Theravance Biopharma to Report Fourth Quarter and Full Year 2019 Financial Results on February 24, 2020

On February 13, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported that it will report its fourth quarter and full year 2019 financial and operating results and provide a business update after market close on Monday, February 24, 2020 (Press release, Theravance, FEB 13, 2020, View Source [SID1234554327]). An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

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Conference Call Information

To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 5775588. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through March 25, 2020. An audio replay will also be available through 8:00 p.m. ET on March 2, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 5775588.

Decipher GRID Signature Predicts Benefit from Chemotherapy in Men Diagnosed with Metastatic Prostate Cancer

On February 13, 2019 Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers, reported that a Decipher GRID molecular subtyping signature, studied in patients from the phase III, randomized controlled trial, CHAARTED, successfully predicted which prostate cancer patients diagnosed with metastatic hormone sensitive prostate cancer (mHSPC) benefited from the addition of chemotherapy to androgen deprivation hormone therapy (Press release, Deciphera Pharmaceuticals, FEB 13, 2020, View Source [SID1234554326]).

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The standard of care treatment for patients with mHSPC is androgen deprivation hormone therapy with the option for additional systemic therapy, such as taxane chemotherapy. Optimal treatment selection for these patients, however, remains challenging without knowledge of how each patient will respond. The Decipher GRID signature has demonstrated that patients with specific molecular subtypes have varying responses to systemic therapies, and investigators from the practice-changing CHAARTED trial used the signature to profile tumor tissue from trial participants and to identify which patients would receive the most benefit from the addition of taxane chemotherapy.

The investigators found that patients with the luminal B molecular subtype derived the most benefit from the addition of taxane chemotherapy, with a 55% reduction in risk of death, adding 22 months of median survival. In the trial population tested, 48% of the patients were found to have the luminal B molecular subtype. Patients with the remaining molecular subtypes received no significant survival benefit from the addition of taxane chemotherapy.

"Identifying which patients will benefit from chemotherapy is one of the most important clinical questions in the management of metastatic prostate cancer," said Christopher Sweeney, MBBS, a medical oncologist and professor of medicine at Dana-Farber Cancer Institute. "The ability to identify these patients at diagnosis is a very important step towards improving patient outcomes and accelerating the inclusion of novel drugs into the standard of care."

Results will be presented February 13, 2020, at the Genitourinary Cancer Symposium Oral Abstract A session:

Hamid A, et al. Luminal B subtype as a predictive biomarker of docetaxel benefit for newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC): A correlative study of E3805 CHAARTED. Abstract #162

Findings from nine other studies of Decipher tests will be presented at the Genitourinary Cancer Symposium:

Ganguly S, et al. Tumor cell intrinsic androgen biosynthesis by 3β-hydroxy steroid dehydrogenase (HSD3B1) to modulate radiosensitivity in prostate cancer cells. Abstract #349

Grist E, et al. Multiregion expression profiling of prostate cancer from men randomized in the STAMPEDE trial: Stage I results of a multistage biomarker analysis. Abstract #349

Gupta S et al. Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy. Abstract #439

Feng FY, et al. Transcriptome profiling of NRG Oncology/RTOG 9601: Validation of a prognostic genomic classifier in salvage radiotherapy prostate cancer patients from a prospective randomized trial. Abstract #276

King M, et al. INTREPId (INTermediate Risk Erection Preservation Trial): A randomized trial of radiation therapy and darolutamide for prostate cancer. Abstract #TPS384

Muralidhar V, et al. Clinical-genomic sub-classification of high-risk prostate cancer: Implications for tailoring therapy and clinical trial design. Abstract #337

Necchi A, et al. Association of an immune-gene signature with pathologic response and outcome after neoadjuvant pembrolizumab (pembro), compared to neoadjuvant chemotherapy (NAC), in muscle-invasive bladder cancer (MIBC). Abstract #533

Necchi A, et al. Development of a composite biomarker-based calculator to predict the probability of pathologic complete response (pT0) after neoadjuvant pembrolizumab (pembro) in muscle invasive bladder cancer (MIBC). Abstract #539

Shahait M, et al. Head-to-head comparison between decipher and prolaris tests: Two commercially available post-prostatectomy genomic tests. Abstract #348
About Decipher Prostate RP and Decipher GRID

Our Decipher Prostate RP genomic tests are currently marketed and sold to physicians treating prostate cancer through the adjuvant therapy decision for patients who have received a radical prostatectomy and are being considered for additional therapy. The test reports the Decipher score which prognosticates a patient’s risk of metastasis within five years. The Decipher score is intended to improve clinical decision making by helping physicians identify patients who have high risk of metastasis and require more intensive therapy or who have low risk of metastasis and can reduce treatment intensity. We have obtained Medicare coverage for patients, including for those who have been diagnosed with adverse pathology following a radical prostatectomy and are being considered for additional therapy. Decipher Prostate RP can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Decipher GRID is our Real-World Evidence genomic database containing over 75,000 urologic cancer transcriptomes matched to patient demographics and including clinical trial outcome data, which is one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID’s patient data is derived from decades of clinical trials and is continuously being expanded through a growing community of pharmaceutical and academic partners. The diversity of clinical sample inputs, ranging from global clinical trials to standard-of-care practices in urban, suburban and rural centers, help provide a comprehensive view of the future and current states of the practice of urologic cancer care. We leverage Decipher GRID outputs to partner with investigators and pharmaceutical companies to help identify patient populations that might benefit from earlier use of proprietary drugs or combination therapeutic strategies, or that are prime candidates for novel therapeutics. Decipher GRID is our proprietary engine that drives product development for us, and informs the product development efforts for our pharmaceutical partners.

Medicenna Reports Third Quarter Fiscal 2020 Financial Results

On February 13, 2020 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA;OTCQB: MDNAF), a clinical stage immuno-oncology company, reported financial results for the three and nine months ended December 31, 2019 (Press release, Medicenna Therapeutics, FEB 13, 2020, View Source [SID1234554325]). The Company’s fiscal Q3 2020 interim financial statements and MD&A will be available on SEDAR.

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"We have achieved a number of exciting and important milestones this quarter, both in the ongoing development of MDNA55 and MDNA19 and in further strengthening our financial position as we swiftly advance towards the important End of Phase 2 meeting with the FDA this spring," said Dr. Fahar Merchant, President and CEO, Medicenna Therapeutics. "We’ve documented exceptional survival advantage rates with MDNA55 in patients with the most difficult to treat form of brain cancer when compared to today’s commonly used treatments, and will have key non-human primate data for MDNA19 this quarter as we accelerate development of our second important asset. Recent acquisitions in the space are further evidence that Medicenna is ideally positioned in a market that is growing in both opportunity and value, as major pharmaceutical companies recognize the necessity of novel IL2 assets like MDNA19 to support their cancer portfolio."

The following are the achievements and highlights for the quarter ending December 31, 2019, through to the date hereof:

On January 13, 2020, Medicenna announced results from a retrospective study of subjects with recurrent glioblastoma ("rGBM") receiving standard therapies who matched eligibility requirements of subjects enrolled in the MDNA55-05 clinical trial (Synthetic Control Arm, or SCA), and compared their survival versus subjects treated with MDNA55 in the Phase 2b rGBM clinical trial. The SCA comprised of 81 rGBM patients receiving standard therapies, including Avastin, Lomustine and Temozolomide, with similar baseline features as patients treated in the MDNA55 trial (including age, tumor size, ineligibility for surgery, lack of IDH mutations, IL4R expression and other parameters known to affect survival). A 150% survival advantage was seen in patients who received MDNA55, when comparing IL4R High groups across the two populations.
On January 8, 2020, Medicenna announced receipt of $1.3 million in proceeds from the exercise of previously issued warrants. Of this amount, $985,443 was received as of December 31, 2019.
On December 12, 2019, Medicenna President and CEO Dr. Fahar Merchant presented subgroup analysis data from the first 40 patients treated with MDNA55 in a Phase 2b clinical trial for patients with rGBM at the Inaugural Glioblastoma Drug Development Annual Summit.
On November 25, 2019, Medicenna announced the presentation of updated clinical results from its Phase 2b trial of MDNA55 at the 24th Society for Neuro-Oncology ("SNO") annual meeting. The presentation was delivered by Dr. John Sampson and discussed updated efficacy results from the Phase 2b clinical trial of MDNA55 in rGBM patients using the IL4R as an immunotherapy target.
On November 21, 2019, Medicenna announced positive new results on drug distribution from the completed Phase 2b clinical trial of MDNA55. The results showed that implementing new advances in Convection Enhanced Delivery ("CED") allows the drug to bypass the blood-brain barrier and deliver high concentrations of MDNA55 directly to the tumor and the at-risk area immediately surrounding it, without exposure to the rest of the body. This approach, along with the ability to continuously monitor distribution using real-time imaging allows Medicenna to dramatically improve drug delivery and maximize tumor coverage.
On October 17, 2019, Medicenna completed an oversubscribed public offering raising total gross proceeds of $6,900,000. The Company issued 5,307,693 units at $1.30, consisting of one common share and one-half common share purchase warrant. Each whole warrant is exercisable at $1.75 until October 17, 2022.
Financial Results

Medicenna had a cash balance of $6,974,004 at December 31, 2019 and subsequent to the quarter end has received $856,100 in proceeds from warrant exercises. The funds available are sufficient to complete the MDNA55 Phase 2b clinical study and planned End of Phase 2 meeting with the US FDA, continue the development of MDNA19 and finance operations through 2020. In addition, Medicenna has access to another US$1.4 million from the CPRIT grant.

For the three months ended December 31, 2019, Medicenna reported a net loss of $2,389,463 or $0.07 per share compared to a loss of $1,723,081 or $0.07 per share for the three months ended December 31, 2018. The increase in net loss in the current year period was primarily a result of a lower amount of costs reimbursed under the CPRIT grant in the current year period ($nil) compared with the prior year period ($1,033,072).

The press release, the financial statements and the management’s discussion and analysis for the quarter ended December 31, 2019 will be available on SEDAR at www.sedar.com

Triple-S Management Corporation Schedules Fourth Quarter 2019 Earnings Release and Conference Call

On February 13, 2020 Triple-S Management Corporation (NYSE: GTS) reported that it plans to release financial results for the fourth quarter ended December 31, 2019 before the market opens on Thursday, February 27, 2020 (Press release, Triple-S Management, FEB 13, 2020, https://www.prnewswire.com/news-releases/triple-s-management-corporation-schedules-fourth-quarter-2019-earnings-release-and-conference-call-301004172.html [SID1234554324]). Roberto García-Rodríguez, President and Chief Executive Officer, and Juan José Román-Jiménez, EVP and Chief Financial Officer, will host a conference call to discuss these results at 8:30 a.m. Eastern Time.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To participate on the call, please dial 1-877-451-6152 or 1-201-389-0879 at least 5 minutes before start time. The conference call will also be simulcast live on the Internet, and can be accessed by logging onto www.triplesmanagement.com.

In addition, a replay will be available through March 12, 2020 by calling 1-844-512-2921 or 1-412-317-6671 and entering replay pin number 13698869. A replay will also be available at www.triplesmanagement.com for 30 days.

ViewRay Announces Conference Call and Webcast of Fourth Quarter and Full Year 2019 Financial Results to be Held After Market on March 12, 2020

On February 13, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that details relating to the release of its fourth quarter and full year 2019 financial results (Press release, ViewRay, FEB 13, 2020, View Source [SID1234554323]).

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ViewRay will hold a conference call to discuss results on Thursday, March 12, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525 -7129 for international callers. The conference ID number is 6095383. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until March 19, 2020. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 6095383.