On November 6, 2018 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Monday, November 12, 2018 following release of its third quarter 2018 financial results (Press release, Oncolytics Biotech, NOV 6, 2018, View Source [SID1234530862]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The live call may be accessed by dialing (888) 231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at 855-859-2056, using the replay code 6463668 and will be available for six months.

A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for six months

On November 6, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported financial results for the third quarter ended September 30, 2018, and provided an update on recent developments (Press release, Bellicum Pharmaceuticals, NOV 6, 2018, View Source [SID1234530879]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We made significant progress during the quarter across our programs. Rivo-cel remains on track for MAA filing in the E.U. in 2019 for pediatric patients with acute leukemias and nonmalignant blood diseases," said Bellicum’s President & CEO Rick Fair. "We also received and incorporated health authority input on our planned late-stage trial in adult AML and MDS and remain on track to initiate the trial by year-end."
Continued Mr. Fair: "In our GoCAR-T programs, we are nearing completion of the dose escalation portion of our Phase 1/2 study of BPX-601 in solid tumors, and expect to report preliminary results from the lower dose cohorts in patients with advanced pancreatic cancer in December. We also made substantial progress toward IND applications for two new dual-switch GoCAR-T candidates in 2019."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
On Track to Initiate Phase 2/3 Study of Rivo-cel in Adult AML and MDS by Year-end
Based on impressive clinical trial results to date with rivo-celTM (rivogenlecleucel, formerly called BPX-501) in pediatric leukemia patients, Bellicum is finalizing its plans to initiate a global Phase 2/3 trial in adult patients with intermediate/high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) by the end of the year. The Company completed review of the study protocol with the U.S. FDA in the third quarter and has incorporated its input into the design of the trial.

Rivo-cel Pediatric Registration Trials on Track for E.U. Filing in 2019; Significant Data Update at ASH (Free ASH Whitepaper) 2018
Prospective enrollment was recently completed in the BP-004 and C-004 E.U. registration trials of pediatric patients with leukemias, lymphomas and inherited blood disorders. These trials will serve as the basis for the Company’s planned 2019 European Marketing Authorization Application regulatory filing. In December, Bellicum will present interim data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual meeting, with final results expected in early 2019. Among the highlights will be late interim analyses of the overall results from the BP-004 trial in children with acute leukemias and nonmalignant blood diseases, as well as the comparator C-004 trial-a multicenter, observational study of similar pediatric patients receiving a matched unrelated donor (MUD) transplant. Disease outcomes from several patient subsets, as well as the cumulative clinical experience of patients from BP-004 who received rimiducid to treat steroid refractory Graft-versus-Host-Disease will also be presented. ASH (Free ASH Whitepaper) 2018 is being held in San Diego, California on December 1-4.

Commercial Planning Activities for Rivo-cel Continue to Advance in Europe
Under the recently appointed General Manager of Europe, Thierry Darcis, M.D., M.B.A., Bellicum continues to build out an E.U.-based team to prepare for the commercialization of rivo-cel, if approved. Dr. Darcis and his leadership team have extensive experience launching orphan products in Europe, and Dr.

1

Exhibit 99.1

Darcis has previously led successful product introductions for ViroPharma and NPS Pharmaceuticals. He also held leadership roles with Zogenix, Novartis and GlaxoSmithKline.

Initial Clinical Data on BPX-601 To Be Presented at ESMO (Free ESMO Whitepaper) Immuno-Oncology Conference
BPX-601 is Bellicum’s first GoCAR-T clinical candidate incorporating the co-activation domain, iMC. The Company expects to report preliminary safety and translational findings from the lower cell-dose cohorts of its Phase 1 dose-escalation safety study in late-stage pancreatic cancer patients at the European Society for Medical Oncology Immuno-Oncology Conference in Geneva, Switzerland in December. The Company is evaluating BPX-601 in adults with relapsed or refractory pancreatic, gastric, and prostate cancers who test positive for prostate stem cell antigen (PSCA).

Preclinical Dual-Switch Candidates On Track to Enter Clinic in 2019
Bellicum’s research team continues to advance its next-generation GoCAR-T projects, which have been designed with both activation and safety switch technologies to potentially enhance efficacy and safety. The Company expects to submit IND applications for two new dual-switch GoCAR-T product candidates in 2019.

Third Quarter 2018 Financial Results
Bellicum reported a net loss of $23.8 million for the third quarter of 2018 and $70.8 million for the nine months ended September 30, 2018, respectively, compared to a net loss of $23.4 million and $69.9 million for the comparable periods of 2017. The results included non-cash, share-based compensation charges of $3.7 million and $10.9 million for the third quarter and nine months ended September 30, 2018, and $3.7 million and $10.2 million for the comparable periods in 2017.
As of September 30, 2018, cash, restricted cash and investments totaled $118.4 million. Based on current operating plans, Bellicum continues to expect that current cash resources will be sufficient to meet operating requirements through 2019.
Research and development expenses were $16.4 million and $51.4 million, for the three and nine months ended September 30, 2018, respectively, compared to $18.1 million and $51.4 million during the comparable periods in 2017.
General and administrative expenses were $7.0 million and $18.0 million for the three and nine months ended September 30, 2018, respectively, compared to $4.6 million and $16.0 million during the comparable periods in 2017.
At September 30, 2018, Bellicum had 43,351,159 shares of common stock outstanding.

About Rivo-cel (BPX-501)
Rivo-celTM (rivogenlecleucel) is an allogeneic polyclonal T cell product designed to reduce relapse of leukemia following a stem cell transplant. The cell treatment contains a diverse repertoire of T cells which may contribute to a robust graft vs. leukemia effect. Rivo-cel’s antiviral benefits may also reduce morbidity and mortality in patients susceptible to infection following a transplant. The product’s CaspaCIDe safety switch enables this approach by allowing physicians to reduce the number of alloreactive cells in the event of uncontrolled GvHD. Rivo-cel addresses a major unmet need in adult and pediatric leukemia, lymphoma and genetic blood disease patients following a haploidentical stem cell transplant.
About BPX-601
BPX-601, the Company’s first GoCAR-T product candidate, incorporates iMC, Bellicum’s inducible co-activation domain. iMC (inducible MyD88/CD40) is designed to provide a powerful boost to T cell proliferation and persistence, and enable the CAR-T to override key immune inhibitory mechanisms,

2

Exhibit 99.1

including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for solid tumors expressing prostate stem cell antigen (PSCA), including pancreatic, prostate and gastric cancers.

On November 6, 2018 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported updated results from its Phase 1 ALX148 solid tumor program in patients with advanced malignancy at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting. The data will be further discussed in an oral presentation (Press release, ALX Oncology, NOV 6, 2018, View Source [SID1234530942]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In the trial, fifty-seven patients with advanced solid tumor malignancies have been administered ALX148 in combination with standard regimens of either pembrolizumab or trastuzumab as of the Oct 12, 2018 data cutoff. ALX148 was generally well tolerated in combination and no maximum tolerated dose was reached. The most common treatment related adverse events were Fatigue (9%) and ALT increase (7%). While the majority of 18 evaluable dose expansion patients had undergone only one initial response assessment, preliminary anti-tumor activity and decreased tumor burden were seen across all cohorts and combinations, including patients whose tumors are resistant/refractory to prior checkpoint inhibitors or trastuzumab.

"Intended for combination treatments, ALX148 is designed to avoid the dose-limiting toxicities associated with other CD47-targeted approaches in the clinic while maximizing the efficacy of antibody-based therapies," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of ALX Oncology. "The favorable safety profile and preliminary anti-cancer activity of ALX148 in combination with standard regimens of pembrolizumab and trastuzumab support our hypothesis. ALX148 exhibits an encouraging profile with respect to tolerability, pharmacokinetics and CD47 target occupancy, which allows it to be administered using a simple weekly regimen. With broad therapeutic potential across many types of cancer, we are excited to continue evaluating the clinical benefit of ALX148."

Presentation details:

Title: A phase 1 study of ALX148: CD47 blockade in combination with anticancer antibodies to bridge innate and adaptive immune responses for advanced malignancy

Oral session –

Date/Time: Saturday, November 10, 12:55 p.m.

Oral Presentation Location: 204ABC

Presenter: Nehal Lakhani, M.D., Ph.D. – START-Midwest

Poster session –

Poster Number: P335

Poster Location: Hall E

Date/Time: Friday, Nov. 9 from 8 a.m. – 8 p.m. and Saturday, Nov. 10 from 8 a.m. – 8:30 p.m.

ALX further presented data on the clinical pharmacokinetics (PK) and pharmacodynamics of ALX148. The PK properties of ALX148 are similar to anti-CD47 antibodies with a projected half-life of 16 days at the current dosing regimen of 10 mg/kg once weekly. This ALX148 dosing regimen is equivalent to 20 mg/kg once weekly of an anti-CD47 antibody and achieves complete CD47 target occupancy.

Presentation details:

Title: Pharmacokinetic and pharmacodynamic characterization of ALX148, a CD47 blocker, in patients with advanced malignancy and non-Hodgkin lymphoma

Poster number: P340

Poster Location: Hall E

Date/Time: Friday, Nov. 9 from 8 a.m. – 8 p.m. and Saturday, Nov. 10 from 8 a.m. – 8:30 p.m.

About ALX148

ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity via Fc-dependent and Fc-independent mechanisms to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells.

The ALX148 Phase 1 clinical trial is a two-part study that evaluates the safety, pharmacokinetics, and pharmacodynamics of ALX148. Enrollment to the combination therapy portion in which ALX148 is administered with approved anti-cancer antibodies is ongoing. For more information about the Phase 1 study, please visit clinicaltrials.gov, identifier number NCT03013218.

On November 6, 2018 Oncoceutics, Inc. reported that it will host an investigator meeting and that initial efficacy data of its lead compound ONC201 in patients with H3 K27M-mutant gliomas will be presented at the 2018 Annual Meeting of the Society for Neuro-Oncology in New Orleans, on November 15th to November 18th (Press release, Oncoceutics, NOV 6, 2018, View Source [SID1234558365]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The company, along with scientific and medical collaborators, will give 10 presentations that describe several aspects of ONC201, including clinical efficacy and safety, mediated via highly specific interaction with dopamine receptor 2 (DRD2), unique molecular characteristics, and novel insights on dopamine receptor dysregulation in glioma. Moreover, presentations will include the preclinical effectiveness and mechanism of action of ONC206, another molecule from this newly established class of compounds, called imipridones. One of the highlights of the event will be an oral presentation entitled, "Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients," which scored highly in the review process of the SNO conference and will be one of three selected abstracts to be presented by a discussant separate from the oral presentation. The data set that will be disclosed will focus on radiographic and clinical responses in H3 K27M-mutant glioma patients from several clinical programs with ONC201.

"The reported findings are very meaningful for the medical community, and we look forward to sharing our experience with ONC201 in this first group of patients," said Yazmin Odia, MD, Lead Physician of Medical Neuro-Oncology, Miami Cancer Institute. "Patients with H3 K27M-mutant gliomas have a dismal prognosis, and there is currently no known effective drug for these patients."

Additionally, Oncoceutics will hold an investigator meeting for physicians involved in ongoing and future clinical trials with ONC201.

"We are conducting a number of clinical trials to translate these compelling findings into robust clinical data sets," said Wolfgang Oster, MD, PhD, and CEO of Oncoceutics. "We are excited about the progress in our development programs and hope that our findings will make a difference for patients with unmet medical need. We are grateful to the Society for Neuro-Oncology and its members for their interest and collaboration."

More Information: Imipridone-related SNO 2018 Abstracts

ONC201 glioma clinical experience (3 abstracts)

ACTR-34 (Talk): Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients, Chi et al, Sunday November 18th, 8:50-9:00am
ACTR-33 (Talk): Tumor Tissue Penetration and Pharmacodynamics of ONC201 in Adult Recurrent Glioblastoma Patients, Arrillaga-Romany et al, Friday November 16th, 2:40-2:45pm
PDCT-06 (Talk): Phase I clinical trial of ONC201 in pediatric H3 K27M-mutant glioma or newly diagnosed DIPG, Gardner et al, Friday November 16th, 8:22-8:26pm
DRD2 dysregulation in glioma and ONC201 preclinical efficacy (4 abstracts)

DRES-10 (Talk): DRD5 is a modulator of glioma susceptibility to DRD2 antagonism by ONC201, Prabhu et al, Sunday November 18th, 11:25-11:30am
EXTH-26 (Poster): Molecular determinant of clinical response to ONC201, an inhibitor of dopamine receptor 2 (DRD2) signaling, in glioblastoma patients, Li et al, Saturday November 17th
DDIS-12 (Poster): ONC201: The first selective, non-competitive DRD2/3 antagonist for clinical neuro-oncology, Prabhu et al, Saturday November 17th
DDIS-16 (Poster): ONC201 in combination with radiation exhibits synergistic efficacy in high grade gliomas and other advanced cancers, Tarapore et al, Saturday November 17th
Utility of imipridone scaffold in neuro-oncology (3 abstracts)

EXTH-64 (Talk): Imipridones Cause Metabolic Reprogramming and Elicit Unique Vulnerabilities in Glioblastoma, Ishida et al, Friday November 16th, 8:06-8:10pm
EXTH-17 (Talk): Selective, non-competitive DRD2/3 antagonism by imipridone ONC206 is effective in tumors with dopamine receptor dysregulation, Prabhu et al, Friday November 16th, 8:02-8:06pm
EXTH-58 (Poster): ONC206, an imipridone family member, suppresses glioblastoma cells via blocking cancer stemness pathways, Jung et al, Saturday November 17th

On November 6, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the third quarter of 2018 and updated financial guidance for 2018 (Press release, Jazz Pharmaceuticals, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375661 [SID1234530760]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We delivered strong top-line and bottom-line growth in the third quarter and recently achieved two significant regulatory milestones, with the receipt of marketing authorization for Vyxeos in the EU and FDA approval of Xyrem for pediatric narcolepsy patients," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "In the U.S., we are reinforcing Vyxeos as essential therapy for secondary AML with increased education and outreach programs to address the complex and evolving marketplace for AML. As we approach year end, we are also focused on our remaining 2018 corporate goals, including our planned solriamfetol EU regulatory submission and expected FDA approval of solriamfetol."

GAAP net income for the third quarter of 2018 was $149.3 million, or $2.41 per diluted share, compared to $63.5 million, or $1.03 per diluted share, for the third quarter of 2017.

Adjusted net income for the third quarter of 2018 was $221.7 million, or $3.58 per diluted share, compared to $197.6 million, or $3.22 per diluted share, for the third quarter of 2017. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total revenues increased 14% in the third quarter of 2018 compared to the same period in 2017 due to the contribution of strong sales from Xyrem and Defitelio and the inclusion of a full quarter of Vyxeos sales.

Xyrem net product sales increased 18% in the third quarter of 2018 compared to the same period in 2017.

Erwinaze/Erwinase net product sales decreased 16% in the third quarter of 2018 compared to the same period in 2017. Ongoing supply challenges at the manufacturer, Porton Biopharma Limited, continue to negatively impact the company’s ability to provide patients with this important component of the treatment regimen for acute lymphoblastic leukemia. There is currently a global supply outage of Erwinaze, and the company expects further supply disruptions during the fourth quarter and into 2019.

Defitelio/defibrotide net product sales increased 16% in the third quarter of 2018 compared to the same period in 2017. The company continues to expect inter-quarter variability in Defitelio net sales given that hepatic veno-occlusive disease (VOD) is an ultra-rare disease.

Vyxeos net product sales were $21.0 million in the third quarter of 2018 compared to $9.7 million in the third quarter of 2017, which reflected the first six weeks of sales post-launch in August 2017. The company is implementing initiatives focused on establishing Vyxeos as essential therapy for patients with secondary acute myeloid leukemia (AML), as the company addresses challenges to wider adoption in a complex and evolving AML market.

Operating expenses changed over the prior year period primarily due to the following:

Selling, general and administrative (SG&A) expenses increased in the third quarter of 2018 compared to the same period in 2017 on a GAAP and on a non-GAAP adjusted basis due to higher expenses resulting from the expansion of the company’s business, including the rolling launch of Vyxeos in the EU and pre-launch activities for solriamfetol in anticipation of U.S. Food and Drug Administration (FDA) approval.
Research and development (R&D) expenses increased in the third quarter of 2018 compared to the same period in 2017 on a GAAP and on a non-GAAP adjusted basis due to an increase in expenses related to the company’s pre-clinical and clinical development programs and regulatory activities, including an increase in headcount to support these activities.
Acquired in-process research and development expense in the third quarter of 2017 related to an upfront payment of $75.0 million in connection with a collaboration and option agreement with ImmunoGen, Inc.
Cash Flow and Balance Sheet

As of September 30, 2018, cash, cash equivalents and investments were $1.1 billion and the outstanding principal balance of the company’s long-term debt was $1.8 billion. During the nine months ended September 30, 2018, the company generated $574.6 million of cash from operations, received a $50.0 million upfront payment for the sale of its rights to Prialt, purchased a priority review voucher for $110.0 million and used $77.0 million to repurchase approximately 500,000 ordinary shares under the company’s share repurchase program at an average cost of $154.03 per ordinary share. As of September 30, 2018, the remaining amount authorized under the share repurchase program was $106 million. In November 2018, the company’s board of directors increased the share repurchase program by $320 million.

Recent Developments

In August 2018, the company initiated the EU rolling launch of Vyxeos 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), following EU approval on August 23, 2018.

In September 2018, the company completed the sale of its rights to Prialt to TerSera Therapeutics LLC for a total purchase price of $80.0 million, of which the company received $50.0 million at closing and, subject to certain conditions, is scheduled to receive $15.0 million at the end of 2019 and $15.0 million at the end of 2020.

In September 2018, Nippon Shinyaku Co., Ltd. announced that Japan’s Ministry of Health, Labour and Welfare granted orphan drug designation to defibrotide sodium for the treatment of hepatic VOD following hematopoietic stem-cell transplantation, and, in October 2018, Nippon Shinyaku Co., Ltd. submitted a new drug application (NDA) in Japan.

In October 2018, the company announced the settlement of patent litigation against Amneal Pharmaceuticals LLC related to its abbreviated new drug application (ANDA) to market a generic version of Xyrem. This represents settlement of all outstanding patent litigation related to Xyrem.

In October 2018, the company received FDA approval of its supplemental NDA for Xyrem to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients and plans to launch in the first half of 2019.

Excludes $4-$8 million of share-based compensation expense from estimated GAAP gross margin.

Excludes $74-$82 million of share-based compensation expense and $57 million of estimated loss contingency from estimated GAAP SG&A expenses.

Excludes $17-$20 million of share-based compensation expense and $11 million of milestone payments from estimated GAAP R&D expenses.

Excludes the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income.

See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to Non-GAAP Adjusted 2018 Net Income Guidance" at the end of this press release.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EST (9:30 p.m. GMT) to provide a business and financial update and discuss its 2018 third quarter results. The live webcast may be accessed from the Investors section of the company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 8048589.

A replay of the conference call will be available through November 13, 2018 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 8048589. An archived version of the webcast will be available for at least one week in the Investors section of the company’s website at www.jazzpharmaceuticals.com.