On August 13, 2019 Medtronic plc (NYSE:MDT) reported that it will report financial results for the first quarter of fiscal year 2020 on Tuesday, August 20, 2019 (Press release, Medtronic, AUG 13, 2019, View Source;p=RssLanding&cat=news&id=2406530 [SID1234538640]). A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source The news release will include summary financial information for the company’s first quarter of fiscal year 2020, which ended on Friday, July 26, 2019.

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Medtronic will host a webcast at 7:00 a.m. CDT to discuss financial results for its first quarter of fiscal year 2020. The webcast can be accessed at View Source on August 20, 2019.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal year 2020 second, third quarter, and fourth quarter results on Tuesday, November 19, 2019, Tuesday, February 18, 2020, and Thursday, May 21, 2020, respectively. Confirmation and additional details will be provided closer to the specific event.

On August 13, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the commencement of a registered underwritten public offering of $200.0 million in shares of its common stock (Press release, Deciphera Pharmaceuticals, AUG 13, 2019, View Source [SID1234538656]). In addition, Deciphera intends to grant the underwriters a 30-day option to purchase up to $30.0 million in shares of its common stock.

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J.P. Morgan, Piper Jaffray and Jefferies are acting as joint book-running managers for the offering.

Deciphera intends to use the net proceeds of the offering to fund: clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trials, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; Investigational New Drug-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; and working capital purposes, including general operating expenses.

A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) and was declared effective by the SEC on October 12, 2018. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does 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 August 13, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that it has been awarded three distinct patents in the U.S., Canada, and Europe: U.S. Patent No. 10,369,568 entitled CELL SEPARATION USING MICROCHANNEL HAVING PATTERNED POSTS; Canadian Patent No. 2,756,493 entitled DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS; and European Patent No. 2,619,588 entitled METHODS AND REAGENTS FOR SIGNAL AMPLIFICATION (Press release, Biocept, AUG 13, 2019, View Source [SID1234538705]).

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The U.S. issued patent broadly covers methods and apparatus used for the capture of target biomolecules, including cells of interest, using microchannels that disrupt flow to aid capture. The Canadian patent covers the capture of target cells, including CTCs, using a combination of binding partners and methods for capture on any surface. The European patent encompasses methods for enhancing the detection of cells using fluorescent complexes. The combination of these patents significantly expands the breadth of intellectual property protection for Biocept’s technologies in terms of their applications and global reach. These three new patents expand Biocept’s intellectual property estate to 36 issued patents globally.

"Collectively, the granting of these additional patents further broadens Biocept’s U.S. and international footprint for capturing and analyzing any biological target of interest," said Lyle Arnold, Ph.D., Chief Scientific Officer at Biocept. "For Biocept’s core business, this includes CTCs from any sample type, however these patents also expand the use of Biocept’s technologies well beyond its current core business and may provide opportunities to out-license our technologies for a variety of uses."

"Increasing shareholder value by broadening U.S. and international patent protection used in our Target Selector liquid biopsy platform is a key strategic initiative, as we seek to develop our business globally, with the potential to license our technologies for uses outside the scope of our core business," said Michael Nall, Biocept President and CEO. "We now have been granted 36 issued patents covering our tests and technologies, and plan to continue to strengthen our intellectual property position with additional patent issuances to come."

On August 13, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter ended June 30, 2019 (Press release, Oncolytics Biotech, AUG 13, 2019, View Source [SID1234538729]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Oncolytics remains focused on advancing our highly differentiated, systemically delivered oncolytic virus platform, which has generated multiple big pharma partnership opportunities on the back of an established clinical proof-of-concept, as the only viral agent to show a survival benefit in late-stage metastatic breast cancer," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "This quarter we secured a landmark co-development agreement with Pfizer and Merck KGaA to run BRACELET-1 in order to confirm our positive randomized phase two results in metastatic breast cancer and investigate if the addition of their checkpoint inhibitor Bavencio can add to the doubling of overall survival benefit we’ve seen with the virus. We believe this latest and most committed collaboration to date represents pharma’s growing interest in exploring the ability of our first-in-class, systemically delivered oncolytic virus to augment the effects of a range of immune checkpoint inhibitors. It also demonstrates the growing interest in our biomarker development, which we initially presented at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April, where we presented evidence of a biomarker that has the potential to predict which patients are likely to respond to pelareorep even before we begin treatment, and to confirm the response as quickly as three weeks posttreatment. The clinical development impact of this can be significant, as the biomarker will allow us to better select patients for our clinical trials and to stratify the treatment populations within each protocol based on the biomarker outcome. This would result in more cost-efficient and faster-enrolling trials, with a greater likelihood of success. We also experienced a positive impact on business development, including our co-development agreement with Pfizer and Merck KGaA, as well as additional growing interest from pharma and big biotech. While we intend to expand into additional, commercially valuable indications, including other co-therapies with the checkpoint inhibitor class of drugs, we’ve continued to advance our lead clinical program in breast cancer. We remain on track to report interim safety and primary endpoint biomarker data from the AWARE-1 study in the fourth quarter of 2019 and initiate BRACELET-1 in the first quarter of 2020."

Select highlights since April 1, 2019

Clinical & Scientific Updates

Announced phase 2 study (BRACELET-1) to investigate pelareorep in combination with paclitaxel and anti-PD-L1 antibody avelumab in hormone-receptor positive, human epidermal growth factor 2-negative (HR+ / HER2-) metastatic breast cancer in collaboration with Pfizer and Merck KGaA
Initiated and announced preliminary safety run-in data from the AWARE-1 window of opportunity study, which is being conducted in collaboration with SOLTI, in which patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep with or without Roche’s anti PD-L1 Tecentriq, followed by surgery
Announced the identification of a biomarker and initial data at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper), demonstrating that patients treated with pelareorep in combination with chemotherapy and pembrolizumab showed changes in their T cell repertories with high turnover and significant expansion, including new T cell clones, during treatment
Highlighted additional immune biomarker analyses during the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating that pelareorep-induced T cell expansion and upregulation of pro-inflammatory genes was durable and correlated with patient survival
Hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD
Financial

At June 30, 2019, the company reported $12.3 million in cash and cash equivalents
As at August 2, 2019, the company had an unlimited number of authorized common shares with 20,390,316 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,580,611 options and share units
Operating expense for the second quarter of 2019 was $1.8 million compared to $1.6 million in the second quarter 2018
Research and development expense for the second quarter of 2019 was $3.5 million compared to $2.0 million in the second quarter 2018
The net loss for the second quarter of 2019 was $5.3 million compared to $4.2 million in the second quarter 2018, which equates to a loss of $0.26 per share in 2019 compared to a net loss of $0.27 per share in 2018, on a consolidated basis
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On August 13, 2019 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the second quarter 2019 (Press release, Cyclacel, AUG 13, 2019, View Source [SID1234538641]). The Company’s net loss applicable to common shareholders for the three months ended June 30, 2019 was $1.8 million. As of June 30, 2019 cash and cash equivalents totaled $15.2 million.

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"We are excited to report new evidence of anticancer activity for CYC065. In part 2 of our Phase 1 study of CYC065 as a single agent, a patient with endometrial cancer with MCL1 amplification treated on the fourth dose level achieved tumor shrinkage. This patient was previously treated with liposomal doxorubicin, carboplatin, and multiple investigational therapies," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Following our recent announcement of the first patient dosed in a Phase 1/2 study with an oral combination of sapacitabine and venetoclax in relapsed or refractory AML or MDS, we are now dosing patients in five clinical studies in pursuit of our strategy of overcoming cancer resistance mechanisms through combinations of our candidates with approved drugs. The first two patients in the relapsed or refractory CLL study evaluating the combination of CYC065 and venetoclax remain on treatment for 4 and 6 cycles respectively. A total of 4 patients with BRCA mutant breast cancer have been treated in the Phase 1/2 investigator sponsored trial (IST) evaluating sapacitabine and olaparib and one patient has achieved partial response (PR). With projected cash to the end of 2020 we look forward to delivering on multiple data outcomes from our ongoing studies."

Key Company Highlights

·Reported first evidence of anticancer activity in part 2 of the Phase 1 study (065-01) as a single agent testing a frequent dosing schedule of four, one-hour infusions every three weeks in which a patient with endometrial cancer with MCL1 amplification treated on the fourth dose level of 213mg achieved tumor shrinkage;
·Reported that patients with relapsed/refractory CLL treated in the 065-02 study with CYC065 plus venetoclax are continuing treatment after ibrutinib front-line failure;
Announced treatment of the first patient in a Phase 1 study (065-03) evaluating the safety and effectiveness of CYC065, a CDK2/9 inhibitor shown to durably suppress MCL1, in combination with venetoclax, a BCL2 inhibitor, in patients with relapsed or refractory AML or MDS. Preclinical data confirmed synergy of CYC065 and venetoclax, suggesting that the suppression of both BCL2 and MCL1 may be more beneficial than inhibiting either one alone;
·Announced treatment of the first patient in part 2 of a Phase 1/2 study (682-11) evaluating the safety and effectiveness of an oral regimen of sapacitabine in combination with venetoclax in patients with relapsed or refractory AML or MDS. Sapacitabine is a nucleoside analogue that is active in AML and MDS relapsed or refractory to prior therapy such as cytarabine or hypomethylating agents. Combining sapacitabine with venetoclax may offer an effective, oral treatment regimen for patients who have failed front-line therapy;
·Following an amendment of the Phase 1 study (065-01) of single agent CYC065 in patients with advanced cancers part 3 of the study will evaluate an oral form of CYC065.

þ 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466

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www.cyclacel.com – [email protected]

Key Upcoming Business Objectives

·Report initial data from the CYC065-venetoclax Phase 1 studies in relapsed/refractory leukemias;
·Report initial data from the sapacitabine-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
·Report initial data from the CYC140 Phase 1 First-in-Human study;
·Report initial data and bioavailability from the Phase 1 study of an oral formulation of CYC065;
·Report updated CYC065 Phase 1 data with frequent dosing schedule in patients with advanced solid cancers;
·Report data from the IST Phase 1b/2 trial of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators;
·Determine regulatory pathway and submissibility of sapacitabine in elderly AML patients.

Financial Highlights

As of June 30, 2019, cash and cash equivalents totaled $15.2 million compared to $17.5 million as of December 31, 2018. The decrease of $2.3 million was primarily due to net cash used in operating activities of $6.3 million, offset by net proceeds from a Common Stock Sales Agreement with H.C. Wainwright of $4.1m.

Research and development expenses were $1.2 million for the three months ended June 30, 2019 compared to $1.2 million for the same period in 2018.

General and administrative expenses were $1.2 million for the three months ended June 30, 2019 compared to $1.3 million for the same period in 2018.

Other income, net for the three months ended June 30, 2019 was $0.2 million compared to $0.1 million for the same period of the previous year.

The United Kingdom R&D tax credit was $0.3 million for the three months ended June 30, 2019 compared to $0.5 million for the same period in 2018.

Net loss for the three months ended June 30, 2019 was $1.8 million compared to $1.9 million for the same period in 2018. With the projected cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $15.2 million as of June 30, 2019, will be sufficient to finance operations through the end of 2020.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 7654539

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.