On January 10, 2019 Black Diamond Therapeutics, Inc., a biotechnology company developing next-generation precision medicines for cancer, reported the completion of an oversubscribed Series B financing of $85 million co-led by New Enterprise Associates and RA Capital Management (Press release, Black Diamond Therapeutics, JAN 10, 2019, View Source [SID1234532915]). Additional new investors NexTech Invest, The Invus Group and Perceptive Advisors joined founding investor Versant Ventures in the round. Following Black Diamond’s recent debut after operating in stealth mode in Versant’s Basel-based Ridgeline Discovery Engine, the company now has raised $105 million.

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Proceeds from the financing will be used to accelerate the development of Black Diamond’s pipeline and to expand its mutation, allostery and pharmacology (MAP) computational and discovery platform for identifying and targeting allosteric oncogenic mutations. Specifically, the round will allow the company to establish its new corporate headquarters in Cambridge, MA, advance two-to-three existing development candidates into the clinic in the next 24 months, and bolster its platform’s ability to rapidly identify precision medicines for mutant cancers intractable to standard care.

"We are pleased to have such strong support from this syndicate of blue-chip investors who recognize our potential to discover and produce transformative therapies that will help millions of people with cancer based on our unique and powerful MAP platform," said David Epstein, Ph.D., president and CEO of Black Diamond. "We are now well-resourced to advance our lead programs and set the course for clinical success."

In connection with the Series B round, NEA’s Ali Behbahani, M.D., and RA Capital’s Rajeev Shah joined Black Diamond’s Board of Directors. They join existing board members Dr. Epstein and Versant’s Brad Bolzon, Ph.D., and Alex Mayweg, Ph.D.

"Black Diamond has tremendous potential to usher in the next step-change in targeted cancer therapies, and this investment represents a chance to build a new type of precision medicine oncology company," said Dr. Behbahani.

Mr. Shah added, "The approach that Black Diamond is taking offers the potential to reshape and extend the pipeline of precision oncology medicines available to oncology patients, and we see a great growth opportunity here."

Black Diamond’s MAP platform has generated a pipeline of five programs, including three that have progressed compounds through lead optimization or into IND-enabling studies. The fourth and fifth programs are in lead identification. Black Diamond’s first two disclosed programs are targeting groups of EGFR and HER2 allosteric mutants.

Black Diamond’s MAP: a unique platform

Black Diamond’s industry-leading MAP platform identifies and drugs allosteric mutant disease targets. Oncogenes are activated by kinase domain mutations or by allosteric mutations. While kinase domain mutations have been successfully drugged with selective inhibitors and are standard of care in many malignancies, allosteric mutations represent an undrugged and unexplored space.

As genomic profiling and sequencing of cancer patients is becoming standard, Black Diamond’s MAP can pinpoint new druggable mutation baskets from the thousands of lesions identified across genes and patients, and can create high-impact precision medicines. Some of the allosteric mutation baskets represent two-to-15 percent of patients in a given tumor tissue or across tumor sites.

On January 9, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported its 2019 financial guidance at the 37th annual JP Morgan Healthcare Conference (Press release, Halozyme, JAN 9, 2019, View Source [SID1234532605]).

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"Looking ahead, our ENHANZE business is gaining momentum with key product development milestones expected this year, including potential FDA approval of a subcutaneous formulation of Herceptin and regulatory submissions for the subcutaneous formulation of Darzalex each representing important near-term catalysts," said Dr. Helen Torley, president and chief executive officer. "In our oncology business, HALO-301 has completed enrollment and topline results are projected in the second half of 2019."

Halozyme provided an update on the 2019 outlook for its ENHANZE franchise. The company expects to make meaningful progress this year toward its projection of the potential for approximately $1 billion in royalty revenue in 2027. During the first quarter, FDA action is expected on the Biologics License Application (BLA) filed by ENHANZE partner Genentech, a member of the Roche Group, for the subcutaneous (SC) formulation of trastuzumab (Herceptin). In the second half of 2019, ENHANZE partner Janssen Biotech, Inc. anticipates filing for approval of the SC formulation of its multiple myeloma drug daratumumab (Darzalex). Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target.

By the end of 2019, the company expects three ENHANZE programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products. This accelerating partner activity supports the projection of the potential for approximately $1 billion in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be $1 billion, with $225 million to $300 million in revenues projected between 2019 and 2021.

The company also provided an update on its late stage targeted oncology asset PEGPH20. Enrollment in HALO-301, the company’s phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed at the end of 2018 with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS (overall survival) events between August and November of 2019. Based on this timeline, the company projects topline results will be available in the second half of 2019.

Halozyme and its partners continue to explore the pan-tumor potential of PEGPH20. This includes ongoing phase 1b studies in pancreas cancer, gastric cancer, gall bladder cancer and cholangiocarcinoma.

2019 Financial Guidance

The company also provided financial guidance for 2019:

Net revenue of $175 million to $185 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements.
Operating expenses of $265 million to $275 million, or $225 million to $235 million excluding an expected increase in cost of goods sold. Excluding the cost of goods sold the modest increase in expenses is driven by ENHANZE partner support, and support of the potential commercialization of PEGPH20.
Operating cash burn of $75 million to $85 million.
Debt repayment of approximately $90 million.
Year-end cash balance of $180 million to $190 million.
Table 1. 2019 Financial Guidance

Guidance Range

Net Revenue

$175 million to $185 million

Operating Expenses

$265 million to $275 million

Operating Expenses (excl. COGS)

$225 million to $235 million

Operating Cash Burn

$75 million to $85 million

Debt Repayment

~$90 million

Year-end Cash Balance

$180 million to $190 million

The company plans to report fourth quarter and full year 2018 financial results on February 21, 2019.

A replay of Dr. Torley’s presentation at the conference today can be accessed for the next 90 days via the "Investors" section of www.halozyme.com. Also, a copy of the presentation made today was filed with the Securities and Exchange Commission as part of a Form 8-K that can also be accessed via the "Investors" section of www.halozyme.com.

On January 9, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on schedule (Press release, Athenex, JAN 9, 2019, View Source;p=RssLanding&cat=news&id=2382773 [SID1234532606]). Athenex also reaffirms that top line data from the study is expected to be available in mid-2019.

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About Oraxol Phase III Study

Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor). The Oraxol Phase III study is an open-label, randomized, multicenter study to determine the safety, tolerability, and tumor response of Oraxol compared with IV paclitaxel in patients with metastatic breast cancer, with a target enrollment of 360 adult female patients. Secondary endpoints will measure progression-free survival and overall survival. More information about this study is available at www.clinicaltrials.gov.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi

On January 9, 2019 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported that its Board of Directors has appointed Brian Barnett, M.D., as Chief Executive Officer (Press release, Oncbiomune, JAN 9, 2019, View Source [SID1234532611]).

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Prior to joining the Company, Dr. Barnett served at Puma Biotechnology, Inc. since August 2016 ("Puma") most recently as a Vice President and Head of Medical Affairs. Prior to his time with Puma, Dr. Barnett was with Genentech, Inc., a subsidiary of Roche, from October 2012 to August 2016 and served as Medical Director, Kadcyla (T-DM1), Global Product Development Oncology and U.S. Medical Affairs. Prior to his appointment as CEO, Dr. Barnett was a member of the Company’s Scientific Advisory Board. Dr. Barnett received his B.S. from Millsaps College, M.D. from the University of Mississippi Medical Center, and completed his Medical Oncology Fellowship at Tulane University in New Orleans.

Dr. Barnett succeeds Dr. Jonathan Head as Chief Executive Officer at OncBioMune. Dr. Head will continue to serve the Company as the Chairman of the Board of Directors and now as its Chief Scientific Officer.

"It has long been our strategy to advance ProscaVax into mid-stage clinical trials for prostate cancer and find my successor from big pharma to lead our continued growth and pipeline development," commented Dr. Head. "Dr. Barnett was a natural choice given his experience at Puma and Genentech and understanding of our pipeline through his time as an advisor to the Company. I am confident that the Company is going to benefit from Dr. Barnett’s passion for drug development, business savvy and industry connections and I am thrilled to introduce him as our new CEO."

"I am excited and honored to take this opportunity to lead OncBioMune and spearhead development of our pipeline of exceptional drug candidates," said Dr. Barnett. "As an oncologist and as I’ve gotten to know the company more intimately, I see the opportunities that are presented with ProscaVax, the platform vaccine technology and our patented targeted transferrin transport technology. As we move forward with the Phase 2 trials of ProscaVax, I intend to focus on and expedite development of the transferrin technology simultaneously. This is an underappreciated part of our pipeline that I believe can possibly help cancer patients by addressing an unmet need and will resonate potentially as a tumor-agnostic, biomarker-directed and targeted approach to cancer therapy."

As previously announced, OncBioMune intended to host a shareholder call in December. With change in leadership, the company is rescheduling the call for later this quarter to give Dr. Barnett some time to get acclimated to his new position.

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On January 9, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the pricing of an underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $0.225 per share (Press release, BioServe Biotechnologies, JAN 9, 2019, View Source [SID1234532612]). Cancer Genetics also granted the underwriter a 45-day option to purchase up to an additional 2,000,000 shares of its common stock at the public offering price of $0.225 per share, less underwriting discounts and commissions. Cancer Genetics expects to receive aggregate gross proceeds of approximately $3.0 million from the offering, assuming no exercise of the underwriter’s option to purchase additional shares. The offering is expected to close on or about January 14, 2019, subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Cancer Genetics intends to use the net proceeds from the offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements it is negotiating with its banks, to pay certain costs previously incurred by it in connection with its terminated transaction with NovellusDx Ltd., and if any proceeds remain available, to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering was filed with the SEC on January 9, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.