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Sunday, July 7, 2019

Celyad to Review Clinical Update from ESMO 21st World GI Congress

Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced that Professor Dr. Eric Van Cutsem from Universitair Ziekenhuis Leuven (UZ Leuven) will present data from the NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, at the upcoming European Society for Medical Oncology (ESMO) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain. Following the oral and poster presentations at WCGIC, Celyad’s management team will host a conference call to discuss the initial clinical results from the SHRINK and alloSHRINK trials.
Filippo Petti, CEO of Celyad noted “We are honored to have Professor Dr. Van Cutsem present preliminary data from our SHRINK and alloSHRINK trials, including an initial glimpse of data from the industry’s first off-the-shelf investigational non-gene edited CAR-T candidate, CYAD-101. The comparable trial designs investigating similar NKG2D-based CAR-T therapies should provide for a unique comparison of an autologous and allogeneic engineered cell therapy approach for the treatment of metastatic colorectal cancer.”
Poster Oral Presentation
Title: Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer
Abstract: SO-009
Presenter: Eric Van Cutsem, M.D., Universitair Ziekenhuis Leuven (UZ Leuven)
Date: Friday, July 5, 9:00 a.m. CEST
Location: Auditorium B, Level 0
The poster (same title, same number) will be presented in the Exhibit Hall, Level 0 on Friday, July 5, 2019 from 10:35am – 11:05am CEST and 04:35pm – 05:05pm CEST.
Conference Call / Webcast Details
A conference call including a Q&A session will be held by the Company on Friday July 5, 2019 at 2:00 pm CEST / 8:00 am EDT.
The conference call can be accessed using the details below:
United States:     +1 877 407 9208
International:      +1 201 493 6784
Conference ID:   13692101
Alternatively, participants may also access an audio webcast of the event using the link below:  http://public.viavid.com/index.php?id=135092
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Saturday, July 6, 2019

Bayer Seeks to Reassure Investors on Roundup Settlement Talks

Bayer AG Chief Executive Officer Werner Baumann sought to reassure German investors about the prospects of settling litigation over the company’s Roundup weedkiller, an effort to regain their confidence after an unprecedented rebuke at the company’s shareholder meeting in April.
The embattled CEO held a series of meetings in Frankfurt this week with key shareholders, according to people familiar with the situation. The outreach comes as the company battles thousands of lawsuits from people who say the weedkiller caused their cancer. Bloomberg Intelligence analysts have said the cases could result in a settlement of as much as $10 billion.
Baumann told investors that Ken Feinberg, the high-profile mediator appointed to lead settlement talks for some of the cases, met with both parties and wouldn’t have agreed to take the job if he didn’t think he could broker a deal, according to one of the people, who asked not to be named because the investor discussions were private.
Bayer is trying to win over shareholders concerned that it mishandled the fallout over Roundup after acquiring the herbicide last year in the $63 billion purchase of Monsanto Co. The German company rejects claims that the weedkiller causes cancer and has vowed to keep fighting after losing three trials since the Monsanto deal closed last summer.
The meetings came at an auspicious time. A federal judge said he’ll probably reduce — but not throw out entirely — an $80 million jury verdict against Bayer in the second case to go to trial over claims that Roundup causes cancer.

Damage Award

U.S. District Judge Vince Chhabria said at a hearing Tuesday in San Francisco that part of the damages awarded to a California man for his pain and suffering may have been miscalculated and that the $75 million portion of the verdict intended to punish the company may be too high.
Bayer is working to rehabilitate its image as it battles mounting suspicion over the safety of Roundup’s active ingredient, glyphosate. Austria’s parliament earlier this week voted to ban herbicides containing glyphosate, a first in the European Union.
Questioned by a shareholder about the Austrian decision, Baumann largely dismissed it, saying that farmers will have a difficult time getting by without glyphosate, one of the people said.
The meetings follow a vote against Baumann by shareholders at the company’s annual general meeting in April, where a majority of investors opposed absolving the CEO and other managers of responsibility for their actions in the Monsanto takeover.
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Biotech week ahead, July 8

Biotech stocks saw muted sentiment in the holiday-shortened week ending July 5 after a strong rebound in the later part of the previous week.
Activity was light, although news on clinical trial readouts continued to flow.
The following are catalytic events that could impact biotech stocks in the unfolding week:

Conferences

14th Euro-Global Gastroenterology Conference: July 8-9 in Zurich, Switzerland.

Clinical Trial Readouts

Intra-Cellular Therapies Inc ITCI 1.18% is scheduled to release top-line data from a Phase 3 study dubbed 401 that is evaluating its ITI-007 as a monotherapy for bipolar depression.
The company will also release top-line data from another late-stage study dubbed 404 that is evaluating ITI-007 as a monotherapy for bipolar depression.

Earnings

AngioDynamics, Inc. ANGO 0.99%: Wednesday, July 10 before the market open.
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Diabetes Medications Increase Fracture Risk

Insulin, thiazolidinedione, and sulphonylureasmay be associated with a greater risk of fracture, a new study has found.
Patients with diabetes mellitus (DM) have increased morbidity and mortality rates, according to the study authors, and some research has suggested they have a greater likelihood of fracture. “While the biological mechanisms underlying the positive association between DM and the risk of fracture remain largely obscure, a higher propensity of falling, impairment of bone quality, and direct or indirect treatment effects of glucose‐lowering medications on bone have been suggested to explain the elevated risk of fracture among DM patients,” they reported in their meta-analysis, published in Obesity Reviews. And while past studies have found a link between thiazolidinedione and fracture, data are limited on the association between thiazolidinedione as well as insulin, sulphonylureas, and metformin and fracture.
The researchers queried PubMed and Web of Science databases for relevant observational studies from inception through February using a combination of these search terms: (diabetes OR insulin OR glargine OR lispro OR biguanidine OR metformin OR thiazolidinediones OR pioglitazone OR rosiglitazone OR sulfonylureas OR sulphonylureas OR acetohexamide OR carbutamide OR chlorpropamide OR glycyclamide OR metahexamide OR tolazamide OR tolbutamide OR glibenclamide OR glibornuride OR gliclazide OR glipizide OR gliquidone OR glisoxepide OR glyclopyramide OR glimepiride) and fracture.

Metformin May Be Safest Bet for Low Fracture Risk

The final analysis included 33 studies, of which 26 were cohort and seven were case-control studies. An estimated 345,133 fractures were reported in about 6,847,158 patients. Studies reported on the use of metformin (n = 12), insulin (n = 23), sulphonylureas (n = 10), and thiazolidinediones (n = 14). Fracture risk was increased among patients using insulin (relative risk [RR] 1.49, 95% confidence interval [CI] 1.29-1.73), sulphonylureas (RR 1.30, 95% CI 1.18-1.43), and thiazolidinediones (RR 1.24, 95% CI 1.13-1.35), while fracture risk was decreased among patients using metformin (RR 0.86, 95% CI 0.75-0.99).
When assessing fracture risk associated with different types of thiazolidinediones, RRs were similar between pioglitazone (1.38, 95% CI 1.23-1.54) and rosiglitazone (1.34, 95% CI 1.14-1.58) use.
“The positive association between insulin or thiazolidinedione use and the risk of fracture was attenuated to non‐significant in the studies that adjusted for certain variables (falls or previous fracture for insulin and osteoporosis/osteoporosis medications, steroid medications, or classic glucose‐lowering medications for thiazolidinediones); this result was possibly driven by the contradictory studies reporting a significant reduction in risk with the use of insulin and thiazolidinediones, as the associations became significant after exclusion of these studies (data not shown),” the researchers further observed. “Furthermore, the association between thiazolidinedione use and the risk of hip fracture became significant (RR 1.21, 95% CI 1.03, 1.43) after exclusion of a contradictory study.”
The study authors concluded that thiazolidinedione use should be discouraged among patients at a high risk of fracture. Insulin and sulphonylurea use may increase fracture risk as well, “which is most likely attributed to an increased risk of hypoglycaemia‐induced falls,” they said. Therefore, when prescribing insulin and sulphonylureas, a patient’s risk of hypoglycemia should be considered. Metformin appeared to have a good safety profile in terms of fracture risk. Still, the researchers called for randomized controlled trials to determine whether certain medications do increase fracture risk or if other confounding factors are at play.
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Mixed shelf filing roundup – healthcare

The following healthcare companies have filed prospectuses for mixed shelf offerings:
Translate Bio (NASDAQ:TBIO): $250M.
Cellular Biomedicine Group (NASDAQ:CBMG): $200M.
Iterum Therapeutics (NASDAQ:ITRM): $150M.
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Glucose Biosensor Systems (Greater China) Holdings readies IPO

Glucose Biosensor Systems (Greater China) Holdings (GBSG) has filed a prospectus for a $23M IPO.
The New York City-based medical tech company plans to launch its Saliva Glucose Biosensor test in Mainland China, Hong Kong, Vietnam and Bangladesh, followed by tests for prostate specific antigen, peanut allergen and luteinizing hormone.
The Saliva Glucose Biosensor test, a non-invasive method of measuring glucose, is based on an electrochemical reaction that produces an electrical signal that is directly proportional to the amount of glucose in the saliva. A smart phone app converts the signal into a real-time glucose reading that can be stored in the company’s cloud-based digital information system.
Financials (nine-month period ending March 31, 2019): Sales: $114.0K; Net Loss: ($4.2M); Cash Consumption: ($3.1M).
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Rapt Therapeutics files for IPO

Rapt Therapeutics (OTC:RAPT) has filed a preliminary prospectus for an $86M IPO.
The South San Francisco-based biopharma firm develops small molecule therapies for cancer and inflammatory disorders that it says modulate the critical immune responses underlying the diseases.
Lead oncology candidate is FLX475, a CCR4 antagonist that blocks the migration of immunosuppressive regulatory T cells into tumors. Proof-of-concept data should be available in H1 2020.
Lead inflammation candidate is RPT193, also a CCR4 antagonist, that blocks the recruitment of inflammatory immune cells called type 2 T helper cells that play a key role in allergic inflammatory diseases. A Phase 1 study in atopic dermatitis should launch in H2.
2019 Financials (Q1): Operating Expenses: $9.5M (+14.1%); Net Loss: ($9.2M) (-11.6%); Cash Burn: ($8.6M) (-13.4%).
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