On July 31, 2019 GEMoaB GmbH, a biopharmaceutical company focused on the development of next generation immunotherapies for hard-to-treat cancers, reported the dosing of the first patient in a Phase I open-label, dose escalation study of GEM3PSCA, an Affinity-Tailored Adapter for T-Cells (ATAC) (Press release, GEMoaB Monoclonals, JUL 31, 2019, View Source [SID1234537972]). The bispecific antibody binds to the CD3-Receptor on T-cells and prostate stem cell antigen (PSCA), differentially and broadly expressed in a variety of late stage solid tumors, such as castrate-resistant prostate cancer, pancreatic and breast cancer, bladder and renal cancer as well as non-small cell lung cancer. The ongoing execution of its clinical development plan reflects GEMoaB’s strategy to position itself as a leading and fully integrated biotech company for long-term success, building on the strong science and R&D foundation of the company.

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"In addition to moving forward with multiple pre-clinical assets of our earlier-stage portfolio this year, we are pleased to demonstrate the productivity of our proprietary next generation ATAC platform by advancing GEM3PSCA, our second internally discovered molecule, into the clinic. GEM3PSCA follows our ongoing Phase I study of our first ATAC asset GEM333 in CD33-positive relapsed/refractory AML," said Armin Ehninger, Ph.D., Chief Scientific Officer of GEMoaB. "Due to its unique molecular features, GEM3PSCA has the potential to balance efficacy and tolerability and benefit the large number of patients whose metastatic cancer is expressing PSCA. We look forward to conducting the early clinical work for GEM3PSCA in close cooperation with highly experienced academic clinical centers and are proud about our global GEM333 and GEM3PSCA partnerships with Celgene."

Purpose of the Phase I study is to evaluate safety, pharmacokinetics, pharmacodynamics and clinical activity of GEM3PSCA in patients with advanced solid tumors expressing PSCA. GEM3PSCA will be administered as a single agent dosed as a continuous infusion over 7-day cycles. Cohorts of patients will receive ascending doses of GEM3PSCA to determine the maximum tolerated dose (MTD) or optimal dose. Patients must have evidence of expression of the PSCA antigen from their tumor tissue, measured by immunohistochemistry, in order to be eligible for the study.

"We are excited to participate in the development of this novel approach to the immunologic treatment of solid tumors," said Prof. Dr. Ralf Bargou, Head of Comprehensive Cancer Center Mainfranken at the University Hospital Würzburg. "PSCA is a very promising target expressed in multiple late stage cancers that do not sufficiently benefit from currently existing targeted or immunotherapies. We are very motivated to provide our broad expertise in early clinical trial conduct and immuno-oncology and work closely with the GEMoaB team in order to rapidly obtain meaningful safety and efficacy results for GEM3PSCA."

About the Affinity-Tailored Adaptor for T-Cells (ATAC) platform
GEMoaB’s platform of Affinity-Tailored Adaptors for T-Cells (ATAC) is characterized by high binding affinity to tumor antigens and lower affinity to the CD3 antigen on T-effector cells, preventing T-cell auto-activation in pre-clinical models. Safety and tolerability of the treatment are also increased by the relatively short (60 min) serum half-life. The use of fully humanized antibodies reduces the potential risk of immunogenicity even in case of chronic dosing. The first two clinical stage ATAC assets are GEM333 and GEM3PSCA. GEM333 is an ATAC with binding specificities to CD3 and CD33, currently in early clinical development in CD33 positive relapsed/refractory acute myeloid leukemia (for further information see View Source). GEM3PSCA is an ATAC with binding specificities to CD3 and PSCA, currently in early clinical development in multiple PSCA positive advanced solid tumors (for further information see View Source). GEM333 and GEM3PSCA are globally partnered with Celgene.

On July 31, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported that it will release its financial and operating results for the second quarter ended June 30, 2019, on Wednesday, August 14, 2019, after the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, JUL 31, 2019, View Source [SID1234538996]). The Company will host a conference call on Wednesday, August 14, 2019, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.

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The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13692586. To access the live webcast, go to the investor relations section on the Company’s website, View Source

On July 31, 2019 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the potential of the microbiome organ to treat disease and improve human health, reported that management will participate in a fireside chat at the 39th Annual Canaccord Genuity Growth Conference in Boston, MA on Thursday, August 8, 2019 at 1:00 p.m. ET (Press release, Kaleido Biosciences, JUL 31, 2019, View Source [SID1234540066]).

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A live audio webcast will be available through the Investors & Media section of Kaleido’s website at View Source An archived replay will be accessible for 90 days following the event.

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.