8-K – Current report

On March 18, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that it has priced an underwritten public offering of 9,100,000 shares of its common stock and warrants to purchase up to an aggregate of 6,825,000 shares of its common stock at a combined public offering price of $0.75 per share and related warrant (Filing, 8-K, Heat Biologics, MAR 18, 2016, View Source [SID:1234509646]). Each share of its common stock is being sold together with a warrant to purchase 0.75 of a share of its common stock. The gross proceeds from this offering to Heat are expected to be approximately $6.8 million, before deducting the underwriting discount and estimated offering expenses payable by Heat, but excluding the exercise of any warrants.

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The shares of common stock will be immediately separable from the warrants and will be issued separately. The warrants are exercisable immediately upon issuance, expire five years after the date of issuance and have an exercise price of $1.00 per share. The warrants will be certificated and will be delivered to the investors by physical delivery following the closing. There is no established public trading market for the warrants and Heat does not expect a market to develop.

The offering is expected to close on or about March 23, 2016, subject to customary closing conditions.

Heat intends to use the net proceeds from the offering to complete its Phase 2 clinical trial evaluating HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC), which remains Heat’s primary focus. The remaining net proceeds will be used to advance the current eight patients enrolled in Heat’s Phase 1b clinical trial evaluating HS-110 for the treatment of non-small cell lung cancer (NSCLC) through the reporting of topline data, as well as for licensing or acquisition of assets complementary to its existing programs and for general corporate and working capital purposes.

Roth Capital Partners and Aegis Capital Corp. acted as joint book-running managers and Noble Financial Capital Markets acted as co-manager for this offering.

A registration statement on Form S-1 relating to the shares of common stock and warrants described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). This offering is being made only by means of a prospectus forming a part of the effective registration statement. Copies of the final prospectus may be obtained from Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, Attention: Equity Capital Markets, or by telephone at 800-678-9147, or by email at [email protected], or from Aegis Capital Corp., 810 7th Avenue, 18th Floor, New York, NY 10019 or via telephone at 212-813-1010 or email at [email protected], or by accessing the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The Myriad myRisk® Hereditary Cancer Test Identifies 60 Percent More Deleterious Mutations in Patients with Endometrial Cancer

On March 18, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported it will present two important new studies at the 2016 Society for Gynecologic Oncology annual meeting in San Diego, Calif (Press release, Myriad Genetics, MAR 18, 2016, View Source [SID:1234509630]).

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The data demonstrate the ability of the myRisk Hereditary Cancer test to identify deleterious mutations in patients with endometrial cancer. Additionally, a different study showed the superior ability of the combined three biomarker myChoice HRD test to predict survival in patients with platinum treated ovarian cancer.

"Endometrial cancer is the most frequent gynecologic cancer and a significant number of these cases are due to mutations in hereditary cancer genes," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "Our new data show that gene panel testing can identify many more patients with harmful mutations than testing Lynch Syndrome genes alone. The additional information provided by the myRisk Hereditary Cancer test will help physicians optimize care for their patients."

Details about the featured Myriad presentations at SGO are below. Follow Myriad on Twitter via @MyriadGenetics and stay up-to-date with the meeting by using the hashtag #SGOMtg.

myRisk Hereditary Cancer Presentation — Endometrial Cancer

Title: Hereditary cancer panel testing in an unselected endometrial carcinoma cohort.
Date: Saturday, March 19, 2016: 7:50 to 9:55 a.m. PT.
Location: Podium — Abstract 6261.
Presenter: Kari Ring, MD Anderson Cancer Center.

This study evaluated the prevalence of cancer predisposition gene mutations in 381 endometrial cancer patients who had previously undergone tumor testing to screen for Lynch Syndrome. Patients were tested for mutations in 25 cancer genes using the myRisk Hereditary Cancer test. The results showed that 9.2 percent of endometrial cancer patients had a deleterious mutation, including 5.8 percent with a mutation in a Lynch Syndrome gene and 3.4 percent in 10 non-Lynch genes. Multi-gene panel testing with myRisk demonstrated the ability to identify 60 percent more mutations, several of which are associated with ovarian and uterine cancers. These findings support gene panel testing to identify patients who may be missed by current Lynch Syndrome testing alone.

myChoice HRD Presentation

Title: Homologous recombination deficiency (HRD) score shows superior association with outcome compared to its individual score components (LOH, TAI and LST) in platinum treated serous ovarian cancer.
Date: Saturday, March 19, 2016: 7:50 to 9:55 a.m. PT.
Location: Podium — Abstract 6286.
Presenter: Gordon B. Mills, M.D., Ph.D., MD Anderson Cancer Center.

This study compared the predictive ability of the combined three biomarker myChoice HRD score to the three independent measures of homologous recombination deficiency that comprise the assay including: loss of heterozygosity (LOH) score, telomeric-allelic imbalance (TAI) score, and large-scale state transitions (LST) score. The results showed that the combined myChoice HRD score predicted progression-free survival (p=2.2×10-6) and overall survival (p=1.0×10-8) in patients with platinum-treated ovarian cancer. In a bivariate analysis none of the individual biomarkers (LOH, TAI and LST) reached statistical significance for either progression free survival or overall survival. In this study, myChoice HRD was shown to be a superior predictor of clinical outcomes to any of the individual score components including LOH, TAI and LST.

About Myriad myRisk Hereditary Cancer Testing
The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: myriad.com.

About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. For more information visit: myriad.com.

Alligator presents at Carnegie Healthcare Seminar

On March 17, 2016 Alligator presented the corporate presentation (Presentation, Alligator Bioscience, MAR 17, 2016, View Source [SID1234538697]).

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Dave Chiswell appointed Kymab CEO

On March 17, 2019 Kymab reported that Dr David Chiswell OBE has been appointed as Chief Executive Officer with effect from April 2016 (Press release, Kymab, MAR 17, 2016, View Source [SID1234537012]). Dr Chiswell has acted as interim CEO since early 2015, having been appointed Chairman in September 2013. Dr Tim Rink will take the role of Lead Director with effect from April.

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Dr Chiswell has an enviable record in the industry, having worked at Amersham, founded Cambridge Antibody Technology in 1990, been Chair of the UK’s BioIndustry Association, and served seven other biotech companies as Chairman or Director.

"I am delighted with Dave’s appointment as CEO; Dave has an outstanding track record and experience in antibody development and building Biotech companies," said Dr Rink. "He was instrumental in the development of the world’s best selling antibody, Abbvie’s HUMIRA (Adalimumab), which was launched in 2003 and has annual sales in excess of $14 billion."

"I have spent one of the most satisfying years of my career as interim CEO working closely with the excellent team at Kymab," said Dr Chiswell. "I believe Kymab has all the tools needed to enable it to become a truly successful major Biotech company. Our Kymouse platform has already generated an enviable product pipeline of human monoclonal antibodies which we will continue to expand.

"We attracted high quality investors Woodford and Malin alongside the Wellcome Trust and the Bill & Melinda Gates Foundation in our US$90 million Series B fund raise, one of the largest pre-clinical rounds in UK biotech. We have established major partnerships such as Novo Nordisk and the US cancer hospital MD Anderson.

"I am very pleased to be taking the helm on a permanent basis at a time when we are commencing our clinical trial programmes."

Dr Chiswell has over 30 years’ experience in the biotechnology industry having co-founded Cambridge Antibody Technology (CAT) in 1990, serving as CEO from 1996 to 2002. CAT listed on the London Stock exchange in April 1997 and Nasdaq in June 2001, and was subsequently sold to AstraZenca where it forms an important part of their biopharmaceutical franchise.

Since leaving CAT in 2002, he has focused on the development of early-stage biotechnology companies, having previously served as a director of Arakis, non-executive chairman of Sosei, Arrow Therapeutics and Daniolabs, and as CEO of Nabriva Therapeutics (2009 to 2012). Dr Chiswell currently serves as chairman of Albireo Pharma and is a director of Nabriva Therapeutics.

He is a past chairman of the UK BioIndustry association (BIA) and in 2006 he was awarded the Most Excellent Order of the British Empire (OBE) by Her Majesty the Queen for services to the biotechnology industry.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Adaptimmune, 2015, MAR 17, 2016, View Source [SID:1234509607])

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