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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.

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.

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.

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]).

"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.

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.

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.

Merrimack to Present Research on Multiple Programs at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On November 3, 2015 Merrimack (Nasdaq: MACK) reported that it will present research on several of its therapeutic candidates at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), November 5-9, 2015 at Hynes Convention Center in Boston (Press release, Merrimack, NOV 3, 2015, View Source [SID:1234507928]). Presentations include recent preclinical data from Merrimack’s antibody engineering technology platforms.

Data will be presented in three poster sessions:

Poster Sessions

Istiratumab (MM-141), a bispecific antibody co-targeting IGF-1R and ErbB3, potentiates the activity of immune checkpoint inhibitors (Abstract #A89)
Poster Session A
Session Title: Immune Modulators
Friday, November 6, 2015, 12:15 PM – 3:15 PM ET
Exhibit Hall C-D

MM-151 overcomes acquired resistance to cetuximab and panitumumab in colorectal cancer cells harboring EGFR extracellular domain mutations (Abstract #LB-B05)
Poster Session B
Session Title: EGFR/Her2
Saturday, November 7, 2015, 12:30 PM – 3:30 PM ET
Exhibit Hall C-D

Inhibition of ERBB3 with MM-121, IGF1-R with MM-141 or Met with MM-131 increases the activity of EGFR inhibitor MM-151 in colorectal cancer models expressing multiple resistance ligands (Abstract #LB-C25)
Poster Session C
Session Title: Drug Resistance and Modifiers
Sunday, November 8, 2015, 12:30 PM – 3:30 PM ET
Exhibit Hall C-D