Gilead Sciences to Release First Quarter 2019 Financial Results on Thursday, May 2, 2019

On April 18, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its first quarter 2019 financial results will be released on Thursday, May 2, after the market closes (Press release, Gilead Sciences, APR 18, 2019, View Source [SID1234535248]). At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the first quarter 2019 and provide a business update.

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The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 5259422 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, May 4, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 5259422. The webcast will be archived on www.gilead.com for one year.

Heat Biologics CEO to Present at the ThinkEquity Conference in New York City

On April 18, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that Jeff Wolf, Chief Executive Officer, is scheduled to present at the ThinkEquity Conference on Thursday, May 2nd, at 8:00 AM Eastern Time, which is being held at The Mandarin Oriental Hotel in New York City (Press release, Heat Biologics, APR 18, 2019, View Source [SID1234535223]).

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Additional information on the conference is available at, View Source

AMERICAN CANCER SOCIETY’S NEWLY FORMED PHILANTHROPIC IMPACT FUND MAKES FIRST INVESTMENT

On April 18, 2019 Castle Biosciences, Inc. and American Cancer Society’s newly formed philanthropic fund, BrightEdge, reported that BrightEdge participated in a recent convertible note financing of Castle Biosciences of approximately $12 million (Press release, Castle Biosciences, APR 18, 2019, View Source [SID1234535222]). The investment is BrightEdge’s first since its formation to invest in companies developing promising cancer-related therapeutics, diagnostics, devices and technologies.

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Castle Biosciences is a commercial stage dermatological cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. Last year, the company processed tests for more than 13,000 patients. To date, it has received over 40,000 diagnostic orders.

"Since the company’s founding in 2008, we have developed and commercialized what we believe are some of the industry’s most innovative skin cancer diagnostics designed to improve treatment options and, ultimately, patient outcomes," said Castle Biosciences’ founder, president and CEO Derek Maetzold. "As the recipient of BrightEdge’s first investment, we are more committed than ever to the mission we share with the American Cancer Society to fight for a world without cancer."

Castle Biosciences’ lead product, DecisionDx-Melanoma, is a proprietary gene expression profile (GEP) test designed to help doctors assess treatment options for patients with invasive cutaneous (skin) melanoma. The company also markets DecisionDx-UM, a GEP test that predicts metastatic risk for patients with uveal melanoma, a rare and deadly eye cancer. Both are commercially approved and covered by several private insurers. Medicare recently approved both tests for reimbursement coverage under policies administered by two of its insurance contractors, Palmetto GBA and Noridian Healthcare Solutions.

"The significance of this investment goes well beyond simply representing BrightEdge’s first deal," said Bob Crutchfield, managing director of BrightEdge. "Castle Biosciences met the key criteria of our new impact fund. It both has potential to deliver a strong financial return and moves us forward in BrightEdge’s ultimate mission to drive innovation and win the fight against cancer."

The American Cancer Society expects to raise an additional $100 million from private donors to augment its initial $25 million commitment to BrightEdge to make mission investments that advance innovation.

About BrightEdge

BrightEdge is the American Cancer Society’s donor-funded, philanthropic impact fund. The fund is led by a board comprised of the Society’s leaders and a management team with expertise in investment and venture capital. BrightEdge operates under a charitable fund model that invests in for-profit companies developing novel cancer-focused therapies and technologies. The fund relies on the expertise of the Society’s medical and science professionals to evaluate the mission value of its investments. The fund’s goal is to accelerate delivery of promising cancer-related solutions through capital investment, market awareness and a shared commitment to eradicate cancer. BrightEdge is based in Atlanta. For more information, visit www.brightedgefund.org.

(The American Cancer Society is the sole member of BrightEdge, LLC. An investment or other finance vehicle does not constitute an expressed or implied endorsement of any products or services of the company.)

About the American Cancer Society

The American Cancer Society is a global grassroots force of 1.5 million volunteers dedicated to saving lives, celebrating lives, and leading the fight for a world without cancer. From breakthrough research, to free lodging near treatment, a 24/7/365 live helpline, free rides to treatment, and convening powerful activists to create awareness and impact, the Society is the only organization attacking cancer from every angle. For more information, go to www.cancer.org.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a GEP test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied on more than 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes.

The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including more than 780 patients. The consistent high performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multicenter and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

Emergent BioSolutions to Release First Quarter 2019 Financial Results and Conduct a Conference Call on May 2, 2019

On April 18, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, May 2, 2019 at 5:00 pm (Eastern Time) to discuss the financial results for the first quarter of 2019, recent business developments, revenue guidance for the second quarter of 2019, and financial outlook for full year 2019 (Press release, Emergent BioSolutions, APR 18, 2019, View Source;p=RssLanding&cat=news&id=2394937 [SID1234535221]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 8099738

Live Webcast Information:
Visit View Source for the live webcast feed.
A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

Dynavax to Present Data on Toll-like Receptor 9 Agonist SD-101 at the ASCO Annual Meeting 2019

On April 18, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present data from a Phase 1b/2 combination study of SD-101 and pembrolizumab for patients with advanced melanoma and for patients with recurrent or metastatic head and neck squamous cell carcinoma, at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31 – June 4 in Chicago (Press release, Dynavax Technologies, APR 18, 2019, View Source [SID1234535220]).

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Abstract Number and Title: #6039, "Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naive patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)"
Poster Session Title: Head and Neck Cancer
Session Date and Time:Sat, Jun 01, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #28

Abstract Number and Title: #9534, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy"
Poster Session Title: Melanoma/Skin Cancers
Session Date and Time:Mon, Jun 03, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #105

Abstract Number and Title: #9555, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy"
Poster Session Title: Melanoma/Skin Cancers
Session Date and Time:Mon, Jun 03, 1:15 PM – 4:15 PM
Session Location:McCormick Place, Exhibit Hall A, Poster Board Number: #126

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.