On May 14, 2020 IntelGenx Technologies Corp. (TSX V:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") reported financial results for the first quarter ended March 31, 2020 (Press release, IntelGenx, MAY 14, 2020, View Source [SID1234558032]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2020 First Quarter Financial Summary:

Revenue was $202,000, compared to $416,000 in the 2019 first quarter
Adjusted EBITDA was ($1.9 million), compared to ($2.1 million) in Q1-2019
Cash and short-term investments totaled $4.4 million as at March 31, 2020
Recent Developments:

Announced a performance improvement program focused on generating near-term revenue, preserving the Company’s resources, extending its cash runway and accelerating the launch of RIZAPORT in Spain. The program also includes plans to meet with the U.S. Food and Drug Administration to discuss its recent Complete Response Letter – which requested additional information, but no new bioequivalence study – related to IntelGenx’s resubmitted 505(b)(2) New Drug Application for RIZAPORT.
Closed an offering of 16,317,000 units (the "Units") at a price of C$0.50 per Unit for gross proceeds of C$8,158,500.
Received a No Objection Letter from Health Canada in response to IntelGenx’s amended Clinical Trial Application for the ongoing Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease.
Announced that a cannabis-infused VersaFilm product has been finalized with its co-development partner, and all manufacturing scale-up work has been successfully completed.
Signed a binding term sheet with Orivas for the commercialization of RIZAPORT pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway).
"This quarter, we continued to make final preparations pending receipt of Health Canada’s micro-processing license, which is required to enable us to begin commercial production of cannabis-infused oral films for our partner," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We also implemented the previously announced performance improvement program, which includes measures to reduce expenses, optimize our organizational structure and extend our cash runway. The expense reduction initiatives include a 20% salary deferral by senior management, a 20% board fee reduction, the cancellation of DSU grants to directors, as well as staffing reductions of 10%. These were difficult, but necessary decisions aimed at maintaining our financial stability during this uncertain time, while better positioning the Company for future success."

Financial Results:

Total revenues for the three-month period ended March 31, 2020 amounted to $202,000, a decrease of $214,000 compared to $416,000 for the three-month period ended March 31, 2019. The decrease is mainly attributable to a $214,000 decrease in Research and Development ("R&D") revenues.

Operating costs and expenses were $2.4 million for the first quarter of 2020, versus $2.7 million for the corresponding three-month period of 2019. The decrease for the three-month period ended March 31, 2020 is mainly attributable to a $10,000 decrease in R&D expenses and a $380,000 decrease in Selling, General and Administrative expenses.

For the first quarter of 2020, the Company had an operating loss of $2.2 million, compared to an operating loss of $2.3 million for the comparable period of 2019.

Net comprehensive loss for the three-month period ended March 31, 2020 was $2.9 million, or $0.03 per basic and diluted share, compared to net comprehensive loss of $2.3 million, or $0.03 per basic and diluted share, for the comparable period of 2019.

As at March 31, 2020, the Company’s cash and short-term investments totalled $4.4 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2020 first quarter financial results today, Thursday, May 14, 2020, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 9608388. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.

On May 14, 2020 Incyte (Nasdaq: INCY) reported that multiple abstracts highlighting data from clinical trials of medicines that are being developed in-house and through partnerships with Novartis, MorphoSys and Takeda will be presented at the upcoming 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Meeting (ASCO20; May 29 – May 31); and at the virtual 25thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25; June 11 – 14) (Press release, Incyte, MAY 14, 2020, View Source [SID1234558031]).

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"We are pleased to have virtual platforms such as ASCO (Free ASCO Whitepaper)20 and EHA (Free EHA Whitepaper)25 to continue sharing important data with the scientific community in a timely manner," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These data demonstrate the strength of our broad oncology portfolio and our partnerships; and reinforce our commitment to finding solutions that can help meet patients’ needs."

Key abstracts accepted by ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include:

ASCO Abstracts

Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at ASCO (Free ASCO Whitepaper) will be available on demand beginning Friday, May 29, 2020, 8:00 AM ET.

Oral Presentations

Capmatinib in Patients with High-Level MET-Amplified Advanced Non-Small Cell Lung Cancer (NSCLC): Results from the Phase 2 GEOMETRY mono-1 Study(Abstract #9509, Session: MET Mutations: The Meat of the Matter)1

Interim Analysis (IA) of OPTIC: A Dose-Ranging Study of Three Ponatinib (PON) Starting Doses (Abstract #7502, Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant)2

E-Poster Presentations

An Independent Review of Arterial Occlusive Events (AOEs) in the Ponatinib (PON) Phase 2 PACE Trial (NCT01207440) in Patients (pts) with Ph+ Leukemia (Abstract #7550, Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant)2

Re-MIND Study: A Propensity Score-Based 1:1 Matched Comparison of Tafasitamab + Lenalidomide (L-MIND) Versus Lenalidomide Monotherapy (Real-World Data) in Transplant-Ineligible Patients with Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) (Abstract #8020, Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia)3

Safety and Efficacy of Pemigatinib Plus Pembrolizumab Combination Therapy in Patients (pts) with Advanced Malignancies: Results from FIGHT-101, an Open-Label Phase 1/2 study (Abstract #3606, Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology)

Capmatinib in Patients with METex14-Mutated or High-Level MET-Amplified Advanced Non-Small-Cell Lung Cancer (NSCLC): Results from Cohort 6 of the Phase 2 GEOMETRY mono-1 study (Abstract #9520, Session: Lung Cancer—Non-Small Cell Metastatic)1

Pan-Cancer Analysis of FGFR1-3 Genomic Alterations to Reveal a Complex Molecular Landscape (Abstract #3620, Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology)

EHA Abstracts

Oral abstract presentations and e-posters accepted for presentation at EHA (Free EHA Whitepaper) will be available on the on-demand Virtual Congress platform beginning Friday, June 12, 2020, at 8:30 AM CEST.

Oral Presentations

Addition of Parsaclisib, a PI3Kδ inhibitor, in Patients with Suboptimal Response to Ruxolitinib (Rux): A Phase 2 Study in Patients (Pts) with Myelofibrosis (MF) (Abstract #S216, Session: Novel Therapies and Pitfalls in MPN)

Ruxolitinib Versus Best Available Therapy in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease: Overall Response Rate by Baseline Characteristics in the Randomized Phase 3 REACH2 Trial (Abstract #S255, Session: Stem Cell Transplantation – Clinical: Graft-Versus-Host Disease)1

GRAVITAS-301: A Randomized, Double-Blind Phase 3 Study of Itacitinib or Placebo in Combination with Corticosteroids for Initial Treatment of Patients with Acute Graft-Versus-Host Disease (Abstract #S256, Session: Stem Cell Transplantation – Clinical: Graft-Versus-Host Disease)

Interim Analysis from the OPTIC Trial, a Dose-Ranging Study of 3 Starting Doses of Ponatinib (Abstract #S172, Session: Chronic Myeloid Leukemia (CML) Clinical)2

Re-MIND Study: Comparison of Tafasitamab + Lenalidomide (L-Mind) vs Lenalidomide Monotherapy (Real-World Data) in Transplant-Ineligible Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract #S238, Aggressive Lymphomas: Observational Studies)3

E-Poster Presentations

Real-World Survival in Elderly Patients with Myelofibrosis in the United States: Ruxolitinib Exposed vs Unexposed (Abstract #EP1124, Session: Myeloproliferative Neoplasms – Clinical)

Real-World Survival in Elderly Patients with Myelofibrosis in the United States: Pre- vs Post-Ruxolitinib Approval (Abstract # EP1120, Session: Myeloproliferative Neoplasms – Clinical)

Machine-Learning to Predict Hydroxyurea (HU) Failure and Incidence of Thromboembolic Events (TEs) with HU vs Ruxolitinib Switch Therapy in Polycythemia Vera Patients (Abstract #EP1117, Session: Myeloproliferative Neoplasms – Clinical)1

Patient-Reported Physical, Emotional and Economic Impact of Myeloproliferative Neoplasms in an Expansion of the MPN Landmark Survey(Abstract #EP1112, Session: Myeloproliferative Neoplasms – Clinical)1

Ruxolitinib in PV Patients Resistant and/or Intolerant to Hydroxyurea: Interim Analysis of a European Multi-Centric Observational Study (Abstract #EP1115, Session: Myeloproliferative Neoplasms – Clinical)1

Treatment and Disease Management Practices in Patients with MPNs in 6 Countries: An Expansion of the MPN Landmark Survey(Abstract #EP1123, Session: Myeloproliferative Neoplasms – Clinical)1

Retrospective Independent Review of Arterial Occlusive Events (AOEs) in the Phase 2 PACE Trial of Ponatinib in Philadelphia Chromosome Positive (Ph+) Leukemia (Abstract #EP759, Session: Chronic Myeloid Leukemia (CML) Clinical)2

The Real–Life Study Evaluating the Efficacy and Safety of Ponatinib "Topase" Reveals Induction of Deep Molecular Responses in a Cohort of 75 TKI-Resistant or Intolerant patients with CML (Abstract #EP765, Session: Chronic Myeloid Leukemia (CML) Clinical)

Combination of Tafasitamab (MOR208) and Lenalidomide Enhances Tumor Cell Death of B-cell Lymphoma in Vitro (Abstract #EP1343, Session: Lymphoma Biology & Translational Research)3

Long-Term Outcomes from the Phase II L-MIND Study of Tafasitamab (Mor208) Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (Abstract #EP1201, Session: Aggressive Non-Hodgkin Lymphoma – Clinical)3

Expression of CD19 Antigen on Chronic Lymphocytic Leukemia Cells After Tafasitamab (Anti-CD19) Treatment: Phase I Trial Data (Abstract #EP671, Chronic Lymphocytic Leukemia and Related Disorders – Biology & Translational Research)3

For full session details and data presentation listings, please see the ASCO (Free ASCO Whitepaper)20 (View Source) and EHA (Free EHA Whitepaper)25 (View Source) online programs.

On May 14, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported that it has been selected to deliver a poster presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, to be held virtually during May 29 – 31, 2020 (Press release, Heat Biologics, MAY 14, 2020, View Source [SID1234558030]). The ASCO (Free ASCO Whitepaper) Annual Meeting is the largest international conference to showcase the latest advancement in oncology. The abstracts published in advance of the ASCO (Free ASCO Whitepaper) Annual Meeting were made available at 5:00 p.m. Eastern Daylight Time on May 13, 2020 on the ASCO (Free ASCO Whitepaper) meeting website at: View Source

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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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HS-110 is currently in Phase 2 trial in combination with Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer (NSCLC). HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients’ immune system against multiple tumor antigens to elicit a robust pan-antigen T-cell attack against tumor cells. Heat completed enrollment in this trial in July 2019.

The abstract provides an update on the efficacy data of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC. The median overall survival (OS) was 28.7 months with a median follow up of 15.7 months. This study is ongoing and 21 of the 47 patients enrolled (45%) were still alive as of this datacut. Additional subset analysis will also be presented. HS-110 has a good safety profile in over 200 patients and combination of HS-110 and nivolumab appears to be safe and well-tolerated.

Exploratory biomarker analysis on cancer testis antigens (CTAs) was performed using patients’ tumor tissue at baseline. In this evaluation, improved overall survival (OS) was observed in patients whose tumors have 8 or more overlapping CTAs with the 39 CTAs overexpressed by HS-110. In addition, overexpression of zinc finger protein 492 (ZNF492) was associated with greater OS. ZNF492 is a transcription factor that is expressed in multiple cancers.

Details of Heat Biologics’ ASCO (Free ASCO Whitepaper) poster presentation:

Abstract Title: Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab

Session: Lung Cancer – Non-Small Cell Metastatic
Abstract #: 9546
Poster#: 312
Date: Friday, May 29, 2020, 8am Eastern Time

Following the presentation, a copy of the poster will be available on Heat Biologics’ website at: View Source

Reference:

The Human Protein Atlas – ZNF492: View Source

On May 14, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the company will receive a $15 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered under the Collaboration and License Agreement between the two companies (Press release, Halozyme, MAY 14, 2020, View Source [SID1234558029]). The milestone payment is associated with the first commercial sale in the United States of Janssen’s DARZALEX FASPROTM (daratumumab and hyaluronidase – fihj) utilizing ENHANZE, which was recently approved by the U.S. Food and Drug Administration.

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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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On May 14, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it will present novel immuno-oncology data from the selective cortisol receptor modulator relacorilant at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Corcept Therapeutics, MAY 14, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-present-data-american-society-clinical [SID1234558028]). This year’s annual meeting will be held in a virtual format from Friday, May 29 through Sunday, May 31, 2020. Following its presentation, a copy of our poster will be available at the Research & Pipeline / Publications tab of our website.

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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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"Patients with adrenal cancer often have tumors that produce cortisol, which may limit the efficacy of immune checkpoint inhibitors," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Our hypothesis is that administering a selective cortisol modulator in combination with an immunotherapeutic agent such as pembrolizumab will treat the symptoms of hypercortisolism and help pembrolizumab achieve its maximum effect.1 The data presented in this abstract have informed the design of our Phase 1b trial in which 20-patients with metastatic or unresectable adrenal tumors that produce cortisol will receive our selective cortisol modulator relacorilant in addition to pembrolizumab."

Impact of relacorilant, a selective glucocorticoid receptor antagonist,
on the immunosuppressive effects of endogenous cortisol (abstract no. 3091)

Session Title: Developmental Therapeutics – Immunotherapy
Session Type: Poster session
Location: Virtual meeting
Presentation Available Online: May 29 to November 20, 2020 (meeting registration required)
About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body’s other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing’s syndrome and advanced adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents through 2037. Relacorilant has received orphan designation in the United States for the treatment of both Cushing’s syndrome and pancreatic cancer.