On November 9, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that it will host a live conference call and webcast at 4:30 p.m. ET on Tuesday, November 14, 2017 to report its third quarter 2017 financial results and provide a corporate update (Press release, Eleven Biotherapeutics, NOV 9, 2017, View Source [SID1234521862]).

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To access the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) at least five minutes prior to the start time and refer to conference ID 3890769. An audio webcast of the call will also be available on the Investors & Media section of the Company’s website, www.elevenbio.com. An archived webcast will be available on the Company’s website approximately two hours after the event and will be available for 30 days.

On November 9, 2017, Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that Stephen Hurly, President and Chief Executive Officer, will present a company overview at the Stifel 2017 Healthcare Conference in New York on Wednesday, November 15, 2017 at 3:30 p.m. EST (Press release, Eleven Biotherapeutics, NOV 9, 2017, View Source [SID1234521861])Eleven Biotherapeutics, Inc. (NASDAQ:EBIO).

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A live webcast can be accessed from the Investors & Media section of Eleven’s website, www.elevenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.

On November 9, 2017 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended September 30, 2017, and provided an overview of recent accomplishments and plans (Press release, CytRx, NOV 9, 2017, View Source [SID1234521860]).

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"The third quarter of 2017 was transformative for CytRx," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "We executed a global strategic licensing transaction for aldoxorubicin, placing this clinically validated, post-Phase 3 asset into the hands of NantCell, Inc. to file the planned New Drug Application with the U.S. FDA. Further, NantCell is laying the groundwork to develop aldoxorubicin in combination with other anti-cancer agents, including immunotherapies and other innovative cell-based approaches, and recently communicated their plans to submit Investigational New Drug (IND) Applications to the U.S. FDA combining aldoxorubicin with certain immunotherapy protocols in patients with pancreatic and breast cancer."

Mr. Kriegsman continued, "Internally, our efforts and resources have been refocused on generating new candidates from our proprietary LADR (Linker Activated Drug Release) technology platform where our goal is to create a new class of rationally designed, breakthrough anti-cancer drugs with the potential to address a broad range of tumor types. Selection of a highly potent drug conjugate to bring into the clinic is at the forefront of our strategy heading into 2018, and we remain opportunistic in seeking out strategic alliances with big pharma."

Third Quarter 2017 and Recent Highlights

Highlighted Progress of LADR Candidates and Future Oncology Pipeline. In November 2017, CytRx provided an update on its R&D activities surrounding its proprietary LADR (Linker Activated Drug Release) Technology Platform. To date in 2017, the Company’s drug discovery laboratory, located in Freiburg, Germany, has tested over 75 rationally designed drug conjugates, and four lead candidates have been selected based on in vitro and animal preclinical studies, stability, and manufacturing feasibility. The Company’s goal is to nominate the next LADR candidate for clinical development in the first quarter of 2018 and to present these important preclinical data at an upcoming scientific meeting during the first half of 2018. Additional animal efficacy and toxicology testing of these lead candidates is underway, and CytRx’s goal is to file the first LADR-discovered, ultra-high potency conjugate IND for clinical trials in 2018.

Completed Reverse Stock Split. On November 1, 2017, CytRx completed a 1-for-6 reverse stock split of its issued and outstanding common stock. The split-adjusted shares of CytRx’s common stock will continue trading on the Nasdaq Capital Market under the Company’s existing symbol "CYTR," provided that the Company continues to comply with the Nasdaq listing requirements. The reverse stock split reduced the number of common shares outstanding to approximately 27.6 million as of the effective date. Authorized shares were also proportionally reduced to approximately 41.7 million, and the Company’s preferred stock was reduced to approximately 0.8 million shares. The reverse stock split was approved by the Company’s stockholders at a Special Meeting held on October 27, 2017.

Completed Strategic Realignment of Clinical Development Team. In November 2017, the Company announced a strategic realignment of its development team to focus its efforts on generating new drug candidates from its LADR Technology Platform. Hurley Consulting Associates, who have been providing strategic consulting to CytRx, will lead the company’s development and regulatory activities. Concurrently, the position of Senior Vice President of Drug Development has been eliminated, and Shanta Chawla, M.D., has retired.

Announced Upcoming NantCell INDs. In October 2017, CytRx announced that aldoxorubicin licensee NantCell, Inc. (a private subsidiary of NantWorks, LLC) plans to submit IND applications combining aldoxorubicin with its immunotherapy protocols for clinical trials in pancreatic and breast cancers. The planned clinical trials will enroll patients with cancers resistant to standard therapy and will employ adaptive designs allowing for expansion of treatment cohorts and modification of patient treatments based on tumor profiling and individual patient responses over time.

Completed Strategic Licensing Transaction with NantCell for Development of Aldoxorubicin. In July 2017, CytRx and NantCell executed a strategic licensing agreement for the global rights to aldoxorubicin. NantCell, led by Dr. Patrick Soon-Shiong, who developed and commercialized Abraxane, an albumin-mediated cytotoxic agent, received exclusive rights to develop and commercialize aldoxorubicin for all indications. Under the terms of the agreement, NantCell purchased $13 million of CytRx common stock at a per share price of $6.60 (split-adjusted), representing approximately a 92% premium to the market price at the time of the transaction. CytRx is eligible to receive up to an additional $343 million in regulatory and commercial milestones, plus increasing double-digit royalties on sales for aldoxorubicin’s lead indication of soft tissue sarcomas, and mid to high single-digit royalties for any additional indications. CytRx also issued NantCell a warrant to purchase on a split-adjusted basis up to 500,000 shares of common stock at $6.60 over the next 18 months. CytRx has been actively working with the NantCell team to transition the aldoxorubicin program, including both completed and ongoing studies.

Third Quarter 2017 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $46.0 million as of September 30, 2017. During the third quarter, CytRx entered into a global strategic licensing agreement for aldoxorubicin with NantCell and received a strategic investment of $13.0 million. Concurrent with the closing of the aldoxorubicin license agreement, CytRx amended its existing long-term loan and made payments of $10 million during the quarter to the lender.

Net loss for the quarter ended September 30, 2017, was $5.1 million, or $(0.19) per share, compared with a net loss of $12.2 million, or $(0.80) per share, for the quarter ended September 30, 2016, a reduction of $7.1 million. During the third quarter of 2017, the Company recognized a non-cash gain of $3.8 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash gain of $0.2 million during the third quarter of 2016 related to now expired warrants.

Research and development (R&D) expenses were $4.8 million for the third quarter of 2017, including approximately $2.6 million for aldoxorubicin, $1.0 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (Freiburg lab), and approximately $1.2 million for non-cash expenses and general operations of our clinical programs. This is a reduction of approximately 47 percent compared to R&D expenses of $8.9 million for the third quarter of 2016.

General and administrative (G&A) expenses were $3.4 million for the third quarter of 2017, compared with $2.8 million for the third quarter of 2016.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical company specializing in research and clinical development of novel anti-cancer drug candidates that employ linker technologies to enhance the accumulation and release of drug at the tumor. Aldoxorubicin, CytRx’s most advanced drug conjugate, is an improved version of the widely used chemotherapeutic agent doxorubicin and has been out-licensed to NantCell, Inc. CytRx is also rapidly expanding its pipeline of ultra-high potency oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx’s expertise in albumin biology and linker technology for the development of a new class of potential breakthrough anti-cancer therapies.

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]).

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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.

On November 9, 2017 Caladrius Biosciences, Inc. (NASDAQ: CLBS) ("Caladrius" or the "Company"), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, reported results for the three and nine months ended September 30, 2017 (Press release, Caladrius Biosciences, NOV 9, 2017, View Source [SID1234521858]).

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Highlights of the 2017 third quarter and recent weeks include:

•
Enrolled the 70th subject in The Sanford Project: T-Rex Study (the "T-Rex Study"), a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for recent-onset type 1 diabetes ("T1D"), which triggered a $2.4 million milestone payment and the delivery of 508,475 shares of Caladrius common stock as per the terms of the September 2016 private placements;
•
Reached 50% of subjects, or 56 patients, treated in the T-Rex Study, which establishes a timeframe for a prescribed interim analysis when the first 56 patients reach their 6-month follow-up visit; and
•
Awarded approximately $2 million as a Small Business Innovative Research ("SBIR") grant from the National Heart, Lung and Blood Institute of the National Institutes of Health ("NIH") to support a Phase 2 clinical study with CLBS14 in patients with coronary microvascular dysfunction ("CMD").

Management Commentary

"Throughout the third quarter and following the sale of our contract manufacturing business to Hitachi Chemical, we made significant progress advancing Caladrius as a purely development-focused biopharmaceutical company and achieved key milestones in a number of our clinical development programs," stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. "Our lead program, the T-Rex study, remains on track to complete enrollment by the end of this year. Additionally, we expect to have the results of a planned pre-specified interim analysis of the data from the six-month follow-up of the first 56 patients around the end of the first quarter of 2018."

"Furthermore, we continue to execute according to our strategy to advance our pipeline programs with collaborative support, such as grants, partnerships or licensing. During the third quarter 2017, we were pleased to receive an NIH grant to help fund our Phase 2 study of CLBS14 in CMD. We also continue to receive funding from the California Institute for Regenerative Medicine ("CIRM") grant in support of the T-Rex study," Dr. Mazzo continued. "The successful sale of our PCT manufacturing subsidiary earlier this year has resulted in Caladrius being well-funded and focused on advancing our clinical development programs, while also allowing us to opportunistically explore compelling therapeutic prospects through a comprehensive, disciplined and data-driven process. We look forward to achieving a number of value-creating milestones during the remainder of the year and into 2018."

Third Quarter Financial Highlights

Note: Effective with the sale of PCT to Hitachi in the second quarter of 2017, all PCT-related activities and gain on sale results will be reported as discontinued operations. All remaining operations will be reported as continuing operations. In addition, all prior year comparative financial results will restate PCT operations as discontinued operations.

Research and development (R&D) expenses for the third quarter of 2017 of $3.2 million increased 8% compared with $3.0 million in the third quarter of 2016, as the Company focuses its R&D efforts on the ongoing Phase 2 T-Rex Study and preparations for other pipeline programs. Caladrius’ clinical development programs are supported, in part, by grants and collaborations.

General and administrative (G&A) expenses for the third quarter of 2017 remained flat at $2.9 million, compared with $2.8 million in the third quarter of 2016.

The net loss from continuing operations for the third quarter of 2017 was $3.5 million, compared with the net loss from continuing operations of $6.1 million for the comparable 2016 period. The continuing operations net loss includes a tax benefit of $2.4 million, which partially offsets the tax expense reported in discontinued operations.

Loss from discontinued operations during the third quarter of 2016 was $1.2 million. Discontinued operations relate to our sale of PCT to Hitachi in the second quarter of 2017.

Net loss per share from continuing operations attributable to Caladrius common stockholders for the third quarter of 2017 was $0.38 per share compared to net loss per share of $0.95 for the same period in 2016.

Nine-Month Financial Highlights

R&D expenses for the first nine months of 2017 decreased 17% to $11.2 million compared with $13.5 million for the same period in 2016. G&A expenses were $9.1 million for the first nine months of 2017 compared with $10.5 million for first nine months of 2016. The first nine months of 2017 included $1.7 million of equity compensation expense. This unusually high expense was due to the acceleration of employee equity stock and option award vesting triggered by the sale of the Company’s PCT subsidiary to Hitachi.

The net loss from continuing operations for the nine months ended September 30, 2017 was $12.2 million, compared with the net loss from continuing operations of $25.6 million for the same period of 2016. The continuing operations net loss includes a tax benefit of $8.3 million, which partially offsets the tax expense reported in discontinued operations.

Income from discontinued operations during the first nine months of 2017 was $37.3 million, which includes a $40.2 million gain on the sale of PCT (net of $11.6 million taxes), compared with a loss from discontinued operations of $1.6 million in the same period in 2016.

Net loss per share from continuing operations attributable to Caladrius common stockholders for the nine months ended September 30, 2017 was $1.37 per share compared to net loss per share of $4.23 for the same period in 2016.

Balance Sheet Highlights

As of September 30, 2017, Caladrius had cash, cash equivalents and marketable securities of $59.4 million compared with $7.1 million as of December 31, 2016. During the third quarter of 2017, the Company received an additional $4.4 million as a final net cash settlement of the PCT transaction, bringing the total received to $79.4 million. Also during the third quarter of 2017, upon the enrollment of the 70th patient in the T-Rex study, the Company received $2.4 million and delivered 508,475 shares of Caladrius common stock as per the terms of the September 2016 private placements.

Based on existing programs and projections, the Company expects to have more than $50 million in cash and marketable securities at year-end 2017. Caladrius also expects less than $5 million of CLBS03 external spending obligations after 2017 to reach the completion of the T-Rex study, excluding any further CIRM funding. The Company is confident its cash balances and additional grant funding, along with continued disciplined expense management, will allow it to fund its current business plan beyond 2018.

Conference Call

Caladrius’ management will host a conference call for the investment community beginning today at 4:30 p.m. Eastern Time to review financial results, provide a Company update and answer questions.

Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 6198497. The call will also be broadcast live on the Company’s website at www.caladrius.com/events.

The webcast will be archived on the Company’s website for 90 days.