Oncolytics Biotech® Demonstrates Positive Data in Two Posters
at AACR Annual Meeting 2018

On April 18, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported two posters highlighting data from pelareorep studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018. The conference takes place April 14-18, 2018, in Chicago (Press release, Oncolytics Biotech, 18 18, 2018, View Source [SID1234525555]).

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"These posters add additional confirmation of pelareorep’s promotion of an inflammatory signature in different cell lines," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The study by doctor Wilkinson demonstrates that pelareorep can establish an inflamed tumor phenotype and the presentation by doctor Goel highlights the synergistic combination of pelareorep and an anti-PD1 agent. Taken together, these findings highlight that pelareorep is priming the immune system and enhancing the activity of checkpoint blockade. As MSS CRC typically does not respond to checkpoint blockade, viral priming could expand the use of this drug class by making non-susceptible tissue susceptible by turning cold tumors hot. This work will of course lead to additional studies in combination with other immunotherapies."

Presenter: Sanjay Goel, MD, Associate Professor of Medicine, Montefiore Medical Center
Presentation Title: Potentiating effect of reovirus in anti-PD1 therapy in colorectal cancer
Session Title: Receptor Targeting and the Tumor Microenvironment
Location: Poster Section 38
Poster Board #: 17
Poster Number: 3917

Data presented in the poster demonstrated:

pelareorep administration increased PD-L1 expression on MSS CRC cells;

possible evidence of a vaccine effect: immunologically competent mice were re-challenged with the original tumor and the tumor was unable to propagate;

combination therapy made statistically significant improvements in survival compared to controls in both BALB/c (median 42 vs. 16 days, p=0.003) and C57BL/6 (median 24 vs. 17 days, p=0.02) mice; and

pelareorep treated xenografted tumor tissue showed a higher infiltration of T lymphocytes as confirmed by CD8-positive and intensified granzyme staining.

Presenter: Grey Wilkinson, PhD, Translational Scientist, Oncolytics Biotech
Presentation Title:
Pelareorep promotes the expression of a chemokine signature that predicts response to immunotherapy
Session Title: Immunomodulatory Agents and Interventions 2
Location: Poster Section 33
Poster Board #: 10
Poster Number: 4707

Data presented in the poster demonstrated:

the expression of a chemokine signature that predicts response to immunotherapy;

global changes in gene expression are unique and different for each cell line following pelareorep infection and changes in gene expression occur before significant cell lysis;

pelareorep differentially promotes the expression of innate and adaptive immunity related genes in HCC, CRC, NSCLC cell lines; and

pelareorep promotes the expression of gene signatures that predict response to immuno-therapies in HCC cells.

These posters are now available on the Posters & Publications page of the company’s website: www.oncolyticsbiotech.com/technology/posters-publications.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

Some Fun Facts about AACR 2018

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1Q2018 Earnings Call Highlights Abbott’s $7.4 Billion In Sales

On April 18, 2018 Abbott reported financial results for the first quarter ending March 31, 2018. Key takeaways from this morning’s earnings call include (Press release, BioSpace, APR 18, 2018, View Source [SID1234525502]):

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First-quarter reported sales growth of 16.7 percent
First-quarter organic sales growth of 6.9 percent
First-quarter adjusted earnings per share from continuing operations of 59 cents, at the upper end of the previous guidance range
Several recently launched products contributing to strong growth
"We’re off to a strong start to the year as we forecasted," said Miles D. White, chairman and chief executive officer. "We’re particularly pleased with the continued strong growth in medical devices and improving performance in our nutrition business."

The company’s adjusted income rose to 59 cents per share on $7.39 billion in sales for its first quarter, beating Zacks Investment Research estimates of 58 cents on $7.26 billion in sales. Last year at this time, Abbott shares were trading at 48 cents with $6.34 billion in sales.

An infographic from the company highlights an increase of 6.9 percent in worldwide organic sales led by successes in nutrition, diagnostics, established pharmaceuticals and medical devices.

"Back in January I commented that we were entering the year with strong momentum which has continued as we forecasted," White added during the earnings call. "The strong growth we are achieving is a direct result of the steps we have taken to position the company in the most attractive areas of health care as well as the outstanding productivity of our new product pipeline."

Despite the company’s upbeat attitude about its Q1 earnings, shares dipped 3.5 percent early Wednesday on pharmaceutical sales that lagged behind Wall Street’s expectations by nearly 4 percent.

Revenue from established pharmaceuticals fell short by $56 million, RBC Capital Markets wrote in a note to clients. Also, Evercore noted the $1.04 billion in sales for that unit missed the consensus by 3.6 percent.

Medical device sales had the best organic growth in Q1, rising 9.4 percent to $2.74 billion. That beat the consensus for $2.67 billion, Evercore noted. Diagnostics also performed well, rising 5.5 percent organically to $1.84 billion in sales to top the consensus by $69 million.

"For the full year 2018, we continue to forecast organic sales growth of 6 percent to 7 percent," said Chief Financial Officer Brian Yoor. "In addition, we continue to expect rapid diagnostics to contribute sales of a little more than $2 billion."

With a forecasted adjusted gross margin ratio of around 59 percent of sales, Yoor said that research and development investments will be adjusted to around 7.5 percent of sales, and selling, general and administrative expenses adjusted above 30.5 percent of sales."

Worldwide, nutrition sales were $1.76 billion, up 4.7 percent organically and topping guidance for low single-digit growth. Both adult and pediatric segments performed well, growing a respective 4.3 percent and 5.1 percent on an organic basis.

But, White cautioned, nutrition is a highly competitive business in a branded space. "I give our U.S. team a lot of credit for how well they’ve done in the pediatric and adult (nutrition) space. It’s extremely competitive and it’s competitive in both pediatric and adult. And we will see from time-to-time a competitor tries false advertising or other things to take momentary share. But I think overall, we’ve not only sustained our position, but steadily grown it, from a share standpoint."

For the year, Abbott reaffirmed its adjusted profit target of $2.80 to $2.90 a share. Analysts modeled adjusted earnings of $2.87 per share and $30.91 billion in sales. Abbott also sees second-quarter adjusted income coming in at 70 to 72 cents per share.

Rgenix Presents Pre-Clinical Data on RGX-202 at the 2018 AACR Annual Meeting

On April 18, 2018 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that it is presenting pre-clinical data from ongoing research of RGX-202, a small molecule compound in development designed to inhibit SLC6a8, a creatine transporter, integral to cancer cell energy metabolism (Press release, Rgenix, APR 18, 2018, View Source [SID1234525519]). In a poster presentation today at the 2018 American Association of Cancer Research Annual Meeting, "RGX-202, a first-in-class small-molecule inhibitor of the creatine transporter SLC6a8, is a robust suppressor of cancer growth and metastatic progression", the data showed RGX-202 to be a robust inhibitor of creatine uptake in cancer cells and to be active in several pre-clinical gastrointestinal cancer models both as a single agent and in combination with chemotherapy.

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RGX-202 is a small molecule that inhibits a novel cancer metabolism target, SLC6a8, which is involved in supplying energy to cancer cells. SLC6a8 is over-expressed in several prevalent cancer types, including gastrointestinal malignancies such as colorectal cancer.

More than 140,000 patients are diagnosed with colorectal cancer annually in the U.S. With approximately 50,000 deaths in the U.S. attributed to the condition annually, it is a leading cause of cancer deaths. Creatine metabolism has been shown to spur the growth of colon cancer. This pathway is activated by colon cancer cells to allow uptake of phosphorylated creatine that can be converted to ATP to fuel survival of cancer cells as they proliferate and spread. RGX-202 inhibits this pathway by blocking the ability of SLC6a8 to import phosphocreatine into cancer cells.

In the pre-clinical research presented today, the impact of RGX-202 was studied alone, and in combination with standard of care chemotherapy agents such as 5-FU.

On its own, RGX-202 induced cancer cell death in vivo and demonstrated anti-tumor activity in both KRAS mutant and KRAS wild-type models of gastrointestinal cancer. RGX-202 also suppressed colon cancer and pancreatic cancer liver metastatic colonization, a model of metastatic cancer progression. Importantly, RGX-202 significantly extended survival of tumor-bearing mice as a single agent.

Studies combining RGX-202 with 5-FU resulted in additive anti-tumor activity, with complete tumor regressions among 50% of treated mice and significantly prolonged survival versus 5-FU treatment alone.

Masoud Tavazoie, MD, PhD, and Chief Executive Officer of Rgenix, said, "The data presented today is just a snapshot of our pre-clinical progress on our research of RGX-202. These data show the strong potential for RGX-202 and support further research of the compound. With these data, we are building a strong foundation for future clinical development of RGX-202, which, with regulatory approval, would diversify our clinical pipeline."

MorphoSys Announces Pricing of Initial Public Offering of American Depositary Shares (ADSs) on Nasdaq

On APril 18, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the pricing of its initial public offering (IPO) in the United States. The offering produced gross proceeds of USD 207,832,000 from the sale of 2,075,000 new ordinary shares in the form of 8,300,000 American Depositary Shares ("ADSs") at a price of USD 25.04 per ADS. Each ADS will represent 1/4 of a MorphoSys ordinary share (Press release, MorphoSys, APR 18, 2018, View Source [SID1234525575]).

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Furthermore, MorphoSys has granted the underwriters an option to purchase up to 1,245,000 additional ADSs, representing 15% of the total number of ADSs placed in the offering. This option can be exercised during the 30-day period commencing April 18, 2018.

The new ordinary shares underlying the ADSs and, if the option will be exercised, the additional ADSs will be issued from MorphoSys’s authorized capital 2017-II, excluding pre-emptive rights of existing shareholders and representing up to 8.1% (including the underwriters’ option to purchase additional ADSs) of the registered share capital of MorphoSys prior to the consummation of the offering.

MorphoSys’s ordinary shares are listed on the Frankfurt Stock Exchange under the symbol "MOR".

The ADSs are expected to begin trading on the Nasdaq Global Market on April 19, 2018, under the symbol "MOR".

The closing of the offering is expected to occur on April 23, 2018, subject to customary closing conditions.

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Leerink Partners LLC, are acting as lead book-running managers, and Berenberg Capital Markets, LLC and JMP Securities LLC are acting as co-managers for the ADS offering.

A Registration Statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission on April 18, 2018.

Within the United States of America, the securities referred to in this release are offered only by means of a prospectus. A copy of the prospectus can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mailing [email protected].