December 31,

Percentage

2017

2016

Change

2017

2016

Change

Category:

Cost of product sales

$

46.7

$

19.5

139.5

%

$

103.1

$

72.1

43.0

%

Share-based compensation expense(1)

6.3

8.9

(29.2

)%

2.6

0.6

333.3

%

Total cost of product sales

$

53.0

$

28.4

86.6

%

$

105.7

$

72.7

45.4

%

(1) Refer to Share-based compensation expense below for discussion.

Cost of product sales, excluding share-based compensation. The increases in cost of product sales of $27.2 million and $31.0 million, respectively, for the quarter and year ended December 31, 2017 as compared to the same periods in 2016, were primarily attributable to a $21.9 million increase in royalty expense for Adcirca. Our amended license agreement with Eli Lilly and Company resulted in our royalty rate on net product sales of Adcirca increasing from five percent to an effective rate of approximately 42.5 percent beginning December 1, 2017. The remaining increase in cost of product sales was primarily attributable to an increase in sales.

Research and development expense. The table below summarizes research and development expense by major category (dollars in millions):

Three Months Ended
December 31,

Percentage

Year Ended
December 31,

Percentage

2017

2016

Change

2017

2016

Change

Project and non-project:

Research and development expense

$

91.5

$

46.6

96.4

%

$

256.4

$

157.6

62.7

%

Share-based compensation expense (benefit)(1)

22.1

20.3

8.9

%

8.2

(10.0

)

182.0

%

Total research and development expense

$

113.6

$

66.9

69.8

%

$

264.6

$

147.6

79.3

%

(1) Refer to Share-based compensation expense below for discussion.

Research and development expense, excluding share-based compensation. The increases in research and development expense of $44.9 million and $98.8 million, respectively, for the quarter and year ended December 31, 2017 as compared to the same periods in 2016, were driven by the expansion of our pipeline programs to treat cardiopulmonary disease and cancer and to develop organ manufacturing technologies.

2

Selling, general and administrative expense. The table below summarizes selling, general and administrative expense by major category (dollars in millions):

Three Months Ended
December 31,

Percentage

Year Ended
December 31,

Percentage

2017

2016

Change

2017

2016

Change

Category:

General and administrative

$

51.4

$

45.9

12.0

%

$

203.1

$

210.7

(3.6

)%

Sales and marketing

17.6

17.5

0.6

%

64.3

84.6

(24.0

)%

Share-based compensation expense(1)

90.1

76.1

18.4

%

62.7

21.5

191.6

%

Total selling, general and administrative expense

$

159.1

$

139.5

14.1

%

$

330.1

$

316.8

4.2

%

(1) Refer to Share-based compensation expense below for discussion.

General and administrative, excluding share-based compensation. The decrease in general and administrative expenses of $7.6 million for the year ended December 31, 2017, as compared to the same period in 2016, primarily resulted from: (1) a $32.0 million decrease in grants to non-affiliated, non-profit organizations that provide financial assistance to patients with PAH; and (2) a $9.3 million decrease of expenses in connection with the disposition and write down of various properties in 2016. The decrease was partially offset by: (1) a $9.4 million increase in legal fees incurred in connection with intellectual property litigation and the Department of Justice (DOJ) investigation of our support of 501(c)(3) organizations that provide financial assistance to patients; (2) a $9.2 million increase in compensation due to an increase in staffing; and (3) a $6.5 million increase in consulting expenses.

Sales and marketing, excluding share-based compensation. The decrease in sales and marketing expenses of $20.3 million for the year ended December 31, 2017, as compared to the same period in 2016, primarily resulted from a $11.3 million decrease in compensation and related costs associated with the 2016 consolidation of our sales and marketing staff.

Share-based compensation expense. The table below summarizes share-based compensation expense (benefit) by major category (dollars in millions):

Three Months Ended
December 31,

Percentage

Year Ended
December 31,

Percentage

2017

2016

Change

2017

2016

Change

Category:

Stock options

$

13.1

$

3.1

322.6

%

$

43.0

$

24.8

73.4

%

Share tracking awards plan

104.6

101.3

3.3

%

27.1

(15.2

)

278.3

%

Other(1)

0.8

0.9

(11.1

)%

3.4

2.5

36.0

%

Total share-based compensation expense

$

118.5

$

105.3

12.5

%

$

73.5

$

12.1

507.4

%

(1) Includes expense related to restricted stock units and our employee stock purchase plan for the periods ended December 31, 2017 and 2016.

Share-based compensation. The increase in share-based compensation expense of $13.2 million during the quarter ended December 31, 2017, as compared to the same period in 2016, was primarily due to a $10.0 million increase in stock option expense due to additional awards outstanding in 2017.

The increase in share-based compensation expense of $61.4 million during the year ended December 31, 2017, as compared to the same period in 2016, was primarily due to: (1) a $42.3 million increase in share tracking awards expense related to an increase in our stock price during 2017 and the continued vesting of outstanding awards; and (2) an $18.2 million increase in stock option expense due to additional awards granted and outstanding in 2017.

Settlement of Loss Contingency

In December 2017, we entered into a civil Settlement Agreement with the U.S. Government to resolve a DOJ investigation related to our support of 501(c)(3) organizations that provide financial assistance to patients. During the second quarter of 2017, we recorded a $210.0 million accrual relating to this matter, and ultimately paid this amount, plus interest, to the U.S. Government upon settlement. This matter is described in more detail in Note 16—Litigation—Department of Justice Subpoena, to our consolidated financial statements included within our Annual Report on Form 10-K for the year ended December 31, 2017.

Impairment of Cost Method Investment

During the year ended December 31, 2017, we recorded $49.6 million of impairment charges related to our cost method investments in privately-held companies. There were no such impairment charges in the year ended December 31, 2016.

3

Income Taxes

The provision for income taxes was $351.6 million for the year ended December 31, 2017, compared to $346.5 million for the same period in 2016. The change in the provision for income taxes was primarily due to a charge for the revaluation of deferred taxes due to the lower corporate tax rate enacted by The Tax Cuts and Jobs Act ("Tax Reform"), which is effective as of January 1, 2018, and increases in nondeductible items, partially offset by a decrease in income before income taxes. For the years ended December 31, 2017 and 2016, the effective tax rates were approximately 46 percent and 33 percent, respectively.

Non-GAAP Earnings

Non-GAAP earnings is defined as net income, adjusted for: (1) share-based compensation expense (including expenses relating to stock options, restricted stock units, share tracking awards, and our employee stock purchase plan); (2) settlement of loss contingency; (3) impairment charges; (4) impact of Tax Reform; and (5) tax impact on non-GAAP earnings adjustments.

A reconciliation of net income to non-GAAP earnings is presented below (in millions, except per share data):

Three Months Ended
December 31,

Year Ended December 31,

2017

2016 (1)

2017

2016 (1)

Net income, as reported

$

19.0

$

110.3

$

417.9

$

713.7

Adjust for the following charges:

Share-based compensation expense(2)

118.5

105.3

73.5

12.1

Settlement of loss contingency(3)

—

—

210.0

—

Impairment of cost method investments(4)

—

—

49.6

—

Other impairment charges(4)

—

4.3

—

4.3

Impact of Tax Reform(5)

71.0

—

71.0

—

Tax benefit(2)(3)

(38.3

)

(35.6

)

(80.7

)

(4.1

)

Non-GAAP earnings

$

170.2

$

184.3

$

741.3

$

726.0

Non-GAAP earnings per share:

Basic

$

3.94

$

4.37

$

16.85

$

16.58

Diluted

$

3.89

$

4.06

$

16.51

$

15.51

Weighted average number of common shares outstanding:

Basic

43.2

42.2

44.0

43.8

Diluted

43.8

45.4

44.9

46.8

(1) We changed the presentation of our non-GAAP earnings in the first quarter of 2017 to exclude adjustments for interest expense and depreciation and amortization. Prior year periods have been conformed to match the current year presentation.

(2) We calculated the total tax impact of non-discrete quarterly non-GAAP earnings adjustments based on our annual effective tax rates, before considering discrete items, of approximately 32 percent and approximately 34 percent for each of the quarters and years ended December 31, 2017 and 2016, respectively.

(3) The tax benefit for the year ended December 31, 2017 includes $57.0 million of benefit for the estimated loss contingency recognized during the second quarter of 2017 relating to the DOJ investigation of our support of 501(c)(3) organizations that provide financial assistance to patients.

(4) This non-GAAP earnings adjustment is currently not considered tax deductible.

(5) The impact of Tax Reform is a significant and unusual component of tax expense, therefore in the calculation of non-GAAP earnings, it is presented separately from the tax benefit that is derived from the other non-GAAP adjustments.

4

Conference Call

We will host a half-hour teleconference on Wednesday, February 21, 2018, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406 and using access code 2296917.

This teleconference is also being webcast and can be accessed via our website at View Source

On February 21, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic") reported an update regarding its clinical development programs and confirmation of its priorities regarding its lead drug candidates (Press release, ProMetic Life Sciences, FEB 21, 2018, View Source [SID1234524104]).

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PBI-4050 And Follow-On Analogs, PBI-4547 & PBI-4425
"Idiopathic pulmonary fibrosis (IPF) is now priority No.1 for PBI-4050" stated Pierre Laurin, President and CEO of Prometic. "IPF remains to this day a significant unmet medical need affecting hundreds of thousands of patients with an established market value measured in $billions. The clinical efficacy demonstrated so far in multiple phase 2 clinical trials combined with an impressive safety and tolerability profile gives us great confidence in PBI-4050’s ability to efficiently address fibrotic diseases."

Following the outcome of the successful clinical development Type C meeting held with the FDA in early January 2018, the top clinical development program priority is now the phase 3 pivotal clinical trial for PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF). The all comers study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV) or not and will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication for the treatment of IPF. This multinational study, involving multiple sites across the United States, Canada, Australia, the UK and Europe is expected to begin patient enrollment around the 2018 mid-year mark.

Following last year’s confirmation that beneficial clinical effects are sustained during prolonged treatment in subjects suffering from Alström Syndrome in the United Kingdom, further extensions of duration of treatment were announced to Prometic’s on-going phase 2 open label clinical trial. Prometic now announces that it is formally seeking meetings with both the European and the US regulatory authorities to determine the clinical- regulatory pathway for this condition as a stand-alone indication.

Pierre Laurin stated: "We will soon be disclosing further clinical data from the on-going Alström Syndrome clinical trial in the UK which also gives us great confidence to pursue this devastating condition as a stand-alone fibrosis indication to be treated with PBI-4050. Safety and efficacy data collected and demonstrated to date in such a challenging patient population will also contribute to the clinical design and potential treatment for future clinical development initiatives of the Corporation with respect to indications such as heart, kidney & liver fibrosis".

As part of this realignment, the Corporation has terminated PBI-4050 clinical trial in Cystic Fibrosis Related Diabetes ("CFRD") and is evaluating the need to continue other on-going clinical programs with PBI-4050. Prometic is evaluating its clinical development strategy regarding follow-on compounds (i.e. analogs of PBI-4050) which share the same unique mechanism of action with PBI-4050, have demonstrated similar performance in multiple preclinical studies and some of which have outperformed PBI-4050 in specific animal models. Clinical development of those analogs would enable Prometic to target other fibrotic-related indications and create further therapeutic products optionality for our on- going partnering discussions.

These realignments therefore include: The commencing of PBI-4547’s clinical program includes the initiation of the phase 1 clinical trial in Q2 2018 followed by a phase 2 in patients with liver fibrosis and metabolic diseases. It further includes the initiation of PBI- 4425’s clinical program which is scheduled to commence in H2 2018 with specific targeted indications to be communicated in H2 2018.

RyplazimTM For Plasminogen Deficiencies
RyplazimTM (plasminogen) is the first biopharmaceutical expected to be launched commercially pending the review of its BLA (Biologic License Application) submitted to the FDA initially for the treatment of congenital plasminogen deficiency.

The Company will prioritize the expansion of clinical indications for RyplazimTM and leverage the positive clinical experience gained by supplementing plasminogen levels in deficient patients. There are several medical conditions, some of which potentially lethal, associated with "acquired plasminogen deficiencies" and Prometic is designing clinical trials to establish optimal dosing protocols for the potential use of RyplazimTM for the treatment of such conditions, including thrombotic events as well as acute exacerbations in patients with acute respiratory distress syndrome (ARDS) and/or IPF.

Clinical trials with sub-cutaneous Plasminogen in patients with diabetic foot ulcers and in patients with Tympanic perforations are also currently being conducted in Sweden with expected interim clinical data readouts later this year.

The expenses related to the IVIG non-inferiority phase 3 clinical trial will decrease in 2018 with the completion in H1 2018 of the adults’ cohort required for the FDA BLA filing to be followed by the completion of the pediatric cohort in H1 2019.

Commenting on the financing strategy required to execute on these plans, Bruce Pritchard, Prometic’s CFO noted, "At this stage in its development, the Corporation requires a financing strategy that allows it to maintain adequate capitalization as it continues to build enterprise value with its strong pipeline of therapeutics, but that also recognizes the need for a combination of: generating revenue through product sales; generating revenue from leveraging the asset base, such as licensing technologies for non-core indications or geographies and monetizing priority review vouchers; effective use of debt and synthetic royalty structures and by accessing capital from long-term institutional investors under the best possible conditions". He added, "Each element of this plan is critical, and is being actively pursued by management. Investors should be assured that no single component of the strategy is been seen as mutually exclusive to another. Most importantly, all components need to be readily deployable as required, as we continue to plan to execute a timely secondary listing on NASDAQ".

To maintain its flexibility for strategic fund-raising, Prometic has filed a preliminary short form base shelf prospectus (the "Preliminary Shelf Prospectus") with the securities commissions in each of the provinces of Canada.

Mr. Pritchard went on to explain, "The establishment of a shelf prospectus is common practice among our Canadian and US Peers. Prometic is somewhat unusual for not having one in place. Today’s filing of such a shelf prospectus adds to our armory of financing choices".

The Preliminary Shelf Prospectus, when made final or effective, will allow Prometic to offer up to $250,000,000 of common shares over the 25-month period that the Shelf Prospectus is effective. The Shelf Prospectus will enable Prometic to potentially access new capital as and when needed. The amount and timing of any future offerings will be based on the Company’s financial requirements and market conditions at the time. The specific terms of any future offering under the Shelf Prospectus will be established at the time of such offering. At the time any of the securities covered by the Shelf Prospectus are offered for sale, a prospectus supplement containing specific information about the terms of such offering will be filed with applicable Canadian securities regulatory authorities. The Preliminary Shelf Prospectus filed today with the Canadian securities regulatory authorities has not yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the Preliminary Shelf Prospectus becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction. A copy of the Preliminary Shelf Prospectus can be found on SEDAR at www.sedar.com or may be obtained upon request to Prometic’s Investor Relations Department using the contact information set out below.

On February 21, 2018 Advaxis presented Investor Presentation (Presentation, Advaxis, FEB 21, 2018, View Source [SID1234524088]).

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On February 21, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the publication of the results from the Phase 1 first-in-human study of umbralisib (TGR-1202), the Company’s novel once-daily PI3K delta inhibitor, in The Lancet Oncology (Press release, TG Therapeutics, FEB 21, 2018, View Source [SID1234524106]). The paper includes safety and efficacy information from 90 patients with relapsed or refractory b-cell malignancies, including patients with Chronic Lymphocytic Leukemia (CLL) and various forms of lymphoma treated with single agent umbralisib. In this study, umbralisib was well tolerated with a favorable safety profile distinct from prior generation PI3K delta inhibitors. Grade 3/4 immune mediated AEs commonly associated with other PI3K delta inhibitors were limited, with transaminitis occurring in 3 patients ( < 3%), and pneumonia and colitis in 2 patients each ( < 2% for each). Notably, both events of colitis occurred at doses exceeding the current Phase 3 dose. Umbralisib was also clinically active with 85% of relapsed or refractory CLL patients achieving an objective response (50% per IWCLL criteria; 35% a partial response with lymphocytosis) and 53% of patients with relapsed or refractory Follicular Lymphoma (FL) achieving an objective response, including 2 patients with a Complete Response (CR).

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These data, in addition to the unique structural attributes and enhanced selectivity profile of umbralisib, are described further in the manuscript entitled, "Umbralisib, a novel PI3K and casein kinase-1 epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study," which was published yesterday in The Lancet Oncology. The online version of the article can be accessed at http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30082-2/fulltext.

Dr. Howard A. Burris, the Chief Medical Officer and Executive Director of the Drug Development Program at the Sarah Cannon Research Institute in Nashville, TN, and lead author stated, "We are pleased to have treated the first patient ever with umbralisib over 5 years ago and believe it has an important place in the treatment landscape for patients with hematologic malignancies. Several patients from this Phase 1 study are still on study today, approaching 5 years of continuous daily therapy, speaking to both the safety and efficacy profile of this unique agent."

Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center, stated, "Pre-clinically umbralisib has a very unique profile, selectively inhibiting both PI3K delta and CK1 epsilon, as previously described in our Blood paper. The clinical results in this paper support our thesis that the differentiated preclinical profile explains the differences seen in the clinic between umbralisib and the other PI3K delta inhibitors."

"We want to thank Dr. Burris, Dr. O’Connor and all the investigators who participated in this first-in-human Phase 1 trial for umbralisib, which has set the stage for our ongoing pivotal UNITY-CLL and UNITY-NHL trials. With over 1,000 patients treated with umbralisib to date, we and the investigators believe umbralisib is a differentiated, active and more selective PI3K delta inhibitor that exhibits a favorable safety profile as compared to prior generation molecules," stated Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer.