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 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases ("TG Therapeutics"), reported that it intends to offer and sell 6,000,000 shares of its common stock in an underwritten public offering (Press release, TG Therapeutics, MAY 14, 2020, View Source [SID1234558048]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.

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TG Therapeutics intends to use the net proceeds of the public offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes.

J.P. Morgan Securities LLC, Jefferies LLC Evercore Group L.L.C., and Cantor Fitzgerald & Co. are acting as joint book-running managers for the proposed offering.

The public offering of common stock is being made pursuant to an automatically effective shelf registration statement previously filed with the SEC on September 5, 2019. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (866) 803-9204, or email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or by email at [email protected]; Evercore Group L.L.C, Attention: Equity Capital Markets, 55 East 52nd Street, 37th Floor, New York, NY 10055, by telephone at (888) 474-0200, or email: [email protected]; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 14, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) reported updated results from the ongoing Phase 2 L-MIND study investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Press release, MorphoSys, MAY 14, 2020, View Source [SID1234558065]). The results, based on a November 30, 2019 data cut-off, corroborate previously reported primary analysis data.

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In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis. After a minimum of two years’ follow-up, outcomes from the L-MIND study are consistent with the primary analysis and confirm the durability of the response (DoR) and overall survival (OS) of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in autologous stem cell transplantation (ASCT)-ineligible patients with r/r DLBCL. Assessment by an independent review committee (IRC) at data cut-off showed an objective response rate (ORR) of 58.8% (47 out of 80 patients) and a complete response (CR) rate of 41.3% (33 out of 80 patients). Median duration of response (mDOR) was 34.6 months, with median overall survival (mOS) of 31.6 months and median progression-free survival (mPFS) of 16.2 months. The safety profile was consistent with that observed in previously reported studies of tafasitamab in combination with lenalidomide. The full analysis will be presented virtually at the 25th EHA (Free EHA Whitepaper) Annual Congress to be held June 11-14, 2020.

"We are extremely encouraged by the long-term data from our L-MIND study which confirms the previously reported results from the primary analysis," commented Dr. Malte Peters, Chief Research and Development Officer, MorphoSys. "Tafasitamab in combination with lenalidomide has the potential to address the significant medical need in patients suffering from r/r DLBCL, and we are working diligently towards our key priority of making tafasitamab available to eligible patients."

"The updated data for L-MIND reinforce the potential of tafasitamab in combination with lenalidomide as treatment for patients with r/r DLBCL. We look forward to working with our partners at MorphoSys as we seek to bring this new therapeutic option to eligible patients globally," Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte.

A Biologics License Application (BLA) for tafasitamab in combination with lenalidomide for r/r DLBCL is currently under Priority Review by the U.S. Food and Drug Administration (FDA) (PDUFA action date August 30, 2020). The BLA is based on data including the primary analysis of L-MIND with a previous cut-off date as of November 30, 2018, and the primary analysis data from the retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received lenalidomide monotherapy.

In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States while Incyte has exclusive commercialization rights outside the United States.

About L-MIND
L-MIND is a single arm, open-label Phase 2 study, investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study’s primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Primary analysis data with a cut-off date of November 30, 2018 included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update were based on response rates assessed by an independent review committee for all 80 patients.

About Re-MIND
Re-MIND, an observational retrospective study, was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’ L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.

About tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved in the U.S., MorphoSys and Incyte will co-commercialize tafasitamab; Incyte will have exclusive commercialization rights outside the U.S. Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND. Additionally, tafasitamab is being evaluated as part of the ongoing Phase 3 study B-MIND study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. Tafasitamab is also currently being investigated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On May 14, 2020 NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, reported plans for a Phase 2, randomized, open-label study to evaluate the efficacy and safety of their combination immunotherapy: NantKwest’s PD-L1 t-haNK, ImmunityBio’s N-803, and aldoxorubicin HCI plus standard of care, versus standard-of-care chemotherapy for first- and second-line treatment of locally advanced or metastatic pancreatic cancer (Press release, NantKwest, MAY 14, 2020, View Source [SID1234558081]).

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Four metastatic pancreatic cancer patients have been treated with PD-L1 t-haNK and N-803 under single patient INDs, with two patients on treatment for an evaluable period. One patient reported ongoing, durable, complete response six months after treatment, and one observed response of stable disease. The Investigational New Drug (IND) application has received authorization from the U.S. Food and Drug Administration (FDA) with the study anticipated to begin in June 2020.

"Our results from expanded access use of PD-L1 t-haNK in combination with N-803 offer proof-of-concept that, together with these agents, the immune system may play a role to activate robust and durable responses in metastatic cancer patients who have failed all standard-of-care therapies," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. "Based on these encouraging data, we are moving forward with a randomized Phase 2 program that will evaluate our immunotherapy combination on top of standard of care, compared to standard of care alone, in first- and second-line treatment settings. This unique approach to orchestrating the innate and adaptive immune systems to induce immunogenic cell death may be an important new approach for pancreatic cancer patients—these being among the most challenging to treat with poor prognoses."

"Abraxane, a protein-based nanoparticle that activates macrophages, was our first evolution in making an impact on pancreatic cancer. With this addition of PD-L1 t-haNK and N-803, we are hopeful that we can proceed to the next step of long-term remission in this difficult to treat disease. Adding a natural killer cell with a checkpoint via PD-L1 t-haNK and activating memory T cells via N-803 will complete the ‘triangle offense’ we are orchestrating. The early results of complete response in one patient using the therapy on a compassionate use basis is encouraging and we are excited to initiate this trial involving other patients who suffer from pancreatic cancer," he said.

Study Details:

This Phase 2, randomized, two-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with PD-L1 t-haNK, N-803, and aldoxorubicin HCl in subjects with locally advanced or metastatic pancreatic cancer (QUILT-88). Each treatment setting, and first- and second-line or later maintenance, will be evaluated independently as Cohort A and Cohort B, respectively, with each Cohort having independent experimental and control arms. The study will initially enroll 268 subjects across both cohorts with the primary objective of comparative efficacy by progression free survival (PFS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Pancreatic cancer kills an estimated 47,000 people annually; it is the fourth leading cause of cancer-related death in the U.S., and 57,600 new cases are expected in 2020. Less than 5% of these patients will live for more than five years after diagnosis, and the median survival prognosis is 5 to 8 months.

On May 14, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that they will present new data from its ongoing clinical research evaluating the MammaPrint and BluePrint genomic tests at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place virtually May 29-May 31, 2020 (Press release, Agendia, MAY 14, 2020, View Source [SID1234558097]).

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Data will underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for patients throughout their treatment journey. This data builds upon existing clinical research that demonstrates the efficacy of Agendia’s MammaPrint and BluePrint testing to consistently inform optimal treatment planning.

Specific data selected for presentation will include: an evaluation of the concordance between human epidermal growth factor receptor 2 (HER2) status as put forth by the 2018 ASCO (Free ASCO Whitepaper)/CAP guideline classification and BluePrint genomic testing; an examination of specific oncogenes and their correlation with risk scoring and molecular subtyping results; the ability of a chemokine gene score and MammaPrint to predict pathologic complete response (pCR) following neoadjuvant chemotherapy.

Two other poster presentations will feature additional data sets from Agendia’s ongoing multicenter, prospective, observational trial for patients with Stage I, II, and III breast cancer (FLEX). Researchers will share data from FLEX analyses evaluating triple negative breast cancers (TNBC), as well as the clinical estrogen receptor status of Basal-Type tumors based on self-reported patient ethnicities, new gene expression profiles and investigator-initiated protocols in early stage breast cancer.

"Our MammaPrint and BluePrint assays have demonstrated the ability to uniquely guide the practice of precision oncology in helping patients and their healthcare providers create the most targeted and appropriate treatment plan," says William Audeh, MD, MS, chief medical officer at Agendia. "We continue to investigate biologic drivers of breast cancer to help reduce uncertainty when choosing a treatment regimen and these latest data sets offer additional clinical insights that we believe can translate to improved patient outcomes."

Following are details of the five Agendia abstracts that have been accepted for poster presentations at the 2020 ASCO (Free ASCO Whitepaper) Annual Congress:

TNBC subtype and clinical estrogen receptor status of genomically basal breast tumors in Caucasian, African American, and Latin American patients
Authors: Kaklamani, V., et al.
Session: Breast Cancer—Local/Regional/Adjuvant
Abstract #: 556

The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer
Authors: D’Abreo, N., et al.
Session: Health Services Research and Quality Improvement
Abstract #: TPS7088

High Risk breast cancer genes at 8q22-24 and their role in over 5000 patients evaluated with the 70-gene risk of recurrence assay
Authors: Diab, S., et al.
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract #: 3569

Adding precision to 2018 ASCO (Free ASCO Whitepaper)/CAP HER2 testing guidelines in breast cancer with genomic profiling
Authors: Brufsky, A., et al.
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract #: 3570

12-chemokine gene expression score in breast cancer patients treated with neoadjuvant chemotherapy
Authors: Soliman, H., et al.
Session: Breast Cancer—Local/Regional/Adjuvant and Developmental Therapeutics—Immunotherapy
Abstract #: 591

In addition, the European Organisation for Research and Treatment of Cancer (EORTC) will be presenting nearly nine year follow-up data from the landmark MINDACT study. The independent trial, originally published in the New England Journal of Medicine in 2016, confirmed the clinical utility of MammaPrint as a prognostic tool in identifying genomic Low Risk patients who do not significantly benefit from chemotherapy.

Please follow us on our Twitter, Facebook and LinkedIn pages for unique content we will be sharing throughout ASCO (Free ASCO Whitepaper).

The ASCO (Free ASCO Whitepaper) 2020 virtual program can be found in our Resources section of our website.