On August 7, 2015 Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, reported second quarter 2015 financial results and highlighted recent corporate progress (Press release, Heron Therapeutics, AUG 7, 2015, View Source;p=RssLanding&cat=news&id=2078084 [SID:1234507112]).

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Recent Corporate Progress:

In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration (FDA).
In June and July 2015, Heron initiated two Phase 2 clinical trials of HTX-011 for the prevention of post-operative pain, one in patients undergoing bunionectomy and one in patients undergoing inguinal hernia repair.

In June 2015, Heron closed an underwritten public offering of 5,520,000 shares of common stock at a public offering price of $24.75 per share. Heron received total net proceeds from the offering of approximately $128.2 million.

In May 2015, Heron reported positive, top-line results from its recently completed Phase 3 MAGIC study for SUSTOL. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the corticosteroid dexamethasone for the prevention of delayed CINV associated with HEC regimens.

In May 2015, the FDA accepted Heron’s proposal to use the 505(b)(2) regulatory pathway for HTX-019, Heron’s proprietary intravenous formulation of the NK1 receptor antagonist aprepitant for the prevention of CINV. Utilizing the 505(b)(2) regulatory pathway to significantly reduce the costs and time required for development, Heron intends to file an NDA for HTX-019 in the second half of 2016.

"We have achieved several critical milestones since our last quarterly update, including the resubmission of the SUSTOL NDA to the FDA," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "With a pipeline of four exciting product candidates with best-in-class potential and a healthy balance sheet following our successful financing in June, we are looking forward to an eventful and productive second half of 2015."

Results of Operations

As of June 30, 2015, Heron had approximately $171.5 million in cash and cash equivalents, compared to $72.7 million as of December 31, 2014. The net increase in cash and cash equivalents was primarily due to the June 2015 public offering noted above, partially offset by net cash used in operating activities.

Heron’s net cash used for operating activities for the three and six months ended June 30, 2015 was $15.8 million and $35.5 million, respectively, compared to net cash used for operating activities of $12.5 million and $28.2 million, respectively, for the same periods in 2014. Based on current operating plans and projections, Heron believes that its current cash and working capital are sufficient to fund operations through 2016.

Heron’s net loss for the three and six months ended June 30, 2015 was $23.1 million and $43.7 million, or $0.74 per share and $1.45 per share, respectively, compared to a net loss of $19.0 million and $36.5 million, or $0.78 per share and $1.52 per share, respectively, for the same periods in 2014.

The increases in net cash used for operating activities and net loss in 2015 as compared to 2014 were primarily due to clinical and manufacturing costs related to our Phase 1 and Phase 2 clinical studies for HTX-011, as well as costs associated with the development of HTX-019.

(Filing, 10-Q, Mirati, AUG 6, 2015, View Source [SID:1234507098])

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On August 6, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), reported its results of operations and financial condition for the second quarter ended June 30, 2015 (Filing, 8-K, Provectus Pharmaceuticals, AUG 6, 2015, View Source [SID:1234507050]).

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Provectus will also hold its quarterly business update conference call at 4 p.m. (EDT) today to provide a business update on PV-10 and PH-10 to the investment community and answer questions from investors.

Those who wish to participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337, approximately 15 minutes before the call. A webcast will also be available at: www.pvct.com.
A digital replay will be available by telephone approximately two hours after the completion of the call until September 30, 2015 and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID#13614501.

Second Quarter Financial Results and Balance Sheet Highlights

The Company’s cash and cash equivalents were $23,117,144 at June 30, 2015, compared with $17,391,601 at December 31, 2014.

Therefore, the Company’s ability to continue as a going concern is reasonably assured due to its cash and cash equivalents on hand at June 30, 2015. Given the Company’s current rate of expenditures and its ability to curtail or defer certain controllable expenditures, the Company has sufficient cash on hand to last well into 2017.

Stockholders’ equity at June 30, 2015, was $30,246,789. This compares to stockholders’ equity at December 31, 2014, of $25,189,876.

For additional information regarding Provectus’ results of operations and financial condition for the second quarter ended June 30, 2015, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2015.

On August 6, 2015 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) reported financial results for the second quarter ended June 30, 2015 and provided a pipeline update (Press release, Synta Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076498 [SID:1234507077]).

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"The ganetespib development program is approaching its first key milestone, with the Phase 3 GALAXY-2 trial in non-small cell lung cancer nearing its first interim analysis, which is anticipated by year end, followed by the second interim and final analyses expected in 2016," said Chen Schor, President and Chief Executive Officer of Synta. "A positive outcome of this trial has the potential to be transformational for Synta, bringing us closer to our goal of making this novel therapeutic with a unique mechanism of action available to non-small cell lung cancer patients in need of additional treatment options. Ganetespib is also being evaluated in a series of large, randomized investigator-sponsored studies for other indications, including AML, ovarian cancer and breast cancer, and we continue to move the lead candidate from our HDC program, STA-12-8666, toward the clinic. Each of these programs continues to make important progress toward value-creating milestones, and we look forward to providing updates in the months ahead."

Second Quarter Accomplishments and Recent Updates

Pivotal, Phase 3 GALAXY-2 Clinical Trial Remains on Track for Interim Analysis of Overall Survival in 2015. The Company’s pivotal GALAXY-2 trial, a Phase 3 global, randomized, multi-center study comparing the combination of ganetespib and docetaxel to docetaxel alone for the second-line treatment of advanced non-small cell lung adenocarcinoma, remains on track to meet previously provided data readout timelines. Ganetespib, the Company’s lead program, is a novel, potent small molecule inhibitor of heat shock protein 90 (Hsp90). Based on current projections and statistical assumptions, the Company expects that the first interim overall survival (OS) analysis of GALAXY-2 will be conducted by the end of 2015, and the second interim and final OS analysis will be conducted in 2016. Assuming positive interim results from the ongoing GALAXY-2 trial of ganetespib, and pending regulatory feedback, the Company plans to seek regulatory approval of ganetespib for NSCLC in 2016.

Results from the Phase 2 GALAXY-1 trial published in Annals of Oncology. Results from the Company’s Phase 2 GALAXY-1 trial were published in the May 21, online first issue of the journal Annals of Oncology. GALAXY-1 was a global, randomized, multi-center study designed to identify the patients with advanced NSCLC most likely to benefit from second-line treatment with ganetespib in combination with docetaxel versus docetaxel alone. The results from this trial demonstrated that patients diagnosed with advanced non-small cell lung adenocarcinoma more than six months prior to study entry derived the most benefit from combination treatment, leading to the selection of this population for the ongoing Phase 3 GALAXY-2 trial.

First patient enrolled in Phase 2 Portion of GANNET53 Study of ganetespib in ovarian cancer. In June, Synta announced commencement of patient enrollment in the Phase 2 portion of the GANNET53 study, a randomized, pan-European study evaluating ganetespib in combination with paclitaxel vs. paclitaxel alone in over 200 patients with metastatic, predominantly p53 mutant, platinum-resistant ovarian cancer. Enrollment in the Phase 2 portion of GANNET53 follows the successful completion of the Phase 1 portion, the results of which were recently presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The Phase 1 data demonstrated that the combination of ganetespib 150 mg/m² with paclitaxel 80 mg/m² once weekly for 3 out of 4 weeks was generally well tolerated, with no dose limiting toxicities, and was therefore chosen for the randomized phase 2 trial. GANNET53 is sponsored by Innsbruck Medical University in Austria and funded by the European Commission.

Results from three investigator-sponsored trials of ganetespib and preclinical results of STA-12-8666 presented at ASCO (Free ASCO Whitepaper). Promising results from three studies evaluating ganetespib combination therapy in ALK-positive lung cancer, platinum-resistant ovarian cancer, and rectal cancer were presented at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting. In addition, preclinical results for the Company’s lead HDC candidate, STA-12-8666, in pediatric sarcoma were also presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting. STA-12-8666 is a conjugate of an Hsp90 inhibitor and SN-38, the active metabolite of the widely used drug irinotecan. The Company remains on track for an IND submission by the first quarter of 2016 to begin clinical studies of STA-12-8666.
Second Quarter 2015 Financial Results

There were no revenues recognized in the second quarters of 2015 and 2014.

Research and development expenses were $16.4 million for the second quarter in 2015, compared to $18.8 million for the same period in 2014. General and administrative expenses were $3.1 million for the second quarter in 2015, compared to $2.9 million for the same period in 2014.

The Company reported a net loss of $19.8 million, or $0.15 per basic and diluted share, in the second quarter of 2015, compared to a net loss of $22.3 million, or $0.24 per basic and diluted share, for the same period in 2014.

As of June 30, 2015, the Company had $98.3 million in cash, cash equivalents and marketable securities, compared to $97.7 million in cash, cash equivalents and marketable securities as of December 31, 2014.

More detailed financial information and analysis may be found in the Company’s Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (SEC) on August 6, 2015.

Guidance

The Company expects its cash, cash equivalents and marketable securities of approximately $98.3 million as of June 30, 2015 will be sufficient to fund operations at least through the first half of 2016. This estimate assumes no additional funding from new partnership agreements, equity financings or further sales under its ATM facility. The timing and nature of certain activities contemplated for the remainder of 2015 and 2016 will be conducted subject to the availability of sufficient financial resources.

(Filing, 10-Q, Curis, AUG 6, 2015, View Source [SID:1234507063])

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