X4 Pharmaceuticals to Announce Third Quarter 2019 Financial Results and Provide Recent Business Highlights on November 7, 2019

On October 25, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported that it will report its financial results for the third quarter ended September 30, 2019 before market open on Thursday, November 7, 2019 (Press release, X4 Pharmaceuticals, OCT 25, 2019, View Source [SID1234542533]).

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The Company will host a conference call and webcast on the same day at 8:00 a.m. ET to discuss these financial results and business highlights. The conference call can be accessed by dialing (866) 721-7655 from the United States or (409) 216-0009 internationally, followed by the conference ID: 4081686. The live webcast can be accessed on the investor relations section of X4’s website at View Source Following the completion of the call, a webcast replay of the conference call will be available on the website.

Imago BioSciences Preliminary Data from Ongoing Phase 2 Study of IMG-7289 for the Treatment of Myelofibrosis to be Presented at the 61st American Society of Hematology Annual Meeting & Exposition

On October 25, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company focused on the treatment of myeloproliferative neoplasms (MPN) and related bone marrow diseases, reported that preliminary data from its ongoing Phase 2 study of IMG-7289 (bomedemstat) in patients with myelofibrosis (MF) has been selected for an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, on December 9 in Orlando, Florida (Press release, Imago BioSciences, OCT 25, 2019, View Source [SID1234542532]). The abstract will be published November 6, and the presentation will include results updated from those in the abstract.

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Kristen Pettit, M.D., assistant professor at the University of Michigan and investigator in the study at the Rogel Cancer Center in Ann Arbor, will present both preliminary results from Phase 2a, as well as initial data from patients from the Phase 2b expansion. The objectives of the study are to evaluate the safety and efficacy of IMG-7289 (bomedemstat) in up to 75 patients at sites in Australia, the US, UK and Europe. In this study, bomedemstat is administered orally once-daily as monotherapy in adult patients with intermediate-2 or high-risk MF resistant to or intolerant of ruxolitinib.

"The FDA recently approved a second JAK2 inhibitor but the majority of patients with myelofibrosis will eventually lose the benefit of those treatments," said Dr. Pettit. "Patients have an urgent need for new treatments that manage their symptoms. We continue to be encouraged by the bomedemstat data we see in this clinical investigation."

Imago Presentation

Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Myelofibrosis. Session: 634. Myeloproliferative Syndromes: Clinical: Emerging and Novel Targeted Therapies
Session Date: Monday, December 9, 2019
Session Time: 7:00 AM – 8:30 AM EST
Presentation Time: 7:45 AM EST
Room: Orange County Convention Center, W304EFGH

About IMG-7289

IMG-7289 (bomedemstat) is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A). LSD1 is an enzyme regulating both cytokine expression and myeloid differentiation and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, bomedemstat demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancy models, including the myeloproliferative neoplasms encompassing myelofibrosis, essential thrombocythemia and polycythemia vera. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to bomedemstat for the treatment of myelofibrosis. An international Phase 2b study of bomedemstat for the treatment of myelofibrosis remains ongoing (Clinicaltrials.gov NCT03136185). Additional clinical studies in hematologic disorders will begin in 2020.

Ventas Reports 2019 Third Quarter Results

On October 25, 2019 Ventas, Inc. (NYSE: VTR) reported its results for the third quarter ended September 30, 2019 (Press release, Ventas, OCT 25, 2019, View Source [SID1234542531]).

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"Ventas delivered strong enterprise level results in the third quarter, driven by our diverse portfolio including robust performance in our Medical Office, Healthcare and Research & Innovation portfolios, our high quality and accretive investments and effective capital markets execution. We have maintained the midpoint of our normalized FFO per share expectations for 2019, and we continue to invest in our future," said Debra A. Cafaro, Ventas Chairman and CEO.

Cafaro added, "Given challenging senior housing market conditions, our senior housing operating portfolio did not perform consistent with historical patterns or our expectations in the quarter, a trend we expect to continue for the balance of the year. As a result, while national leading indicators of supply and demand in the senior housing sector continue to improve, giving us confidence in the powerful upside that lies ahead, we have reduced our 2019 property level guidance for our senior housing operating business. This changed expectation leads us to conclude that our return to enterprise growth will occur after 2020.

"We have built a strong, diverse and resilient business well positioned to capitalize on strong demographic demand growth. We are committed to enhancing value for shareholders and are taking actions that will improve performance and deliver growth and value."

Third Quarter 2019 Company Performance

Net income attributable to common stockholders per diluted share for the third quarter 2019 was $0.23 compared to $0.28 in the same period in 2018. The year-over-year change was principally driven by the positive contribution from new investments, more than offset by higher depreciation and amortization in the third quarter 2019 and the receipt of a $12 million cash fee (the "2018 Fee") in the third quarter of 2018.
Reported Funds from Operations per share, as defined by the National Association of Real Estate Investment Trusts ("Nareit FFO") was $0.84 compared to $0.88 in the same period in 2018. The change from 2018 results was due to the factors described above, excluding the impact of depreciation and amortization.
Normalized Funds from Operations ("FFO") per share for the third quarter 2019 was $0.96 compared to $0.99 in 2018. The change from 2018 was primarily the result of growth in income from new investments, more than offset by the receipt of the 2018 Fee in the third quarter of 2018.
Third Quarter 2019 Portfolio Performance

For the third quarter 2019, the Company’s quarterly same-store total property portfolio (1,107 assets, representing 93 percent of the company’s consolidated assets) cash net operating income ("NOI") rose 0.1 percent compared to the same period in 2018. Year-to-date 2019, the Company’s full year same-store total property portfolio (1,094 assets) cash NOI grew 0.5 percent compared to the same period in 2018. Reported same-store cash NOI performance by segment for the third quarter 2019 and year-to-date 2019 are as follows:

Third quarter year-over-year changes in the Company’s same-store property results were driven by:
NNN portfolio: Growth was primarily the result of net in-place lease escalations.
SHOP portfolio: Same-store SHOP performance was below expectations, driven by the cumulative effect of new openings in a dynamic competitive market, which pressured revenue. While average third quarter 2019 occupancy was 70 basis points lower than the third quarter 2018, the year-over-year occupancy gap widened materially in September, ending the quarter approximately 115 basis points lower than third quarter-end 2018. Meanwhile, price competition drove wider re-leasing spreads year-over-year. Industry-wide, senior housing demand is accelerating and the positive trend of lower new construction starts continued, particularly in assisted living, where fewer than 1,000 units broke ground in the quarter in primary markets.
Office portfolio: Growth was led by outstanding performance in the Company’s university-based Research & Innovation ("R&I") properties and complemented by steady growth in the Company’s medical office building ("MOB") portfolio, which is benefitting from the implementation and success of operational and sustainability initiatives. Third quarter 2019 office results included a $4.7 million cash lease termination fee, which was not included in same-store results.
2019 Investment Highlights

The Company has announced $3.8 billion in year-to-date investments (at 100 percent share), including $1.8 billion in Le Groupe Maurice and $900 million in attractive R&I developments. Investment highlights from the quarter include:

Completed Portfolio Investment with Le Groupe Maurice ("LGM"): As previously announced, Ventas completed its investment in a Class A portfolio of 29 operating apartment-like senior housing assets in the attractive Quebec market, and five in-progress developments, through an equity partnership with LGM (the "LGM Acquisition"). The LGM portfolio is fully integrated and performing well.
Investment in Future Growth in R&I Development: Ventas accelerated its investments in future growth through new developments in the third quarter 2019, driven principally by the R&I development pipeline. Recent updates include:
Pitt Immune Transplant & Therapy Center:Commenced construction on a $280 million, 350,000 square foot development that is 70 percent pre-leased to the University of Pittsburgh with strong incremental leasing demand.
College of Nursing and Health Professions, Drexel University: Executed a 30-year lease with Drexel University for a new development that will house Drexel’s College of Nursing and Health Professions in the uCity Square Knowledge Community ("uCity"). Drexel’s lease is for 100 percent of the building, which will be approximately 260,000 square feet and produce an expected GAAP yield of nearly 10 percent. Construction of the College of Nursing and Health Professions is expected to commence by mid-2020 and the building is set to open by 2022.
Expanding uCity: The Ventas uCity in-place portfolio is currently 98 percent leased with robust demand, including for the recently announced One uCity development. In the third quarter of 2019, Ventas acquired land and other assets in the thriving Philadelphia uCity market, supporting an additional 450,000 square feet of developable space.
Expanding Ardent Investment at Attractive Yield: Ventas began funding a $28 million investment in the development of a new on-campus outpatient cancer center, Harrington Cancer Center, leased to Ardent Health System at an approximately eight percent cash yield, which is expected to be completed in 2021.
Redevelopment: Ventas committed to invest $36 million in redevelopment capital projects in the third quarter 2019 across four medical office buildings leased to Banner Health in Phoenix, Arizona, as well as $15 million across several SHOP assets focused on LED lighting retrofits with various operators.
2019 Office Excellence

Ventas’s office business delivered exceptional performance and achievements year to date:

The R&I portfolio delivered outstanding third quarter 2019 growth, including occupancy levels approaching 97 percent and year-over-year cash same-store NOI growth exceeding 10 percent supported by continued leasing success.
The MOB portfolio, composed of 20 million square feet, demonstrated strong positive trends on tenant satisfaction and retention, resulting from the Company’s focused efforts.
Ventas’s South Street Landing near Brown University won a Richard H. Driehaus Foundation National Preservation Award for its historic preservation work.
Financial Strength and Liquidity

Ventas’s Net Debt to Adjusted Pro Forma EBITDA ratio was 5.9x in the third quarter. As anticipated, leverage increased sequentially principally as a result of the timing of equity raised in the second quarter and the completion of the LGM Acquisition in the third quarter.
Third quarter and recent capital market activity includes:
The Company extended its maturity profile and managed interest rate risk via the issuance of $650 million of 3.00% Senior Notes due 2030, the proceeds of which were used to retire $600 million of 4.25% Senior Notes due 2022.
Ventas managed currency risk by financing a portion of the LGM Acquisition in Canadian dollars through the closing of a C$500M unsecured bank term loan in September. The term loan is attractively priced at CDOR + 90 basis points and matures in January 2025.
The Company had robust available liquidity from cash on hand and existing credit facilities totaling $1.8 billion at the end of the third quarter 2019, net of outstanding commercial paper.
Demonstrated Leadership Excellence and Commitment to ESG (Environmental, Social, Governance) Principles

Ms. Cafaro was again recognized as one of Harvard Business Review’s Top 100 Best Performing CEOs in the World for the sixth consecutive year. She is one of only 14 global CEOs who have been named to HBR’s list consistently since 2014, placing Ventas’s financial accomplishments in the top four percent of all firms measured. In addition, the Company’s non-financial performance metrics significantly improved in 2019 to its highest ever rating for the two ESG measures which make up 30% of the result.
Ventas was named to the Dow Jones Sustainability World Index for the first time and retained its place on the Dow Jones Sustainability North America Index ("DJSI"). The first global sustainability benchmark to track the largest and leading sustainability-driven publicly listed companies, only companies that rank within the top 10 percent of their industries are included in the DJSI World Index.
Ventas maintained its #1 position among the four listed healthcare real estate participants in the GRESB real estate ESG assessment for the third consecutive year. GRESB is a premier ESG benchmark for real assets, and covers more than 1,000 property companies, REITs, funds and developers.
Ventas released its second annual Corporate Sustainability Report ("CSR") earlier today. Ventas’s 2019 CSR describes the Company’s achievements, and reaffirms its commitment to ESG leadership. The CSR, which was produced consistent with globally recognized best practices, also details Ventas’s enhanced strategic ESG framework and newly-established ESG goals.
Third Quarter Dividend

The Company paid its third quarter 2019 dividend of $0.7925 per share on October 11, 2019 to stockholders of record on October 1, 2019.

Updated 2019 Guidance

Ventas is updating its outlook for 2019 per share net income attributable to common stockholders, Nareit FFO and normalized FFO, as described below. The Company is also updating its previous overall and segment same-store cash NOI growth guidance.

Assumptions for Ventas’s 2019 updated normalized FFO per share guidance are materially consistent with the Company’s previously disclosed guidance, and include the impacts of announced investments and associated capital markets activities. Total same-store guidance has been updated to reflect revisions to segment-level outlooks, with office and NNN increases more than offset by a reduction in SHOP expectations. The SHOP guidance change reflects third quarter revenue trends, a dynamic and competitive market, and lower occupancy levels entering the fourth quarter. With respect to the Company’s NNN senior housing portfolio, the Company continues to estimate that it will incur approximately a ($10 million) net impact to its NOI from proactively addressing leases with select lower credit operators, which impact is contained in non-same store results.

A reconciliation of the Company’s 2019 guidance to the Company’s projected GAAP measures is included in this press release. The Company’s 2019 guidance is based on a number of other assumptions that are subject to change and many of which are outside the control of the Company. If actual results vary from these assumptions, the Company’s expectations may change. There can be no assurance that the Company will achieve these results.

Third Quarter 2019 Conference Call

Ventas will hold a conference call to discuss this earnings release today at 10:00 a.m. Eastern Time (9:00 a.m. Central Time). The dial-in number for the conference call is (844) 776-7841 (or +1 (661) 378-9542 for international callers), and the participant passcode is "Ventas." The call will also be webcast live by NASDAQ OMX and can be accessed at the Company’s website at www.ventasreit.com. A replay of the call will be available at the Company’s website, or by calling (855) 859-2056 (or +1 (404) 537-3406 for international callers), passcode 4816549, beginning on October 25, 2019, at approximately 1:00 p.m. Eastern Time and will remain available for 30 days.

Ventas, Inc., an S&P 500 company, is a leading real estate investment trust. Its diverse portfolio of approximately 1,200 assets in the United States, Canada and the United Kingdom consists of senior housing communities, medical office buildings, university-based research and innovation centers, inpatient rehabilitation and long-term acute care facilities, and health systems. Through its Lillibridge subsidiary, Ventas provides management, leasing, marketing, facility development and advisory services to highly rated hospitals and health systems throughout the United States. References to "Ventas" or the "Company" mean Ventas, Inc. and its consolidated subsidiaries unless otherwise expressly noted. More information about Ventas and Lillibridge can be found at www.ventasreit.com and www.lillibridge.com.

The Company routinely announces material information to investors and the marketplace using press releases, Securities and Exchange Commission ("SEC") filings, public conference calls, webcasts and the Company’s website at www.ventasreit.com/investor-relations. The information that the Company posts to its website may be deemed to be material. Accordingly, the Company encourages investors and others interested in the Company to routinely monitor and review the information that the Company posts on its website, in addition to following the Company’s press releases, SEC filings and public conference calls and webcasts. Supplemental information regarding the Company can be found on the Company’s website under the "Investor Relations" section or at www.ventasreit.com/investor-relations/annual-reports—supplemental-information. A comprehensive listing of the Company’s properties is available at www.ventasreit.com/our-portfolio/properties-by-stateprovince.

Pacira to Report Third Quarter 2019 Financial Results on Thursday November 7, 2019

On October 25, 2019 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its third quarter financial results before the open of the U.S. markets on Thursday, November 7, 2019 (Press release, Pacira Pharmaceuticals, OCT 25, 2019, View Source [SID1234542530]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

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To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8077145. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 8077145. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Y-mAbs Announces Naxitamab Update

On October 25, 2019 Y-mAbs Therapeutics, Inc. (the Company or Y-mAbs) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that a clinical update on one of the Company’s lead products, naxitamab for the treatment of neuroblastoma and osteosarcoma, was made at the International Society of Pediatric Oncology (SIOP) Annual Congress held in Lyon, France (Press release, Y-mAbs Therapeutics, OCT 25, 2019, View Source [SID1234542525]). Naxitamab is currently being evaluated for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, osteosarcoma and other GD2-positive tumors. An oral presentation was made by Dr. Shakeel Modak, and a total of five (5) poster presentations were made by Dr. Brian H. Kushner and Dr. Filemon Dela Cruz, all from Memorial Sloan Kettering (MSK) in New York.

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Data from 28 patients with primary refractory high-risk neuroblastoma in Study 12-230 (NCT01757626) was presented. This comprises patients refractory to intensive induction therapy, and more than half of such patients also refractory to second line chemotherapy. Essentially, this data relates to a subset of patients from Study 12-230 that demonstrate better than expected outcomes, including a 78% overall response rate. The patients received at least five (5) cycles of therapy post major response and a subset subsequently went on to receive the Company’s investigational GD2-GD3 Vaccine at MSK. Overall, in this population a 50% two-year progression free survival was observed.

Another subset consisted of 35 patients with relapsed neuroblastoma resistant to salvage therapy, of which 30 patients were evaluable for response in the 12-230 Study. One third of the patients had two (2) or more relapses prior to enrollment and 89% of patients had previously received anti-GD2 therapy. Patients in this subset had a 36% rate of two-year progression-free survival and an overall response rate (ORR) of 37%, which indicated clinical benefit in this difficult to treat population.

Data was also presented for patients with high-risk neuroblastoma in second or later complete remission. 44 patients with no evidence of disease (NED) were treated with naxitamab and GM-CSF at MSK as maintenance therapy. In this population, where 88% had previously received an anti-GD2 therapy and 30% had previously received two or more lines of anti-GD2 therapy, a two-year progression-free survival of 52% was observed. Some of these patients went on to receive the Company’s investigational GD2-GD3 Vaccine at MSK. Due to the absence of macroscopic evaluable disease, these patients were not evaluable for a formal tumor response grading. Therefore, these patients will not form a part of the Company’s efficacy data set for its rolling biologics license application (BLA) filing currently planned to be initiated in November 2019.

Finally, safety data from the Phase II osteosarcoma trial, Study 15-096, for the 25 patients enrolled in the study at MSK was presented. Patients who had recurrent disease and two (2) or more complete remissions were treated with naxitamab and GM-CSF, administered to the patients in an outpatient setting. The Company plans to initiate a multi-center trial in 2020.

"It is both exciting and encouraging to see the efficacy data that naxitamab produces in neuroblastoma and the safety data in osteosarcoma presented this week at SIOP. We believe that we are on track to initiate the rolling BLA filling for naxitamab in combination with GM-CSF for the treatment of relapsed/refractory high-risk neuroblastoma in November this year under the breakthrough therapy designation (BTD), which the Company previously received from the FDA," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, further noted, "We are very pleased to see the response rates previously reported from Study 12-230 holding up. We are genuinely impressed with the duration of responses, and we have also observed this being replicated for the 24 patients in our international multicenter Study 201, which, we believe, will be pivotal for our rolling BLA filing for naxitamab. Based on our pre-BLA meeting with the FDA in June 2019, where data from the first 11 patients from Study 201 had been analyzed and showed a more than 70% overall response rate, we believe the response rate seems to be holding up for the complete group of patients in Study 201. We believe that this is good news for neuroblastoma patients."