On August 7, 2019 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will present at the 2019 Wedbush Pacgrow Healthcare Conference at 12:45 PM ET on Tuesday, August 13, 2019 (Press release, Pacira Pharmaceuticals, AUG 7, 2019, View Source [SID1234538328]). Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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On August 7, 2019 Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, Proteostasis Therapeutics, AUG 7, 2019, View Source [SID1234538345]).

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"PTI continues to advance the clinical development of our proprietary combination cystic fibrosis transmembrane conductance regulator (CFTR) modulators. We recently initiated dosing in the 28-day global Phase 2 study of our doublet (PTI-808 and PTI-801) and triplet (PTI-808, PTI-801 and PTI-428) combinations in F508del homozygous and heterozygous CF subjects and we remain on track to report top line results from this study in the first quarter of 2020. The CF community continues to seek alternatives to today’s standard of care CFTR modulator therapy, validating PTI’s mission to provide additional disease-modifying treatment options for patients with CF," said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics.

Recent Highlights and Upcoming Milestones

During the first quarter, PTI appointed Dr. Badrul Chowdhury, the former FDA Director of Pulmonology, Allergy, and Rheumatology, to the Company’s board of directors. Dr. Chowdhury is Senior Vice President and Chief Physician-Scientist, Respiratory Inflammation and Autoimmunity (RIA) Late Stage, R&D Biopharmaceuticals, at AstraZeneca. He was previously Director of the Division of Pulmonary, Allergy, and Rheumatology Products at the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).

In May, the European Commission (EC) granted orphan drug designation (ODD) to PTI-428 for the treatment of cystic fibrosis. PTI-428 is the Company’s proprietary CFTR amplifier that is currently in clinical development. In addition to ODD from the EC, PTI-428 has Orphan Drug Designation, Breakthrough Therapy Designation and Fast Track Designation from the U.S. Food and Drug Administration.

Data from the Company’s CF clinical development programs were presented during three panel presentations at the 42nd European Cystic Fibrosis Society (ECFS) Conference in June. The panel presenters were Damian Downey, M.D., Clinical Senior Lecturer in Respiratory Medicine, Queen’s University Belfast, Belfast, UK; Manu Jain, M.D., Professor of Medicine (Pulmonary and Critical Care) and Pediatrics, Northwestern Medicine (Feinberg School of Medicine), Chicago, IL, US; and Geoffrey Gilmartin of PTI.

In July, PTI announced the appointment of Geoffrey S. Gilmartin, M.D., M.M.Sc., as the Company’s Chief Medical Officer (CMO), and Andrey E. Belous, M.D., Ph.D., as a Senior Medical Director. Dr. Gilmartin most recently served as Chief Medical Affairs Officer of the Company. Dr. Belous joined the Company from Galapagos NV (NASDAQ:GLPG), where he most recently served as a Medical Director for the company’s Phase 3 program in Idiopathic Pulmonary Fibrosis (IPF).

PTI announced in July that the first patient was dosed in the Company’s 28-day, Phase 2 study evaluating its proprietary CFTR modulator combinations in CF subjects. The global, multicenter, randomized, placebo-controlled study is expected to enroll up to 30 F508del homozygous patients and up to 30 F508del heterozygous patients. Dose selection (600 mg of PTI-801 and 300 mg of PTI-808, with or without 10 mg PTI-428) was based on the totality of dose range finding data from approximately 250 CF subjects studied thus far. Study endpoints include safety, changes in sweat chloride concentration and changes in ppFEV1. Data from the study are expected in the first quarter of 2020.

Second Quarter 2019 Financial Results

Proteostasis reported a net loss of approximately $20.0 million for the three months ended June 30, 2019, as compared to a net loss of $15.5 million for the same period in the prior year.

There was no revenue for the three months ended June 30, 2019, as compared to $0.8 million for the same period in the prior year. Revenue for the three months ended June 30, 2018 was related to the collaboration agreement with Astellas, or the Astellas Agreement, which ended in the fourth quarter of 2018.

Research and development expenses for the three months ended June 30, 2019 were $16.9 million, as compared to $12.6 million for the same period in the prior year. The increase in research and development expenses was primarily due to an increase in clinical-related research activities, as well as increases in employee-related expenses and professional fees.

General and administrative expenses for the second quarter of 2019 were $3.7 million, as compared to $4.0 million for the same period in the prior year. The decrease in general and administrative expenses was primarily due to a decrease in professional fees and employee-related expenses.

Cash, cash equivalents and short-term investments totaled $88.0 million as of June 30, 2019, compared to $105.3 million as of March 31, 2019. We believe that our existing cash, cash equivalents and short-term investments are sufficient to fund our operations into 2021, allowing us to complete our Phase 2 studies and initiate key activities to support our Phase 3 program. As part of its effort to deliver new treatment options to CF patients in geographies around the world, the Company also announced today that it is exploring partnership opportunities to maximize the value of its assets.

On August 7, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its second quarter 2019 financial and operating results on Wednesday, August 14, 2019, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, AUG 7, 2019, View Source [SID1234538450]). The announcement will be followed by a conference call and webcast with the investment community at 4:30 p.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, Founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

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Conference call and webcast details:

Investors (domestic): 877-407-0792
Investors (international): 201-689-8263
Conference ID: 13693605

To access a live webcast of the update, please use the following link:
View Source

On August 7, 2019, Phio Pharmaceuticals Corp. ("we" or the "Company") reported that it has entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $10,000,000 in shares of the Company’s common stock, $0.0001 par value per share (the "Common Stock"), subject to certain limitations and conditions set forth in the Purchase Agreement (Filing, 8-K, Phio Pharmaceuticals, AUG 7, 2019, View Source [SID1234538542]).

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Under the Purchase Agreement, the Company has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 200,000 shares of Common Stock on any business day (or $50,000 worth of common stock, whichever is greater) (the "Regular Purchase Amount"). The Company may increase the amount which it directs LPC to purchase, up to a maximum of 500,000 shares of Common Stock, if on the date of the purchase the closing sale price of the Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement, subject in each case to $1,000,000 in total purchase proceeds per purchase date. The purchase price of shares of Common Stock will be based on the market prices of the Common Stock at the time of such purchases. Such sales of Common Stock by the Company, if any, may occur from time to time, at the Company’s option, over the 30-month period commencing on the date that a registration statement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other terms and conditions of the Purchase Agreement are satisfied.

In addition to regular purchases, the Company may also direct LPC to purchase additional amounts as accelerated purchases or as additional purchases if the Company has utilized the Regular Purchase Amount in full and if the closing sale price of the Common Stock exceeds certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 9.99% of the Common Stock.

The Purchase Agreement also limits the Company’s issuance of shares of Common Stock to Lincoln Park thereunder to 5,015,730 shares of Common Stock, representing 19.99% of the shares of Common Stock outstanding on the date of the Purchase Agreement unless (a) stockholder approval is obtained to issue more than such amount or (b) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds the lower of (i) the closing price of our common stock on the Nasdaq Capital Market immediately preceding August 7, 2019 or (ii) the average of the closing price of our common stock on the Nasdaq Capital Market for the five Business Days immediately preceding August 7, 2019.

LPC represented to the Company, among other things, that it was an "accredited investor" (as such term is defined in Rule 501(a)(3) of Regulation D under the Securities Act of 1933, as amended (the "Act")), and the Company sold the securities in reliance upon private placement exemptions from the registration requirements under Section 4(a)(2) of the Act, as well as Rule 506 under Regulation D under the Act. The Company has agreed with Lincoln Park that it will not enter into any "variable rate" transactions with any third party for a period defined in the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of LPC’s control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by LPC, until such event of default is cured.

Actual sales of shares of Common Stock to LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. As a commitment fee for entering into the Purchase Agreement, the Company has agreed to issue to LPC 500,000 shares of Common Stock (the "Commitment Shares"). The Company will not receive any cash proceeds from the issuance of the Commitment Shares.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

On August 7, 2019 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the second quarter ended June 30, 2019 and provided a business update (Press release, Radius, AUG 7, 2019, View Source [SID1234538295]).

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"I am delighted to see continued market share growth of TYMLOS, which puts us on track to attain our goal of anabolic leadership of new patient starts in the second half of 2019," said Jesper Hoeiland, President and Chief Executive Officer of Radius. "Initiation of the Company’s Phase 3 abaloparatide-patch study has been a major milestone toward our mission of addressing the needs of osteoporosis patients."

TYMLOS (abaloparatide) injection

Second quarter 2019 U.S. net sales of TYMLOS were $41.0 million, an 81% increase from the second quarter of 2018. The anabolic market grew 4% in the first half of 2019 as compared to the first half of 2018.

In the second quarter of 2019, TYMLOS continued to increase its market share and captured, on average, 35% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) and 46% of new anabolic patient starts (NBRx).

During the second half of 2019, Radius expects TYMLOS to become the NBRx anabolic market leader by reaching over 50% of new patient starts. If achieved, the Company further expects this performance would translate to total TRx market leadership for TYMLOS during 2020.

Financial Guidance

Radius tightens its full-year 2019 financial guidance for TYMLOS U.S. net sales to $165 to $170 million and increases guidance for its year-end cash, cash equivalents and investments balance to over $120 million.

Pipeline Highlights

Abaloparatide-Patch

In July 2019, Radius obtained preliminary results from the abaloparatide-transdermal patch (abaloparatide-patch) patient assessment study which evaluated self-administration of abaloparatide-patch over 29 days in 22 postmenopausal women with low bone density. The patients were observed at a study site on the first, 15th and 29th day of the study. Top-line study results showed that patients were able to follow the instructions for use (IFU) and applied the patches with a 99.7% success rate. The data also measured patient acceptability and indicated changes in patient PINP (procollagen type I propeptide) levels. The mean subject acceptability score on a 5-point scale was ≥ 4.5 at each site visit. An exploratory assessment of PINP levels, a biomarker that indicates bone formation, compared the PINP results at one month in this study with the one-month results in the Phase 3 ACTIVE study of TYMLOS (abaloparatide injection). The PINP levels and baseline increase at one month in this study were consistent with those values seen with abaloparatide injection at one month in the ACTIVE trial. At baseline, the median PINP level was 50.5 ng/ml, increasing to a median value of 100.1 ng/ml at day 29. The median PINP values observed with abaloparatide injection in the ACTIVE study were 50.6 ng/ml at baseline and 100.5 ng/ml at one month.

On August 5, 2019, the first patient was randomized in the Phase 3 wearABLe clinical trial studying the safety and efficacy of abaloparatide-patch in the treatment of postmenopausal patients with osteoporosis at high risk for fracture.

Prior to initiating the study, the Company achieved a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the acceptability of the overall protocol design. An SPA agreement provides a concurrence with the FDA that the study can be considered adequate and well-controlled in support of a marketing application.

The wearABLe Phase 3 study is a pivotal, randomized, open label, active-controlled, bone mineral density ("BMD") non-inferiority bridging study that will evaluate the efficacy and safety of abaloparatide-patch versus TYMLOS (abaloparatide injection) in approximately 470 patients with postmenopausal osteoporosis at high risk of fracture. The primary endpoint of the study is the percentage of change in lumbar spine BMD at 12 months. Non-inferiority of abaloparatide-patch to abaloparatide injection will be concluded if the lower bound of the 2-sided 95% confidence interval for the estimated treatment difference (abaloparatide-patch minus abaloparatide injection) in the percentage change from baseline in lumbar spine BMD at 12 months is above -2.0%. A non-inferiority margin of 2% preserves ~77% of the historical effect of TYMLOS based on the data from the Phase 3 ACTIVE Study which showed placebo-adjusted increase in lumbar spine BMD of 9.1% (95% CI: 8.6%, 9.6%) at 12 months.

The wearABLe Phase 3 study is currently open for enrollment at multiple clinical sites. Radius plans to complete patient recruitment in this study by the end of 2019.

Anticipated Milestones in 2019

Elacestrant

Advance recruitment in Phase 3 EMERALD monotherapy study

Global co-development/co-commercialization partnership for elacestrant

Initiate a combination trial for elacestrant in conjunction with a partner

TYMLOS/Financial

Grow full-year TYMLOS U.S. net sales to between $165M to $170M

Deliver greater than $120M cash, cash equivalents and investments balance at year-end

Expected Radius Presentations at Upcoming Conferences in Q2 2019

On September 5, 2019, the Company will host one-on-one meetings at the Citi’s 14th Annual Biotech Conference in Boston, MA.

On September 11, 2019, the Company will present and host one-on-one meetings at the Morgan Stanley 17th Annual Global Healthcare Conference in New York City, NY.

Second Quarter 2019 Financial Results

Three Months Ended June 30, 2019

For the three months ended June 30, 2019, Radius reported a net loss of $35.5 million, or $0.77 per share, compared to a net loss of $68.9 million, or $1.52 per share, for the three months ended June 30, 2018.

For the three months ended June 30, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $25.4 million, or $0.55 per share, compared to non-GAAP adjusted net loss of $44.6 million, or $0.98 per share, for the three months ended June 30, 2018.

For the three months ended June 30, 2019, TYMLOS net product revenues were $41.0 million compared to approximately $22.6 million for the three months ended June 30, 2018.

For the three months ended June 30, 2019, research and development expense was $27.2 million compared to $26.3 million for the three months ended June 30, 2018, an increase of $0.9 million, or 3%. This increase was primarily driven by a $5.0 million increase in abaloparatide-patch project costs, and a $0.5 million increase in abaloparatide-SC project costs. These increases were partially offset by a $0.7 million decrease in project costs for elacestrant, a $0.3 million decrease in professional costs, and a $3.6 million decrease in compensation expenses.

For the three months ended June 30, 2019, selling, general and administrative expense was $40.1 million compared to $48.6 million for the three months ended June 30, 2018, a decrease of $8.5 million, or 17%. This decrease was primarily the result of a $6.2 million decrease in compensation related expenses attributed to a decrease in headcount from 338 selling, general, and administrative employees as of June 30, 2018 to 289 selling, general, and administrative employees as of June 30, 2019, a $1.2 million decrease in professional costs, a $0.3 million decrease in travel and expense related costs, and a $0.8 million decrease in occupancy, depreciation, and other operating costs.

Six Months Ended June 30, 2019

For the six months ended June 30, 2019, Radius reported a net loss of $78.2 million, or $1.70 per share, compared to a net loss of $130.4 million, or $2.89 per share, for the six months ended June 30, 2018.

For the six months ended June 30, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $57.2 million, or $1.25 per share, compared to non-GAAP adjusted net loss of $94.7 million, or $2.10 per share, for the six months ended June 30, 2018.

For the six months ended June 30, 2019, TYMLOS net product revenues were $70.9 million compared to approximately $37.2 million for the six months ended June 30, 2018.

For the six months ended June 30, 2019, research and development expense was $50.4 million compared to $49.2 million for the six months ended June 30, 2018, an increase of $1.3 million, or 3%. This increase was primarily driven by a $6.8 million increase in abaloparatide-patch project costs, a $2.4 million increase in project costs for elacestrant, and a $0.9 million increase in abaloparatide-SC project costs. These increases were partially offset by a $1.2 million decrease in RAD140 project costs, a $0.5 million decrease in occupancy and depreciation costs, a $0.4 million decrease in other operating and support costs, and a $6.7 million decrease in compensation expenses.

For the six months ended June 30, 2019, selling, general and administrative expense was $81.3 million compared to $96.6 million for the six months ended June 30, 2018, a decrease of $15.3 million, or 16%. This decrease was primarily the result of a $10.8 million decrease in compensation related expenses attributed to a decrease in headcount from 338 selling, general, and administrative employees as of June 30, 2018 to 289 selling, general, and administrative employees as of June 30, 2019, a $2.8 million decrease in travel and expense related costs, a $1.0 decrease in professional fees, and a $1.0 million decrease in other operating costs. These decreases were partially offset by a $0.3 million increase in occupancy and depreciation expenses.

As of June 30, 2019, Radius had $189.0 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of June 30, 2019, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.