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IntelGenx Reports Third Quarter 2019 Financial Results

On November 7, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the third quarter ended September 30, 2019 (Press release, IntelGenx, NOV 7, 2019, View Source [SID1234550612]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2019 Third Quarter Financial Summary:

Revenue was $61,000, compared to $700,000 in the third quarter of 2018
Adjusted EBITDA was ($2.3 million), unchanged from Q3-2018
Cash and short-term investments totaled $4.3 million as at September 30, 2019 compared to $2.2 million as at September 30, 2018
Recent Developments:

Received approval for prototype cannabis-infused VersaFilm product from co-development partner, Tilray (NASDAQ:TLRY), and initiated manufacturing scale-up work
Announced that its 505(b)(2) New Drug Application ("NDA") for RIZAPORT VersaFilm for the treatment of acute migraines was accepted for review by the U.S. Food and Drug Administration ("FDA") and that the FDA assigned a March 26, 2020, Prescription Drug User Fee Act ("PDUFA") goal date for completion of the review
Received a positive Data Safety Monitoring Board recommendation that the Company’s Montelukast VersaFilm Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease continue
Presented an overview of the Company’s business at the H.C. Wainwright 21st Annual Global Investment Conference
"In many respects, we are now just nearing the starting line with the anticipated commercialization of our two lead VersaFilm products," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "The initiation of scale-up work for the cannabis-infused VersaFilm product we are co-developing with our worldwide partner, Tilray, and receipt of a PDUFA goal date for completion of the FDA’s review of the RIZAPORT NDA, mark important milestones. We are looking forward to unveiling details about our cannabis-infused oral film as we approach product launch, and as always, to updating our stakeholders as we continue to make progress toward bringing our VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended September 30, 2019 amounted to $61,000, compared to $700,000 for the three-month period ended September 30, 2018. The decrease is mainly attributable to a $639,000 decrease in Research and Development ("R&D") revenues.

Operating costs and expenses were $2.6 million for the third quarter of 2019, versus $3.3 million for the corresponding three-month period of 2018. The decrease for the three-month period ended September 30, 2019 is mainly attributable to a $610,000 decrease in R&D expenses and a $153,000 decrease in Selling, General and Administrative expenses.

For the third quarter of 2019, the Company had an operating loss of $2.5 million, compared to an operating loss of $2.6 million for the comparable period of 2018.

Net comprehensive loss for the three-month period ended September 30, 2019 was $2.9 million, or $0.03 on a basic and diluted per share basis, compared to $3.0 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.

As of September 30, 2019, the Company’s cash and short-term investments totalled $4.3 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 third quarter financial results today 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 5068946. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

Spectrum Pharmaceuticals Reports Third Quarter 2019 Financial Results and Pipeline Update

On November 7, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended September 30, 2019 (Press release, Spectrum Pharmaceuticals, NOV 7, 2019, View Source [SID1234550611]).

"Spectrum has an expanding pipeline, significant near-term milestones, solid capitalization and a highly focused team," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "In December, we look forward to results from Cohort 1 of our ZENITH20 study investigating poziotinib in lung cancer patients with hard-to-treat mutations. We recently submitted our BLA for ROLONTIS to the FDA, a key milestone, as we continue to execute on our strategic priorities."

Pipeline Updates

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Topline results from the EGFR previously treated non-small cell lung cancer cohort (Cohort 1) in the ZENITH20 trial are expected in December. These data could potentially support a New Drug Application (NDA) filing with the FDA.
The HER2 previously-treated non-small cell lung cancer cohort (Cohort 2) of the ZENITH20 trial is fully accrued and is expected to have topline results by mid-year 2020. This cohort also has the potential to support an NDA filing with the FDA in the future.
A basket study has been initiated to investigate poziotinib in patients with EGFR or HER2 mutation-positive malignant solid tumors in an investigator-led study, with the first patient enrolled at The University of Texas MD Anderson Cancer Center.
In September, new preclinical data from The University of Texas MD Anderson Cancer Center, was presented during the IASLC 2019 World Conference on Lung Cancer in Barcelona, Spain. These scientific data support the recently announced expansion of the ZENITH20 trial.
ROLONTIS (eflapegrastim), a novel long-acting GCSF

Spectrum submitted the ROLONTIS BLA to the FDA on October 24, 2019.
In October, Spectrum presented a poster at the ASCO (Free ASCO Whitepaper) Supportive Care in Oncology Symposium in San Francisco, CA, highlighting integrated efficacy data from the Phase 3 ROLONTIS clinical trials, ADVANCE and RECOVER which studied more than 600 patients combined and met all primary and secondary endpoints.
Integrated safety data from the ROLONTIS studies will be presented at the San Antonio Breast Cancer Symposium meeting in December.
Three-Month Period Ended September 30, 2019 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a loss of $26.6 million, or $0.24 loss per basic and diluted share, in the three-month period ended September 30, 2019, compared to net loss of $69.2 million, or $0.66 loss per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $17.2 million in the quarter, as compared to $15.3 million in the same period in 2018. Selling, general and administrative expenses were $13.1 million in the quarter, compared to $13.1 million in the same period in 2018.

The company ended the quarter with cash, cash equivalents, restricted cash, and marketable securities of $252 million.

Non-GAAP Results

Spectrum recorded a non-GAAP loss of $24.5 million, or a non-GAAP loss of $0.22 per basic and diluted share, in the three-month period ended September 30, 2019, compared to a non-GAAP loss of $25.3 million, or a non-GAAP loss of $0.24 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $16.1 million, as compared to $14.7 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $9.9 million, as compared to $11.1 million in the same period in 2018.

Conference Call:

Thursday, November 7, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 1469173
International: (973) 796-5077, Conference ID# 1469173

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on November 7, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

Enterome enters research collaboration with major cancer center focused on new microbiome-derived immunotherapies

On November 7, 2019 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the key functional and molecular interactions between the gut microbiome and the human body to develop targeted therapeutics, reported that has entered into a research collaboration with Memorial Sloan Kettering Cancer Center (MSK) in New York City to evaluate the potential of gut microbiome-derived antigens for development as cancer immunotherapies (Press release, Enterome, NOV 7, 2019, View Source [SID1234550610]).

Enterome is pioneering an innovative approach to cancer immunotherapy based on the concept of "molecular mimicry", whereby microbiome-derived bacterial antigens that show molecular similarity with Tumor-associated Antigens (TAAs) and Tumor-specific Neoantigens (TSNAs) are used to trigger tumor-specific cytotoxic T cell immune responses. The Company refers to these bacterial antigens as "onco-mimics."

Enterome has developed its proprietary Onco-Mimics discovery platform to identify such antigens from the human gut microbiome and has advanced EO2401 as its first clinical candidate. EO2401 comprises several microbiome-derived antigens that mimic those that are selectively over-expressed by a number of solid tumors. The Company aims to develop EO2401 as a potential new immunotherapy for several indications, with an initial focus on recurrent glioblastoma multiforme (GBM), a devastating cancer for which no curative treatments exist. The first clinical trial is targeted to start by the end of 2019.

This new research collaboration aims to generate further evidence to support Enterome’s Onco-Mimics immunotherapy platform and will look at validating its application in several tumor types including melanoma, lung and pancreatic. Enterome will bring its ability to identify potential TAAs and TSNAs as well as to generate onco-mimics derived from the microbiome for the selected TAAs and TSNAs and will work with leading cancer experts within the Ludwig Center for Cancer Immunotherapy and the David M. Rubenstein Center for Pancreatic Cancer Research, both at MSK.

"We are excited to initiate this new collaboration with Memorial Sloan Kettering Cancer Center, which following the start of our collaboration with Dana-Farber Cancer Institute earlier this year, means we are now working closely with experts at two of the world’s leading cancer research centers to further the understanding of our immunotherapy approach and validate our unique Onco-Mimics discovery platform," said Christophe Bonny, CSO of Enterome. "We believe that this cutting-edge research will provide a solid scientific foundation that will enable us to further develop our pipeline of new immunotherapy candidates for multiple cancer indications."

Taha Merghoub PhD Biologist at MSK commented, "The microbiome concept presents an exciting new approach to the development of cancer immunotherapies and our understanding of how the microbiome works keeps improving with emerging data highlighting the important link between the microbiome and the effectiveness of immunotherapies."

Arvinas, Inc. Announces Pricing of Public Offering of Common Stock

On November 7, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported the pricing of an underwritten public offering of 4,545,455 shares of its common stock at a price of $22.00 per share, before underwriting discounts and commissions (Press release, Arvinas, NOV 7, 2019, View Source [SID1234550606]). In addition, Arvinas has granted the underwriters an option for a period of 30 days to purchase up to an additional 681,818 shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares are being offered by Arvinas.

Goldman Sachs & Co. LLC, Citigroup and Piper Jaffray & Co. are acting as joint book-running managers for the offering. The offering is expected to close on or about November 12, 2019, subject to customary closing conditions.

A shelf registration statement on Form S-3 (File No. 333-234035) relating to the shares of common stock offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on October 10, 2019. The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 800-831-9146; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at [email protected].

This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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.

Sierra Oncology and Gilead Sciences Agree on Amendments to Asset Purchase Agreement for Momelotinib

On November 7, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that it has agreed to amend its Asset Purchase Agreement with Gilead Sciences, Inc. for momelotinib upon Sierra closing a qualified financing (Press release, Sierra Oncology, NOV 7, 2019, View Source [SID1234550605]).

"These are significant amendments that meaningfully enhance the potential long-term value of momelotinib for Sierra and its stockholders. The amendments also affirm Gilead’s support for the continued development of momelotinib with the goal of bringing meaningful benefit to patients with myelofibrosis," said Dr. Nick Glover, President and CEO of Sierra Oncology. "Following the closing by Sierra of a qualified financing, Gilead will become a stockholder in Sierra, the annual royalty rates payable to Gilead will be reduced, which will benefit the company and all its stockholders should momelotinib prove commercially successful, and we will also eliminate a milestone payment that would be due to Gilead in the coming months with the anticipated initiation of the MOMENTUM Phase 3 trial for momelotinib, further extending our financial resources."

"We are pleased to enter into this amended agreement with Sierra in order to support the company’s continued advancement of momelotinib. Gilead continues to believe in the potential of momelotinib, and we are pleased that Sierra will continue development of the compound in hopes that it will benefit patients in the future," said Andrew Dickinson, Chief Financial Officer of Gilead.

In consideration for amending the royalty rates and milestones in the Asset Purchase Agreement, following the automatic conversion of shares of preferred stock to be issued in connection with Sierra’s recently announced financing, Sierra and Gilead Sciences would enter into a Securities Purchase Agreement, pursuant to which Sierra would issue to Gilead Sciences shares of Sierra Common Stock and a warrant to purchase Sierra Common Stock. The number of shares of Common Stock to be issued would be equal to 7.5% of Sierra’s outstanding shares of Common Stock, after giving effect to certain adjustments related to the financing. The Warrant would be exercisable to purchase up to an additional 7.5% of Sierra’s outstanding shares of Common Stock. The Warrant would include a blocker provision, that may be waived by Gilead upon specified notice, that prevents Gilead from exercising the warrant for a number of shares that would result in Gilead owning more than 9.99% of Sierra’s issued and outstanding shares of Common Stock.