CytRx Reports 2015 Third Quarter Financial Results

On November 3, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended September 30, 2015, and also provided an overview of recent accomplishments and upcoming milestones (Press release, CytRx, NOV 3, 2015, View Source;p=RssLanding&cat=news&id=2105852 [SID:1234507903]).

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"Enrollment in our pivotal global Phase 3 clinical trial of aldoxorubicin in soft tissue sarcoma (STS) continues to progress quite favorably, and is on track to be completed next quarter as planned, with data expected in the second half of 2016," said Steven A. Kriegsman, Chairman and CEO of CytRx. "The third quarter saw the publication in the prestigious peer-reviewed journal JAMA Oncology of our positive global Phase 2b clinical trial results with aldoxorubicin in first line STS, and poster presentations regarding aldoxorubicin in Kaposi’s sarcoma and small cell lung cancer. Together, these results and presentations continue to strengthen the case for aldoxrobucin’s potential to become an important new treatment available for oncologists and their patients."

Third Quarter 2015 and Recent Highlights

Announced the Publication of Phase 2b Clinical Trial Results for Soft Tissue Sarcoma in the Peer-Reviewed Journal JAMA Oncology. In September 2015, JAMA Oncology, the prestigious peer-reviewed Journal of the American Medical Association (JAMA), published a paper entitled "First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial." This paper discusses the design, methodology and results from CytRx’s completed multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in patients with metastatic or locally advanced unresectable STS. The results suggest that aldoxorubicin is the first single-agent therapy to show significantly superior efficacy over doxorubicin. Additionally, patients treated with aldoxorubicin did not exhibit evidence of acute cardiotoxicity. The full article can be accessed here.

Presented Posters on Aldoxorubicin for Kaposi’s Sarcoma (KS) and Small Cell Lung Cancer (SCLC). In July 2015, interim data on from the Phase 2 clinical trial of aldoxorubicin as a treatment for Kaposi’s sarcoma were presented at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents. Aldoxorubicin treatment resulted in tumor shrinkage and reductions of KS viral load. Importantly, tumor biopsies demonstrated that aldoxorubicin was present in the KS tumors. In September 2015, at the 16th World Congress on Lung Cancer in Denver, Colorado, CytRx presented the design for the ongoing comparative global Phase 2b trial in patients with metastatic SCLC who have either relapsed or were refractory to prior chemotherapy. The global Phase 2b trial is currently enrolling 132 patients at 37 sites in the USA, Hungary and Spain.

Upcoming Presentation of Additional Results from the Phase 1b/2 Clinical Trial Combining Aldoxorubicin with Ifosfamide/Mesna. At the 20th Annual Connective Tissue Oncology Society (CTOS) Annual Meeting in Salt Lake City, Utah, on November 4-7, CytRx will present the trial design and current results of its combination dose escalation trial in patients with metastatic soft and non-soft tissue sarcomas. To date, 7 subjects received 170 mg/m2 aldoxorubicin, and 3 subjects received 250 mg/m2 aldoxorubicin (125 or 185 mg/m2 doxorubicin equivalents), administered intravenously every 4 weeks. All patients also received 1 gram/m2/day ifosfamide/mesna administered as a continuous infusion for up to 14 days, every 4 weeks. As of September 30, 2015, 8 subjects demonstrated tumor shrinkage, with 3 subjects having documented partial responses. Six subjects are still receiving treatment. Grade 3 or 4 adverse events included neutropenia (90%), anemia (70%), nausea or vomiting (10%) and febrile neutropenia (10%). No subject exhibited cardiotoxicity by echocardiogram.

Expansion of Phase 1b Clinical Trial Combining Aldoxorubicin with Gemcitabine. CytRx recently added two additional treatment cohorts as part of the ongoing trial evaluating aldoxorubicin and gemcitabine in patients with metastatic solid tumors. This trial aims to find the optimal doses of each drug when given together, and to preliminarily evaluate the efficacy of the combination therapy. Nineteen patients have been randomized to date and results are expected in 2016.

Upcoming Milestones

Complete enrollment in the first quarter of 2016 in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS under a Special Protocol Assessment, or SPA, granted by the FDA, with PFS data announced in the second half of 2016
Report updated results on the ongoing Phase 2 clinical trial of aldoxorubicin in patients with unresectable glioblastoma multiforme this quarter
Complete enrollment in the aldoxorubicin global Phase 2b trial in second-line SCLC in the second quarter of 2016, with results in the second half of 2016

Announce a new oncology pipeline drug candidate utilizing CytRx’s novel LADR technology this quarter

Third Quarter 2015 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $70.8 million as of September 30, 2015.

Net loss for the three months ended September 30, 2015 was $7.1 million, or $0.11 per share, compared with a net loss of $5.6 million, or $0.10 per share, for the three months ended September 30, 2014. The increase of $1.5 million in net loss during the current three-month period resulted primarily from a reduction in the gain on warrant derivative liability, which was $3.5 million in the current quarter, as compared to $7.3 million in the comparative 2014 period, for a difference of $3.8 million.

Research and development (R&D) expenses were $8.5 million for the third quarter of 2015, and included development expenses of $6.8 million for aldoxorubicin and $0.4 million for CytRx’s German laboratory operations. The remaining $1.3 million of R&D expenses were primarily related to research and development support costs, including non-cash employee stock option expenses.. R&D costs were $10.6 million for the third quarter of 2014.

General and administrative (G&A) expenses were $2.2 million for the third quarter of 2015, compared with $2.4 million for the second quarter of 2014. G&A expenses for the third quarter of 2015 included non-cash employee stock-compensation expense of $0.5 million, compared to $0.4 million for the same period in 2014.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Small Cell Lung Cancer

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood:brain barrier.

About Kaposi’s Sarcoma

Kaposi sarcoma is a cancer that causes lesions (abnormal tissue) to grow in the skin; the mucous membranes lining the mouth, nose, and throat; lymph nodes; or other organs. The lesions are usually purple and are made of cancer cells, new blood vessels, red blood cells, and white blood cells. Kaposi sarcoma is different from other cancers in that lesions may begin in more than one place in the body at the same time. KS remains the most common HIV-associated tumor worldwide. The condition is also endemic in certain parts of Central Africa and Central and Eastern Europe.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

MorphoSys AG Reports Results for the First Nine Months of 2015

On November 4, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported its financial results for the nine months ending September 30, 2015 (Press release, MorphoSys, NOV 3, 2015, View Source [SID:1234507929]). Group revenues were EUR 93.9 million (9-months 2014: EUR 46.9 million). Earnings before interest and taxes (EBIT) amounted to EUR 34.7 million (9-months 2014: EUR -3.7 million). The increase in revenues and EBIT is caused by the full realization of deferred revenues from an up-front payment received from Celgene in 2013 together with a one-time termination payment that the Company received with the ending of the MOR202 collaboration. On September 30, 2015, MorphoSys held cash and cash equivalents, marketable securities, and financial assets classified as loans and receivables of EUR 317.7 million in comparison to EUR 352.8 million on December 31, 2014.

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Highlights of the Third Quarter 2015

In September, MorphoSys published an updated overview of its proprietary drug pipeline and reaffirmed its plans to increase investment in development with MOR208 set to become the first proprietary drug candidate in a phase 3 study, which is aimed to start in 2017.

At the 15th International Myeloma Workshop in September, MorphoSys published an update on the safety and preliminary efficacy data of MOR202 from an ongoing phase 1/2a study. The clinical data confirmed a very good overall safety profile and promising efficacy data from the highest monotherapy cohort and the first combo-therapy cohorts.

In August, MorphoSys and G7 Therapeutics AG announced a new collaboration to support MorphoSys’s activities in developing novel antibody therapeutics targeting G protein-coupled receptors (GPCRs) and other potentially disease-related transmembrane proteins such as ion channels.

Also in August, MorphoSys announced a strategic alliance with Immatics Biotechnologies GmbH. This alliance was formed for the development of novel antibody-based therapeutics against tumor-associated peptides derived from intracellular proteins.
In July, MorphoSys announced that its partner, Heptares Therapeutics, exercised an option to initiate its own therapeutic antibody program under the research alliance entered into by the companies in February 2013.

After the end of the quarter, MorphoSys announced that it had reached a clinical milestone associated with the IND filing of an antibody being developed in the field of bleeding disorders by its partner Bayer HealthCare.

MorphoSys’s product pipeline comprised a total of 104 therapeutic antibodies, including 25 clinical programs. Three partnered programs are currently in phase 3 trials.

"Our lead product candidate MOR208 has demonstrated impressive single-agent activity in NHL and CLL, and we are on track to initiate additional trials shortly. We are also working towards taking MOR208 into a pivotal study in DLBCL which could potentially support a registration pathway," stated Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "During the quarter, we added two more collaborations to our network of relationships, thereby opening up new product opportunities."

"MorphoSys is progressing well in 2015," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "Our financial strength, together with a promising pipeline of proprietary drug candidates, allows us to scale our investment in R&D to ensure that we capture the full value of our portfolio."

Financial Review for the First Nine Months of 2015 (IFRS)

Group revenues for the first nine months of 2015 amounted to EUR 93.9 million (9-months 2014: EUR 46.9 million). Reasons for the increase were one-time effects in connection with the full realization of deferred revenues from an up-front payment received from Celgene in 2013 together with a one-time termination fee. The Proprietary Development segment recorded revenues of EUR 59.9 million (9-months 2014: EUR 11.5 million), originating mainly as a result of the termination of the co-development activities with Celgene. Revenues in the Partnered Discovery segment comprised EUR 31.5 million in funded research and licensing fees (9-months 2014: EUR 33.1 million) and EUR 2.5 million in success-based payments (9-months 2014: EUR 2.4 million).

Total operating expenses for the first nine months of 2015 amounted to EUR 63.6 million (9-months 2014: EUR 51.1 million). Total research and development expenses were EUR 53.1 million (9-months 2014: EUR 40.8 million). R&D expenses mainly consisted of costs for external lab services and personnel costs. Expenses for proprietary product and technology development amounted to EUR 39.9 million (9-months 2014: EUR 26.1 million). General and administrative expenses increased slightly to EUR 10.6 million (9-months 2014: EUR 10.3 million) driven by higher expenses for personnel.

Earnings before interest and taxes (EBIT) amounted to EUR 34.7 million (9-months 2014: EUR -3.7 million). The Proprietary Development segment reported a segment EBIT of EUR 26.5 million (9-months 2014: EUR -12.7 million), while Partnered Discovery showed a segment EBIT of EUR 18.1 million (9-months 2014: EUR 18.3 million).

For the first three quarters of 2015, MorphoSys realized a net profit of EUR 28.2 million compared to EUR -2.0 million in the same period of the previous year. The resulting diluted earnings per share for the nine months ending September 30, 2015 amounted to EUR 1.07 (9-months 2014: EUR -0.08).

On September 30, 2015, the Company held liquid funds and marketable securities, as well as other financial assets (reported in the balance sheet under cash and cash equivalents, available for sale financial assets, bonds available for sale and financial assets classified as loans and receivables), in the amount of EUR 317.7 million, compared to EUR 352.8 million on December 31, 2014. The net cash outflow from operations in the first nine months of 2015 was EUR 3.8 million (9-months 2014: net cash outflow of EUR 3.3 million). The number of shares issued at September 30, 2015 was 26,479,334, compared to 26,456,834 on December 31, 2014.

Third Quarter of 2015 (IFRS)

In the third quarter of 2015, the Company generated revenues in the amount of EUR 11.3 million, compared to EUR 16.4 million in the same quarter of 2014. Total operating expenses amounted to EUR 22.7 million in Q3 2015, compared to EUR 21.0 million in the same quarter of 2014. EBIT amounted to EUR -11.3 million (Q3 2014: EUR -4.2 million). Net loss for the third quarter 2015 was EUR 8.3 million, compared to a net loss of EUR 2.6 million in the third quarter of 2014.

Outlook for 2015

MorphoSys re-confirmed its guidance for 2015. MorphoSys anticipates total Group revenues of EUR 101 million to EUR 106 million and anticipates a positive EBIT in the range of EUR 9 million to EUR 16 million in 2015. Expenses for proprietary product and technology development are expected to amount to EUR 56 million to EUR 63 million.

Myriad Genetics Reports Fiscal First-Quarter 2016 Financial Results

On November 3, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal first-quarter 2016, provided an update on recent business highlights, maintained its fiscal year 2016 financial guidance and provided fiscal second-quarter 2016 financial guidance (Press release, Myriad Genetics, NOV 3, 2015, View Source [SID:1234507930]).

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"We were very pleased with our results in the first quarter and reiterate our fiscal 2016 guidance," said Mark C. Capone, president and chief executive officer of Myriad. "More importantly, we continued the excellent progress on our five-year plan to transform Myriad into a diversified global pioneer in personalized medicine. We are now beginning to see the benefits of the substantial investments the Company has made in our industry-leading pipeline and international expansion, which we believe will drive significant shareholder value over the next five years."

Financial Highlights

The Company exited the quarter with approximately 80 percent of incoming hereditary cancer tests being ordered as myRisk, representing 100 percent conversion of our targeted physician base.

The increase in adjusted operating income and net income on a year-over-year basis was driven by higher revenue, improved operational efficiencies in our myRisk Hereditary Cancer laboratory, lower research and development expense and leverage in sales, general and administrative expenses.

During the quarter, the Company repurchased approximately 1.1 million shares, or $38 million, of common stock under our share repurchase program and ended the quarter with approximately $117 million remaining on our current share repurchase authorization. Fiscal first-quarter diluted weighted average shares outstanding were 72.1 million compared to 76.1 million in the same period last year.

Business Highlights

At the upcoming American College of Rheumatology annual meeting Myriad will present several studies showing the potential for Vectra DA to predict treatment response in patients with rheumatoid arthritis. The studies demonstrated that the Vectra DA score was predictive of response to either triple therapy or anti-TNF therapy, predicted flare in patients discontinuing anti-TNF therapy and could predict relapse in patients undergoing tapering for disease modifying anti-rheumatic drugs.

In August, Myriad received a favorable final local coverage determination for its Prolaris test from Noridian, the Medicare Administrative Contractor for the Company. The coverage determination, which became effective October 15, 2015, covers Prolaris for patients defined as low or very-low risk by the National Comprehensive Cancer Network guidelines.

Tufts Health Plan and Myriad signed a three-year contract that will cover Prolaris for all members diagnosed with localized prostate cancer across all risk categories.

Myriad presented data at the recent American Society for Dermatopathology Annual Meeting that demonstrated the ability of myPath Melanoma to accurately predict cancer outcomes by evaluating 127 patients with melanocytic lesions. Of the 65 lesions that were classified as melanomas by pathologists, myPath Melanoma results agreed with 61 of these classifications representing a sensitivity of 97 percent. Importantly, myPath Melanoma identified 100 percent of the 14 lesions which went on to become metastatic melanoma.

At the International Association for the Study of Lung Cancer, Myriad presented data that compared the myPlan Lung Cancer score to standard pathological risk factors. Of the 183 patients that were designated as high-risk by the myPlan Lung Cancer test, less than 50 percent had three or more high-risk features and would have been designated as low-risk utilizing standard pathology.
At the European Society for Clinical Oncology Meeting, Myriad presented new data on its myChoice HRD test from the NOVA study currently being conducted by TESARO, one of Myriad’s pharmaceutical collaborators. The data showed that 100 percent of patients with a BRCA mutation and 55 percent of patients without a BRCA mutation were HRD positive and would have been missed with tumor sequencing alone. Additionally, the myChoice HRD algorithm which utilizes three proprietary technologies (LOH, TAI, and LST) better defined the HRD positive population than LOH alone.

OncoSec Announces $7.5 Million Registered Direct Offering

On November 3, 2015 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that it has entered into definitive agreements with institutional investors to purchase approximately $7.5 million of securities in a registered direct offering (Press release, OncoSec Medical, NOV 3, 2015, View Source [SID:1234507932]). OncoSec has agreed to sell to such investors an aggregate of 2,142,860 shares of its common stock at a price of $3.50 per share. Additionally, investors will receive warrants to purchase up to an aggregate of 1,071,430 shares of common stock at an exercise price of $4.50 per share for a term of 5.5 years. The warrants will become exercisable after a six-month waiting period.

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The gross proceeds of the offering are approximately $7.5 million. Net proceeds, after deducting the placement agent’s fee and other estimated offering expenses payable by OncoSec, are expected to be approximately $6.9 million. OncoSec intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.

H.C. Wainwright & Co., LLC acted as the exclusive placement agent for the transaction. Maxim Group LLC and Noble Life Science Partners acted as financial advisors to OncoSec in connection with the transaction. The offering is expected to close on or before November 6, 2015, subject to the satisfaction of customary closing conditions.

The securities described above are being offered by OncoSec pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission, or the SEC. A prospectus supplement related to the offering will be filed with the SEC. The securities may only be offered by means of a prospectus. Copies of the prospectus and prospectus supplement can be obtained directly from OncoSec and at the SEC’s website at www.sec.gov or by request from H.C. Wainwright & Co., LLC by e-mailing [email protected].

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of OncoSec’s common stock or warrants. No offer, solicitation, or sale will be made in any jurisdiction in which such offer, solicitation, or sale is unlawful.

Rigel Announces Third Quarter 2015 Financial Results

On November 3, 2015 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported financial results for the third quarter and nine months ended September 30, 2015 (Press release, Rigel, NOV 3, 2015, View Source;p=RssLanding&cat=news&id=2106100 [SID:1234507934]).

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"We are concentrating our efforts on the timely completion of our two Phase 3 studies with fostamatinib in immune thrombocytopenic purpura (ITP). We expect topline data from the first Phase 3 trial in the middle of 2016 with the second reporting shortly thereafter," said Raul Rodriguez, president and chief executive officer of Rigel. "Also, our new partnership with Aclaris Therapeutics demonstrates our continuing efforts to explore additional partnerships and advance opportunities in areas beyond our therapeutic focus." he added.

For the third quarter of 2015, Rigel reported a net loss of $6.7 million, or $0.08 per share, compared to a net loss of $20.9 million, or $0.24 per share, for the same period of 2014. Weighted average shares outstanding for the third quarters of 2015 and 2014 were 88.5 million and 87.8 million, respectively.

Contract revenues from collaborations of $13.0 million in the third quarter of 2015 were comprised of an $8.0 million upfront payment from Aclaris Therapeutics International Limited pursuant to the license agreement executed in August 2015 for the development and commercialization of certain Rigel JAK inhibitors for the treatment of alopecia areata and other dermatological conditions, as well as $4.8 million from the amortization of the $30.0 million upfront payment from Bristol-Myers Squibb. There were no contract revenues from collaborations in the third quarter of 2014.

Rigel reported costs and expenses of $19.8 million in the third quarter of 2015, compared to $21.0 million for the same period in 2014. The decrease in operating expenses was primarily due to the decrease in facilities costs resulting from the sublease agreement executed in December 2014, partially offset by the increase in research and development costs related to Rigel’s Phase 3 clinical program for fostamatinib in ITP.

For the nine months ended September 30, 2015, Rigel reported a net loss of $38.8 million, or $0.44 per basic and diluted share, compared to a net loss of $68.6 million, or $0.78 per basic and diluted share, for the same period of 2014.

As of September 30, 2015, Rigel had cash, cash equivalents and short-term investments of $134.4 million, compared to $143.2 million as of December 31, 2014. Rigel expects to end 2015 with cash and investments in excess of $115.0 million, which is expected to be sufficient to fund operations into the second quarter of 2017.