On November 3, 2016 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology reported that the earnings conference call for the third quarter 2016 will not take place to allow for more time to finalize financial results (Press release, Spectrum Pharmaceuticals, NOV 3, 2016, View Source [SID1234516234]). The Company is re-examining the accounting treatment of the 2013 acquisition of the rights to CE Melphalan from Ligand Pharmaceuticals. This re-examination is not expected to impact reported revenue or cash balance for this or prior periods. The Company plans to release full financial results as soon as possible.

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Pipeline Update:

ROLONTIS (eflapegrastim), a novel long-acting GCSF: A pivotal non-inferiority Phase 3 study was initiated under a Special Protocol Assessment (SPA) from the FDA in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer. The Company is initiating an additional Phase 3 study to enroll patients primarily in Europe. The Company is actively enrolling breast cancer patients in the current trial and expects to file a BLA in 2018. The Phase 2 data demonstrated that ROLONTIS was non-inferior to pegfilgrastim at the middle dose tested, and statistically superior in terms of duration of severe neutropenia at the highest dose tested. ROLONTIS was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: Spectrum is continuing to enroll a Phase 2 breast cancer trial in the U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. In addition, multiple Phase 2 studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture.
Financial Update for Q3 2016:

Total product sales were $30.3 million in the third quarter of 2016. Product sales in the third quarter included: FUSILEV (levoleucovorin) net sales of $4.9 million, FOLOTYN (pralatrexate injection) net sales of $11.3 million, ZEVALIN (ibritumomab tiuxetan) net sales of $2.6 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.9 million, BELEODAQ (belinostat for injection) net sales of $3.6 million, and EVOMELA (melphalan) for injection net sales of $5.9 million.

The Company ended the quarter with Cash and Cash Equivalents of $171.9 million.

On November 3, 2016 Navidea Biopharmaceuticals (NYSE MKT:NAVB) reported financial results for the quarter ending September 30, 2016 (Press release, Navidea Biopharmaceuticals, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219021 [SID1234516230]). Navidea reported total revenue for the third quarter of 2016 of $8.5 million, including Lymphoseek (technetium Tc 99m tilmanocept) injection sales revenue of $6.7 million. The income from operations was $3.4 million and the net loss attributable to common stockholders was $59,000.

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"We ended the third quarter with a clear plan for Navidea’s future. With our previously announced Letter of Intent with Cardinal Health, Inc., we believe that we have successfully identified an arrangement to extinguish the CRG (Capital Royalty Partners II L.P) debt and to focus Navidea on several attractive development efforts outside of lymphatic mapping, lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancer in North America. The contemplated transaction with Cardinal Health, as well as the impending launch of Lymphoseek in Europe by our partner SpePharm AG (Norgine BV), should provide additional income for many years to come," said Dr. Michael Goldberg, Navidea President and CEO. "Our focus moving forward will be on expansion and development of Manocept-based diagnostic markets initially in rheumatoid arthritis and cardiovascular disease, as well as developing our immunotherapeutic platform with a strong preclinical pipeline for cancer, autoimmune, inflammatory and infectious diseases."

Specific events and milestones achieved since the beginning of the third quarter include the following:

Operational & Financial

Entered into Letter of Intent with Cardinal Health, Inc. for the sale of Lymphoseek in North America;
Operating activities provided cash of $1.3 million during the first nine months of 2016, compared to $14.9 million cash used in operations during the same period in 2015;
Reduced cash used in operations by over 100% for the first nine months of 2016 compared to the same period of 2015; and
Appointed Michael M. Goldberg, M.D. President and Chief Executive Officer, and Eric K. Rowinsky, M.D. Chairman of the Board.
Commercial

Achieved sequential quarter-on-quarter Lymphoseek sales revenue growth;
Earned a $500,000 milestone payment from Cardinal Health with the sale of the 100,000th Lymphoseek dose;
Received positive opinion in Europe for new Lymphoseek reduced-mass vial enabling a single injection per vial and triggering a $500,000 milestone payment by our partner, Norgine BV; and
Continued to support the projected Q4 launch of Lymphoseek in Europe by Norgine BV.
Immunodiagnostic & Immunotherapeutic Development Pipeline

Received both Institutional Review Board at University of California, San Francisco and Western Institutional Review Board approvals for a tilmanocept subcutaneous administration clinical trial protocol in rheumatoid arthritis, allowing subject enrollment to begin. To date, 17 of 18 patients have been dosed and imaged;
Received Institutional Review Board approval for a tilmanocept clinical trial protocol in Kaposi Sarcoma which is supported by an NIH grant;
Clinical trial results of tilmanocept in cardiovascular disease from Massachusetts General Hospital have been submitted for publication; and
Completed a number of additional preclinical animal studies and initiated additional studies with the MT 1000 and MT 2000 class of compounds.
Financials

"We are pleased with our financial performance despite the significant disruption in our organization caused by the ongoing litigation with CRG. Our results demonstrate our commitment to our commercial efforts and controlling our operating expenses," said Jed Latkin, interim Chief Operating Officer and Chief Financial Officer at Navidea.

Total revenues for the quarter ended September 30, 2016 were $8.5 million compared to $4.0 million in the third quarter of last year. Third quarter 2016 product revenues recognized from the sale of Lymphoseek were $6.7 million, compared to $4.2 million in the second quarter of 2016 and $3.0 million in the third quarter of 2015. During the third quarter of 2016, the Company also reported $1.8 million in licensing, grant and other revenue. For the nine months ended September 30, 2016, Navidea’s total revenue was $18.6 million compared to $9.0 million for the same period in 2015, an increase of 108%. The primary driver of this increase was revenues recognized by Navidea from the sale of Lymphoseek which exceeded $14.7 million for the nine months ended September 30, 2016 compared to $6.8 million for the same period last year. Third quarter 2016 revenue from the sale of Lymphoseek included $2.0 million of inventory purchases by Cardinal Health and $500,000 of additional revenue from a milestone related to the sale of the 100,000th Lymphoseek dose by Cardinal Health.

Third quarter 2016 margins also remained above 80%, contributing to a total gross profit of $7.6 million for the quarter, compared to $3.5 million for the same period last year. For the nine months ended September 30, 2016, total gross profit rose to $16.6 million versus $7.7 million for the same period last year, an increase of 115%. The increases in total gross profit in the third quarter and first nine months of 2016 was primarily due to $2.0 million of inventory purchases by Cardinal Health, a $500,000 milestone related to the sale of the 100,000th Lymphoseek dose by Cardinal Health, and receipt of a $500,000 milestone payment, and recognition of the remaining $500,000 of the upfront license fee received from SpePharm related to the positive regulatory opinion on a reduced-mass vial in Europe.

Research and development (R&D) expenses for the third quarter of 2016 were $1.3 million, compared to $3.9 million in the third quarter of last year. R&D expenses were $6.5 million for the nine months ended September 30, 2016 compared to $10.2 million in the same period of 2015. The net decreases in year-to-date R&D expenses were primarily a result of decreased headcount costs coupled with decreased project costs related to the Company’s neuro assets and Lymphoseek, offset by increased project costs related to the Company’s therapeutic programs. Selling, general and administrative (SG&A) expenses for the third quarter of 2016 were $2.9 million, compared to $3.9 million in the third quarter of last year. SG&A expenses were $9.9 million for the nine months ended September 30, 2016, compared to $13.5 million for the same period in 2015. The net decrease in year-to-date SG&A expenses was due primarily to decreased headcount coupled with decreased costs related to business development consulting services, contracted medical science liaisons, commercialization costs for Lymphoseek, license fees and investor relations, offset by increases in commercial and medical headcount costs related to the addition of our internal sales force and medical science liaisons coupled with increased legal and professional services. Total operating expenses were $4.2 million for the third quarter of 2016, compared to $7.8 million in the third quarter of last year. Operating expenses were $16.4 million for the nine months ended September 30, 2016, compared to $23.7 million for the same period in 2015.

Navidea’s income from operations for the quarter ended September 30, 2016 was $3.4 million compared to a loss from operations of $4.3 million for the same period in 2015. For the nine months ended September 30, 2016, Navidea’s income from operations was $210,000 compared to a loss from operations of $15.9 million for the same period in 2015. Navidea’s net loss attributable to common stockholders for the quarter ended September 30, 2016 was $59,000, or $0.00 per share, compared to net loss attributable to common stockholders of $8.1 million, or $0.05 per share, for the same period in 2015. For the nine months ended September 30, 2016, Navidea’s net loss attributable to common stockholders was $10.4 million, or $0.07 per share, compared to a net loss attributable to common stockholders of $25.1 million, or $0.17 per share, for the same period in 2015. Net losses attributable to common stockholders include fees paid to CRG (which the Company is disputing in court), the interest expense on our outstanding debt, as well as significant non-cash charges. For the nine-month periods ended September 30, 2016 and September 30, 2015, net loss attributable to common stockholders included $10.6 million and $9.1 million, respectively, in interest, debt-related fees, losses on extinguishment of debt, and changes in the fair value of financial instruments.

Navidea ended the quarter with $4.3 million in cash, $3.5 million of which was restricted related to the CRG debt.

On November 3, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that new data will be presented from multiple studies related to its lead investigational candidate, KTE-C19, at the American Society of Hematology (ASH) (Free ASH Whitepaper) 58th Annual Meeting in San Diego, CA, December 3-6, 2016 (Press release, Kite Pharma, NOV 3, 2016, View Source [SID1234516227]).

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"In the last year alone, Kite has made significant advancements in our efforts to transform the treatment of cancer and deliver the first, and potentially transformative, personalized CAR-T cell therapy," said David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. "At this year’s ASH (Free ASH Whitepaper) meeting, we will show additional detail from the interim analysis from ZUMA-1 as well as new KTE-C19 data and reproducibility in our manufacturing process from our ZUMA-3 and ZUMA-4 trials. The additional data sets continue to provide deeper insights into the therapy’s potential to transform the treatment of B-cell malignancies."

Oral Presentations

A Phase 2 Multicenter Trial of KTE-C19 (anti-CD19 CAR T Cells) in Patients with Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL): Interim Results From ZUMA-1

Abstract #998 View Source
Presenter: Sattva Swarup Neelapu, M.D., The University of Texas MD Anderson Cancer Center, Houston, TX
Monday, December 5, 2016: 3:00 p.m. PST; Room 24
This oral presentation will feature initial results from Cohort 2 of the pivotal ZUMA-1 Phase 2 trial. Cohort 2 focuses on patients with chemorefractory PMBCL and TFL, both forms of aggressive non-Hodgkin lymphoma (NHL). In September 2016, Kite announced interim positive topline results from ZUMA-1 in both Cohort 1 (chemorefractory diffuse large B-cell lymphoma (DLBCL)) and Cohort 2.

Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL)

Abstract #1227 View Source
Presenter: Marianna Sabatino, M.D., Kite Pharma, Director of Product Sciences
Monday, December 5, 2016: 6:45 p.m. PST; Room 30
This presentation will describe the robust and reliable manufacturing process utilized in the multicenter ZUMA-3 and -4 studies for the production of KTE-C19 for patients with R/R ALL.

T cells Expressing a Novel Fully-human Anti-CD19 Chimeric Antigen Receptor Induce Remissions of Advanced Lymphoma in a First-in-humans Clinical Trial

Abstract #999 View Source
Presenter: Jennifer Brudno, M.D., Clinical Fellow, National Cancer Institute (NCI)
Monday, December 5, 2016: 3:15 p.m. PST; Room 24
This presentation will review a Phase 1 dose-escalation trial conducted to investigate the safety and efficacy of engineered T cells with a fully-human anti-CD19 chimeric antigen receptor for the treatment of advanced lymphoma. This investigational therapy is being evaluated pursuant to Kite’s Cooperative Research and Development Agreement with the NCI.

Poster Presentation

High Rates of Minimal Residual Disease-Negative (MRD−) Complete Responses (CR) in Adult and Pediatric and Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials

Poster #2803 View Source
Presenter: B. Shah, M.D., Department of Hematological Malignancies, H. Lee Moffitt Cancer Center and Research Institute
Sunday, December 4, 2016: 6:00-8:00 p.m. PST; Poster II; Hall GH
This poster will review the preliminary safety and efficacy data from the Phase 1 portion of ZUMA-3 and ZUMA-4 trials of KTE-C19 in adult and pediatric patients with R/R ALL.

About KTE-C19

Kite Pharma’s lead product candidate, KTE-C19, is an investigational therapy in which a patient’s T cells are engineered to express a CAR to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. KTE-C19 has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

On November 3, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that new preclinical data on the Company’s novel IGN ADCs, IMGN632 and IMGN779, will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, which is being held December 3-6, 2016 in San Diego, CA (Press release, ImmunoGen, NOV 3, 2016, View Source [SID1234516225]).

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IMGN632, a CD123-targeting ADC and IMGN779, a CD33-targeting ADC, both use ImmunoGen’s new family of indolino-benzodiazepine cancer-killing agents called IGNs. ImmunoGen designed IGN payloads to alkylate DNA without crosslinking it. Data being presented at ASH (Free ASH Whitepaper) will demonstrate that DNA-alkylating IGNs are ultra-potent, yet provide increased tolerability compared with DNA crosslinking versions.

"Accelerating our earlier-stage portfolio with an emphasis on our IGN ADCs is one of ImmunoGen’s strategic priorities, and we believe the IMGN632 and IMGN779 preclinical data being presented at ASH (Free ASH Whitepaper) further demonstrate why we are excited about the potential of these programs," said Richard Gregory, Ph.D., executive vice president and chief scientific officer of ImmunoGen.

In an oral presentation, the Company will report preclinical data demonstrating the activity of IMGN632 in multiple acute myeloid leukemia (AML) models and patient samples at concentrations far below levels that affect normal bone marrow cells, suggesting the potential for efficacy in AML patients in the absence of or with limited myelosuppression. In a separate poster presentation, preclinical data for IMGN632 will be reported demonstrating prolonged survival in AML xenograft models. Preclinical data from a combination study of IMGN779 with a PARP inhibitor, demonstrating enhanced activity in several AML models including patient derived tumor cells and a disseminated AML xenograft model, will also be presented in an investigator poster presentation.

A Phase 1 trial of IMGN779 as monotherapy in AML is ongoing with the first clinical data expected to be reported in 2017. ImmunoGen intends to submit an IND application and initiate clinical testing of IMGN632 in 2017.

Oral Presentation
Title: "A CD123-Targeting Antibody-Drug Conjugate (ADC), IMGN632, Designed to Eradicate Acute Myeloid Leukemia (AML) Cells While Sparing Normal Bone Marrow Cells"

Oral presentation, session #616: Monday, December 5, presentation time 11:45am PT. Abstract #768.
Poster Presentations
Title: "IMGN632: A CD123-Targeting Antibody-Drug Conjugate (ADC) with a Novel DNA-Alkylating Payload, Is Highly Active and Prolongs Survival in Acute Myeloid Leukemia (AML) Xenograft Models"

Poster session #616: Sunday, December 4, 6:00-8:00pm PT. Abstract #2832.
Title: "Combining IMGN779, a Novel Anti-CD33 Antibody-Drug Conjugate (ADC), with the PARP Inhibitor, Olaparib, Results in Enhanced Anti-Tumor Activity in Preclinical Acute Myeloid Leukemia (AML) Models"

Poster session #616: Saturday, December 3, 5:30-7:30pm PT. Abstract #1645.
Data will also be presented on agents which use ImmunoGen’s maytansinoid ADC technology, including IMGN529 and Biotest’s indatuximab ravtansine (BT062).

Additional information, including abstracts, can be found at www.hematology.org.

On November 3, 2016 GTx, Inc. (Nasdaq: GTXI) reported financial results for the third quarter ended September 30, 2016 and provided an update on the Company’s clinical development activities (Press release, GTx, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219024 [SID1234516223]). The Company has three ongoing Phase 2 clinical trials: two trials evaluating enobosarm as a potential treatment for women with advanced androgen receptor positive breast cancer and another trial assessing enobosarm as a potential treatment for stress urinary incontinence in postmenopausal women.

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"We made excellent progress during the quarter, including demonstrating clinical benefit in Stage 1 of the 9 mg dose group which enabled us to advance this dose group to the second and final stage of the ER+/AR+ breast cancer trial," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "In addition we are pleased with the continued financial support of key existing investors who participated in our equity offering last month which enables us to continue to pursue key milestones in the coming months for our breast cancer and stress urinary incontinence programs, as well as our SARD technology."

Corporate Highlights and Anticipated Milestones

Enobosarm in Breast Cancer: The Company’s lead product candidate, a selective androgen receptor modulator (SARM), is being developed as a targeted treatment for two advanced breast cancer indications: (i) estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer, and (ii) AR+ triple negative breast cancer (TNBC). For both clinical trials, the primary efficacy endpoint is a determination of clinical benefit (CB), which is defined as a complete response, partial response or stable disease.

ER+/AR+ breast cancer: The Company has an ongoing Phase 2 clinical trial of enobosarm (GTx-024) in women with advanced, ER+/ AR+ breast cancer. Patients receive orally-administered enobosarm (9 mg or 18 mg) daily for up to 24 months. The first stage of evaluation will be assessed among the first 18 evaluable patients for each cohort. If at least 3 of 18 patients per cohort achieve CB at week 24, the trial will proceed to the second stage of enrollment. The primary efficacy objective of the trial is clinical benefit response following 24 weeks of treatment, which, under the clinical trial protocol, will be demonstrated if at least 9 of 44 evaluable patients achieve CB. Those patients demonstrating CB at week 24 will continue to receive treatment for up to 24 months. The two dose cohorts in the trial will be treated independently for the purpose of assessing efficacy.

The Company announced in September 2016 that the 9 mg dose group demonstrated clinical benefit in Stage 1 of the trial allowing the 9 mg cohort to advance to Stage 2;
The Company expects to announce top-line results from Stage 1 of the 9 mg cohort before the end of 2016.
AR+ TNBC: The Company has an ongoing open-label, multi-center, multinational Phase 2 clinical trial to evaluate the efficacy and safety of orally administered enobosarm in up to 55 women with advanced, AR+ TNBC. Patients will receive 18 mg of enobosarm once daily for up to 12 months. Stage 1 of the trial will be assessed among the first 21 evaluable patients. If at least 2 of 21 patients achieve clinical benefit at week 16, then the trial will proceed to Stage 2 of enrollment of up to a total of 41 evaluable patients. The primary efficacy objective of the trial is clinical benefit response following 16 weeks of treatment in 41 evaluable patients.

The Company expects to have sufficient data from Stage 1 of the trial in the first quarter of 2017 to determine if patient enrollment should continue into Stage 2 of the trial.
SARMs in Non-Oncologic Indications: The Company is exploring SARMs as potential treatments for both stress urinary incontinence (SUI) and Duchenne muscular dystrophy (DMD), a rare disease characterized by progressive muscle degeneration and weakness.

Stress Urinary Incontinence: Enrollment in the Phase 2 proof-of-concept clinical trial of 3 mg of enobosarm in women with SUI is ongoing. This is the first clinical trial to evaluate a SARM for SUI. The Company believes that developing an oral therapy to treat the growing number of women who suffer a diminished quality of life from stress urinary incontinence presents a unique commercial opportunity, especially since current therapies may sometimes involve invasive procedures. The Company expects to have data from the trial during the first half of 2017.

Duchenne muscular dystrophy: Preclinical studies have confirmed the beneficial effects from SARMs in mice genetically altered to simulate DMD, compared to control groups. The Company continues to pursue a potential strategic collaboration with biopharma companies experienced in orphan drug development.

SARDs in Prostate Cancer: Our Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer (CRPC), including those who do not respond or are resistant to currently approved therapies. The Company believes that its SARD compounds will degrade multiple forms of the androgen receptor, including AR splice variants, such as AR-V7, along with mutant versions of the receptor.

Castration-Resistant Prostate Cancer: Lead SARD compounds are undergoing further preclinical development, including formulation and pharmacokinetic studies. The Company plans to initiate its first human clinical trial with a SARD in 2017.

Third Quarter and Nine Months 2016 Financial Results

In October 2016, the Company completed a registered direct offering of its common stock resulting in net proceeds of approximately $13.6 million. Under the terms of the offering, the Company sold 17.3 million shares of its common stock at a purchase price of $0.81 per share, which was the consolidated closing bid price of the Company’s common stock on October 11, 2016. The investors in the offering consisted of certain existing shareholders of the Company, including J.R. Hyde, III, its largest shareholder and Lead Director of the Company’s Board of Directors (the "Board"), Robert J. Wills, the Board’s Executive Chairman, and Marc S. Hanover, the Company’s Chief Executive Officer and a member of the Board.
As of September 30, 2016, cash and short-term investments were $13.4 million, which does not include the proceeds noted above from our recent equity financing, compared to $29.3 million at December 31, 2015.
Research and development expenses for the quarter ended September 30, 2016 were $4.6 million compared to $3.8 million for the same period of 2015.
General and administrative expenses were $2.3 million for the quarter ended September 30, 2016 compared to $2.0 million for the same period of 2015.
The net loss for the quarter ended September 30, 2016 was $6.9 million compared to net income of $34.9 million for the same period in 2015. Net income for the quarter ended September 30, 2015 included a non-cash gain of $40.7 million due to the change in the fair value of the Company’s warrant liability. During the first quarter of 2016, the Company recorded a non-cash reclassification of this warrant liability to stockholders’ equity due to modification of these warrants. No adjustments to the fair value of these warrants are required subsequent to the first quarter of 2016.
The net loss for the nine months ended September 30, 2016 was $10.9 million compared to a net loss of $15.5 million for the same period of 2015. The nine months ended September 30, 2016 included a non-cash gain of $8.2 million due to the change in the fair value of the Company’s warrant liability, recorded during the first quarter of 2016. The nine months ended September 30, 2015 included a non-cash gain of $352,000 due to the change in fair value of the Company’s warrant liability.
GTx had approximately 141.9 million shares of common stock outstanding as of September 30, 2016. Additionally, there remain warrants outstanding to purchase approximately 64.3 million shares of GTx common stock at an exercise price of $0.85 per share.