On July 31, 2019 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results and provided a business update for the three months ended June 30, 2019 (Press release, Lexicon Pharmaceuticals, JUL 31, 2019, View Source;2019.htm [SID1234537937]).

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"We are pleased that recent preliminary results of three Phase 3 clinical trials support the potential benefits Zynquista may bring to people with type 2 diabetes and particularly those with chronic kidney disease," said Lonnel Coats, Lexicon’s president and chief executive officer. "We are disappointed in Sanofi’s announcement of its purported termination of our alliance but are encouraged by the results that we have received thus far. We expect the balance of the core Phase 3 studies will be completed this year. As for our XERMELO business, we saw 24% growth in XERMELO net sales in the U.S. in the second quarter of 2019 versus the same period in 2018 and continue to make good progress on that front while effectively managing our resources and spend."

Second Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl)

· XERMELO U.S. net sales were $7.4 million in the second quarter of 2019.
· The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer, continues to enroll patients.

Zynquista (sotagliflozin)

· In April, the European Commission granted marketing authorization for Zynquista in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.

Second Quarter 2019 Financial Highlights

Revenues: Revenues for the three months ended June 30, 2019 decreased to $9.7 million from $13.8 million for the corresponding period in 2018, primarily due to lower revenues recognized from our collaboration and license agreement with Sanofi, partially offset by an increase in net product revenues. Net product revenues for the three months ended June 30, 2019 included $7.4 million from net sales of XERMELO in the U.S. and $1.3 million from the sales of bulk XERMELO tablets to Ipsen, cumulatively up 19% from the prior year quarter.

Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended June 30, 2019 and 2018 was $1.3 million and $0.8 million, respectively.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended June 30, 2019 decreased to $12.6 million from $26.5 million for the corresponding period in 2018, primarily due to lower external clinical development costs relating to Zynquista.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended June 30, 2019 decreased to $14.3 million from $16.8 million for the corresponding period in 2018, primarily due to decreased marketing costs.

Net Loss: Net loss for the three months ended June 30, 2019 was $23.0 million, or $0.22 per share, compared to a net loss of $34.5 million, or $0.33 per share, in the corresponding period in 2018. For the three months ended June 30, 2019 and 2018, net loss included non-cash, stock-based compensation expense of $3.8 million and $2.9 million, respectively.

Cash and Investments: As of June 30, 2019, Lexicon had $106.0 million in cash and investments, as compared to $160.1 million as of December 31, 2018.

Anticipated Near-Term Milestones

· September 2019 – Presentation of new analyses from pivotal studies of Zynquista in type 1 diabetes at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD)
· 2H 2019 – Topline Phase 1b data for LX9211
· 2H 2019 – Topline results from core Phase 3 studies for Zynquista in type 2 diabetes
· 2H 2019 – Completion of patient enrollment of the initial safety cohort in the Phase 2 study of telotristat ethyl in biliary tract cancer

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 5789855. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

XERMELO (telotristat ethyl) Important Safety Information

· Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
· Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
· Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.
For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

About Zynquista (sotagliflozin)

Discovered using Lexicon’s unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

Lexicon has granted Sanofi an exclusive worldwide (excluding Japan) license to develop, manufacture and commercialize Zynquista. Lexicon remains responsible for all clinical development activities relating to type 1 diabetes and Sanofi is responsible for all clinical development activities of Zynquista for the treatment of type 2 diabetes. Sanofi has delivered to Lexicon a notice purporting to terminate the alliance. Lexicon has notified Sanofi that it considers the notice invalid and Sanofi to be in breach of contract.

On July 31, 2019 Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its common stock will begin trading on the Nasdaq Capital Market under the symbol "XCUR" at the opening of trading on July 31, 2019, following its previously announced approval to list its common stock on the Nasdaq Capital Market (Press release, Exicure, JUL 31, 2019, View Source [SID1234537956]).

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Exicure also announced today the pricing of the previously announced underwritten public offering of 27,500,000 shares of its common stock at a price to the public of $2.00 per share. Exicure has also granted the underwriters a 30-day option to purchase up to an additional 4,125,000 shares of common stock to cover overallotments, if any. The offering is expected to close on or about August 2, 2019 subject to customary closing conditions.

Exicure expects to receive gross proceeds of $55 million from the sale of common stock in the offering, prior to deducting the underwriting discounts and commissions and estimated offering expenses payable by it. Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to develop an SNA therapeutic candidate for a neurology condition and advance it into Phase 1 clinical trials; and for general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering. Chardan is acting as lead manager for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann are acting as co-managers for the offering.

The securities described above are being offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at www.sec.gov. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, from: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

This press release does not constitute an offer to sell or the 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 that state or jurisdiction.

On July 31, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported it intends to release its second quarter 2019 financial results before markets open on Wednesday, August 14, 2019 (Press release, Nuvo Pharmaceuticals, JUL 31, 2019, View Source [SID1234537973]).

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The Company will subsequently hold a conference call that same day, Wednesday, August 14, 2019 at 8:30 a.m. ET, hosted by Jesse Ledger, Nuvo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.

CONFERENCE CALL DETAILS

DATE:

Wednesday, August 14, 2019

TIME:

8:30 a.m. ET

DIAL-IN NUMBER:

416 764 8688 or 888 390 0546

TAPED REPLAY:

416 764 8677 or 888 390 0541 / REPLAY PASSCODE: 509912 #

The audio webcast can be accessed at:

View Source

An archived replay of the webcast will be available by clicking the link above.

On July 31, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported it has achieved two-thirds enrollment in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed MGMT-unmethylated GBM (Press release, DelMar Pharmaceuticals, JUL 31, 2019, View Source [SID1234537941]). The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

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"While treating glioblastoma patients with an unmethylated MGMT promoter is particularly challenging, we have been encouraged by the enhanced levels of tumor shrinkage observed to date following treatment with VAL-083 in combination with radiation," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study’s principal investigator. "Having reached this two-thirds enrollment point, we look forward to seeing further results corroborating the preliminary data we’ve received, which does appear to support the premise that VAL-083 may provide an additional and valuable treatment option for these difficult-to-treat patient conditions."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care temozolomide (TMZ) plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

"This first line study continues to enroll at a consistent pace, and we look forward to completing enrollment in this very important patient population. Once complete, we believe that the data from this study may provide additional support for the advancement of the adjuvant setting trial at MD Anderson Cancer Center, as well as to potentially support a future US study for utilization of VAL-083 as a first-line therapy for newly-diagnosed patients with an unmethylated MGMT gene promoter," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, we are very proud to be advancing all three of our Phase 2 programs for VAL-083, including the two-arm trial being conducted at MD Anderson Cancer Center in Texas for patients with recurrent GBM and those who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. We look forward to continuing to provide updates on the progress of all three patient populations."

The company recently announced the initiation of an adjuvant arm to the MD Anderson study to provide early disease data on VAL-083. This arm will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. This arm is in addition to a trial arm treating patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled, and both arms are being conducted at the University of Texas MD Anderson Cancer Center.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

On July 31, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that Kevin Hrusovsky, Chief Executive Officer, President and Chairman of Quanterix, will present at the Canaccord Genuity 39th Annual Growth Conference, on Wednesday, Aug. 7, 2019 at 9:30 a.m., EDT at the InterContinental Boston (Press release, Quanterix, JUL 31, 2019, View Source [SID1234537957]). Hrusovsky, who will also share remarks at an investor dinner the prior evening hosted by Canaccord Genuity to discuss company momentum in advancing Alzheimer’s treatments and diagnoses, will also be available for one-on-one meetings during the conference.

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"Our mission to disrupt the field of precision health has been fueled by recent product launches incorporating new technological innovations, expansion of our assay menu, greater scale and capabilities in our CLIA-certified Accelerator Service Lab, and most recently the strategic acquisition of UmanDiagnostics, which further accelerates our ability to expand the availability of Nf-L as a transformative biomarker for neurodegenerative diseases," said Hrusovsky. "These achievements demonstrate the impact of our disruptive innovation in the field of precision health, and we are excited to return to Canaccord Genuity this year to share greater insight into our growth trajectory, mission to revolutionize today’s healthcare system, and broad opportunity horizon for future value creation."

In addition to acquiring UmanDiagnostics AB and consolidating its operations in Billerica, Mass., Quanterix further solidified its position as a market leader through several recent critical milestones, including:

The expansion of Quanterix’ executive leadership team with top-tier commercial talent;
Unveiling of the Simoa HD-X Analyzer, which has already been placed with several early access customers;
Hosting of major Alzheimer’s Disease KOL dinner event at the 2019 Alzheimer’s Association International Convention;
Hrusovsky’s recognition as a 2019 Entrepreneur Of The Year in New England, one of the region’s highest business honors; and,
Completion of a nearly $50 million capital raise.
Hrusovsky will elaborate on these advances and share details regarding the Company’s unique growth strategy inside its product portfolio and commercial channel footprint.

To access the live webcast of Quanterix’ presentation, please visit the News & Events page within the investor relations section of the Quanterix website at www.quanterix.com. Replays of the webcast will be available for 90 days following the conference.