10-Q – Quarterly report [Sections 13 or 15(d)]

Bio-Path Holdings has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Bio-Path Holdings, 2017, NOV 9, 2017, View Source [SID1234521842]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

10-Q – Quarterly report [Sections 13 or 15(d)]

Sophiris Bio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Sophiris Bio, 2017, NOV 9, 2017, View Source [SID1234521888]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cyclacel Pharmaceuticals Reports Third Quarter 2017 Financial Results

On November 9, 2017 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the third quarter ended September 30, 2017 (Press release, Cyclacel, NOV 9, 2017, View Source [SID1234521859]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company’s net loss applicable to common shareholders for the three months ended September 30, 2017 was $8.9 million, which includes a $7.0 million charge in the quarter related to accounting for the Series A Convertible Preferred Stock issued in the July financing, or $0.91 per share, compared to net loss applicable to common shareholders of $3.0 million, or $0.86 per share, for the third quarter of 2016. As of September 30, 2017, cash and cash equivalents totaled $26.0 million.

"Following selection of a recommended Phase 2 dose, or RP2D, for our CYC065 CDK inhibitor, we are advancing our clinical programs, led by CYC065 in selected, patient populations relevant to the drug’s mechanism," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "In part 1 of an ongoing, Phase 1 study, CYC065 demonstrated durable target engagement and biomarker suppression at well tolerated doses in 11 out of 13 patients treated at the RP2D. Initial anticancer activity was observed in five patients, which included patients with relevant tumor molecular features. In parallel, we are progressing designs for further translational clinical studies to evaluate CYC065 in combination with venetoclax in chronic lymphocytic leukemia, or CLL; alone and with standard of care in solid tumors, in which we believe biomarker suppression may be beneficial; and in certain pediatric cancers. Data from the Phase 3 SEAMLESS study of sapacitabine have been selected for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper), or ASH (Free ASH Whitepaper), Annual Meeting in December. The presentation will include additional data emerging from a comprehensive analysis of prespecified subgroups, e.g. low peripheral white blood cell count, which will form the basis of the Company’s consultations with regulatory authorities. Following our July offering, we project cash resources to fund currently planned programs through the end of 2019."

Business Highlights

Transcriptional Regulation Program: CYC065 CDK inhibitor

Part 2 of the Phase 1 translational study will evaluate additional dosing schedules in patients with advanced solid tumors, in particular those with amplification of cyclin E, Mcl-1 or MYC, including subsets of high grade serous ovarian and uterine cancers. Biospecimens will be collected for assessment of biomarkers related to CYC065’s mechanism of action. In part 1 of an ongoing, first-in-human, single agent, ascending dose, Phase 1 study, prolonged reduction of Mcl-1 was observed in 11 out of 13 evaluable patients treated at the RP2D following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed in 5 patients, of which 4 were treated at the RP2D and 3 of which were reported by investigators to have molecular features of their cancers associated with CYC065’s mechanism of action, including overexpression or amplification of Mcl-1, MYC and/or cyclin E. The trial is being conducted at the Dana Farber Cancer Institute in Boston.
Discussions with principal investigators and/or cooperative groups are progressing with the objective of evaluating CYC065 in both pediatric and adult patients. One such study, to be conducted as an investigator sponsored trial, will evaluate the drug in patients with leukemias, including AML, and in particular those with mixed lineage leukemia rearrangements, or MLL-r. In parallel, the Company is discussing with investigators a potential evaluation of CYC065 in patients with neuroblastoma, a mostly pediatric life-threatening malignancy, frequently associated with MYC amplification.
DNA Damage Response (DDR) Program

Enrollment has been completed in an extension of the Phase 1 study evaluating the combination regimen of sapacitabine and seliciclib, our first generation CDK inhibitor, in an enriched population of approximately 20 patients with BRCA positive advanced breast cancer.
Part 3 of this study has been opened for enrolment with the objective of testing a revised dosing schedule in additional patients, including BRCA positive, ovarian and pancreatic cancer patients.
SEAMLESS Phase 3 Study

Data from the SEAMLESS study of sapacitabine in acute myeloid leukemia, or AML, have been selected for oral presentation at the 59th ASH (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia, on December 11, 2017.
The presentation will include additional data from a comprehensive analysis of the SEAMLESS dataset with the objective of characterizing the prespecified subgroups of patients, e.g. those with low peripheral white blood cell count, who appeared to have clinically relevant benefit from the investigational treatment regimen.
As previously reported, in the intent-to-treat population, the investigational arm of the SEAMLESS study did not reach statistically significant improvement in OS versus an active control. However, improvement in OS was observed in a stratified subgroup of patients with low baseline peripheral white blood cell count. The subgroup comprised approximately two-thirds of the study’s population.
Following analysis of the full SEAMLESS data set and database lock, the Company is developing submission materials to support consultations with European and US authorities with the objective of determining potential regulatory pathways.
July Underwritten Offering

On July 21, 2017, the Company announced the closing of an underwritten offering, with net proceeds of approximately $13.7 million after deducting underwriting discounts and commissions and other estimated offering expenses, including full exercise of the underwriters’ overallotment option. The Company issued and sold in the offering (i) 3,154,000 Class A Units, each consisting of one share of the Company’s common stock, and a warrant to purchase one share of common stock, and (ii) 8,872 Class B Units, each consisting of one share of the Company’s Series A Convertible Preferred Stock convertible into 500 shares of common stock at the initial conversion price, and a warrant to purchase a number of shares of common stock equal to $1,000 divided by the conversion price. The price to the public in the offering was $2.00 per Class A Unit and $1,000 per Class B Unit.
To date, holders of 8,608 (97%) shares out of the 8,872 initially issued shares of Series A Preferred Stock have elected to convert their shares into 4,304,000 shares of common stock. Following such conversions, 11,904,521 shares of common stock and 264 (3%) shares of Series A Preferred Stock remain outstanding.
Business Highlights
Anticipated Upcoming Milestones

Initiate CYC065 Phase 1b in relapsed/refractory CLL in combination with venetoclax, a Bcl-2 inhibitor
Update mature data from the part 1 extension sapacitabine/seliciclib DDR study in the BRCA +ve breast cancer cohort
Complete part 3 in the sapacitabine/seliciclib DDR study in patients with BRCA +ve cancers, including ovarian and pancreatic
Submit CYC140 (PLK1 inhibitor) IND application
Update CYC065 Phase 1 data in solid tumors
Conduct regulatory authority meetings regarding the SEAMLESS study of sapacitabine in AML
Financial Highlights

Revenues for the three months and year ended September 30, 2017 were $0.0 million compared to $0.2 million for the same period of the previous year.

As of September 30, 2017, cash and cash equivalents totaled $26.0 million, compared to $16.5 million as of December 31, 2016.

Research and development expenses were $1.0 million compared to $2.4 million for the same periods in 2016.

General and administrative expenses for the three months ended September 30, 2017 decreased to $1.2 million compared to $1.3 million for the same period in 2016.

Other expense, net for the three months ended September 30, 2017 were $0.0 million, compared to $0.1 million for the same period of the previous year. The increase in other income (expense) is primarily related to foreign exchange movements.

The UK research & tax credit for the quarter was $0.2 million.

Net loss for the three months September 30, 2017 was $1.9 million compared to $2.9 million for the same period in 2016.

At of the end of the quarter the company had cash of $26.0 million.

Conference call information (November 9, 2017 at 4:30 p.m. ET):

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 4396538

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.

Puma Biotechnology Reports Third Quarter 2017 Financial Results

On November 9, 2017 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter and nine months ended September 30, 2017 (Press release, Puma Biotechnology, NOV 9, 2017, View Source [SID1234521899]). Unless otherwise stated, all comparisons are for the third quarter and nine months of 2017 compared to the third quarter and nine months of 2016.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On July 17, 2017, Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and began shipments to wholesalers at the end of July 2017. In the third quarter of 2017, the Company reported net revenue from initial sales of NERLYNX of approximately $6.1 million.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $77.2 million, or $2.07 per share, for the third quarter of 2017, compared to a net loss applicable to common stock of $65.8 million, or $2.02 per share, for the third quarter of 2016. Net loss applicable to common stock for the first nine months of 2017 was $227.9 million, or $6.15 per share, compared to $203.4 million, or $6.26 per share, for the first nine months of 2016.

Non-GAAP adjusted net loss was $50.7 million, or $1.36 per share, for the third quarter of 2017, compared to non-GAAP adjusted net loss of $36.0 million, or $1.11 per share, for the third quarter of 2016. Non-GAAP adjusted net loss for the nine months ended September 30, 2017 was $144.7 million, or $3.90 per share, compared to non-GAAP adjusted net loss of $115.4 million, or $3.55 per share, for the nine months ended September 30, 2016. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the third quarter of 2017 was $54.9 million. Net cash used in operating activities for the nine months ended September 30, 2017 was $136.9 million. At September 30, 2017, Puma had cash and cash equivalents of $79.7 million and marketable securities of $26.6 million, compared to cash and cash equivalents of $194.5 million and marketable securities of $35.0 million at December 31, 2016.

Effective October 31, 2017, Puma entered into a credit facility with Silicon Valley Bank and Oxford Finance for a term loan of up to $100 million, subject to funding in two tranches. The Company received gross proceeds of $50 million from the first tranche of the credit facility upon closing on October 31, 2017 and intends to use the funds for general corporate purposes and to further support NERLYNX commercial initiatives. The second tranche of $50 million may be drawn at the Company’s option and is subject to the achievement of certain milestones. The loan will mature on October 31, 2022.

"With the U.S. approval and launch of NERLYNX in the third quarter, we began providing early stage HER2-positive breast cancer patients with an additional option to reduce their risk of disease recurrence," said Puma Chief Executive Officer and President Alan H. Auerbach. "We are pleased with the feedback that we have received from patients, prescribers and payors during the initial launch and we look forward to continuing to execute our commercial activities throughout 2017 and beyond.

"Looking forward, we anticipate the following milestones: (i) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2017; (ii) receiving a regulatory opinion from the Committee for Medicinal Products for Human Use (CHMP) for neratinib in extended adjuvant HER2-positive early stage breast cancer in the first quarter of 2018; and (iii) reporting Phase III trial results in third-line HER2- positive metastatic breast cancer patients in the first half of 2018."

Product Revenue

Net revenue consists of sales of NERLYNX, Puma’s first and only commercial product to date. The FDA approved NERLYNX in July 2017 and the Company commenced shipment to wholesalers in late July. For the three and nine months ended September 30, 2017, net revenue was approximately $6.1 million.

Operating Expenses

Operating expenses were $83.5 million for the third quarter of 2017, compared to $66.0 million for the third quarter of 2016. Operating expenses for the nine months ended September 30, 2017 were $234.9 million, compared to $203.7 million for the nine months ended September 30, 2016.

Cost of Sales:

Cost of sales was $1.5 million for the third quarter and nine months ended September 30, 2017. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative (SG&A) expenses were $32.5 million for the third quarter of 2017, compared to $14.0 million for the third quarter of 2016. SG&A expenses for the nine months ended September 30, 2017 were $75.8 million, compared to $37.3 million for the nine months ended September 30, 2016. The $38.5 million increase during the first nine months of 2017, compared to the first nine months of 2016, resulted primarily from increases of approximately $24.2 million for professional fees and expenses, $8.2 million in payroll and related costs, $3.2 million for stock-based compensation, $2.4 million for other expenses such as travel and related costs to support the commercial launch of NERLYNX, and $0.4 million for facility and equipment costs. These increases reflect overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $49.5 million for the third quarter of 2017, compared to $52.0 million for the third quarter of 2016. R&D expenses for the nine months ended September 30, 2017 were $157.6 million, compared to $166.4 million for the nine months ended September 30, 2016. The approximately $8.8 million decrease during the first nine months of 2017, compared to the first nine months of 2016, resulted primarily from decreases of approximately $5.0 million due to a decrease in regulatory submission activity, decreased preclinical study activities and decreased drug supply manufacturing logistics, and $8.0 million for stock-based compensation, partially offset by increases during the first nine months of 2017, compared to the first nine months of 2016, of approximately $2.2 million for internal clinical development, internal regulatory affairs and quality assurance and internal chemical manufacturing, and $2.0 million for consultants and contractors.

Conference Call

Puma Biotechnology will host a conference call to report its third quarter financial results and provide an update on the company’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, November 9, 2017. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

Jazz Pharmaceuticals Announces Participation in Three Upcoming Investor Conferences

On November 9, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentations at three upcoming investor conferences (Press release, Jazz Pharmaceuticals, NOV 9, 2017, View Source;p=RssLanding&cat=news&id=2316025 [SID1234521877]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies London Healthcare Conference in London on Thursday, November 16, 2017 at 8:40 a.m. GMT / 3:40 a.m. EST. Iain McGill, senior vice president, Jazz Pharmaceuticals Europe and rest of world, will provide an overview of the company and a business and financial update.
Piper Jaffray 29th Annual Healthcare Conference in New York, NY on Tuesday, November 28, 2017 at 8:00 a.m. EST / 1:00 p.m. GMT. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
Evercore ISI Biopharma Conference in Boston, MA on Wednesday, November 29, 2017 at 10:15 a.m. EST / 3:15 p.m. GMT. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.