On February 7, 2019 HiberCell, a biotechnology company developing therapeutics focused on preventing cancer relapse and metastasis, reported with $60.75M in Series A funding led by ARCH Venture Partners (Press release, HiberCell, FEB 7, 2019, View Source [SID1234533195]). HiberCell is the first company exclusively focused on tumor dormancy detection and therapeutics.

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Most patients who succumb to cancer do so because of metastatic cancer. Accumulated evidence has demonstrated that cancer recurrence is driven by dormant disseminated tumor cells (DTCs) that persist undetected in the body for prolonged periods of time. In approaching cancer as a systemic disease, the company seeks to detect and therapeutically target the ‘Achilles heel’ of patient DTCs to prevent or delay metastasis. The company is developing first-in-class therapeutics targeting DTCs originating from solid and liquid cancers.

"HiberCell is the foundational tumor dormancy company," said Alan Rigby, Ph.D., co-founder, president and chief scientific officer. "We know that dormant disseminated tumor cells are critical drivers of cancer metastasis. In translating this biology into the clinic, our work will be focused on further defining the characteristic genetics and transcriptomics of dormant disseminated tumor cells and charting a course to leverage our dormancy therapies to improve patient outcomes and survival. We believe that this approach provides a differentiated opportunity to change the paradigm of cancer treatment."

"While we have made great strides in treating primary tumors, the unfortunate and painful truth is that relapsed or metastatic cancer still claims the lives of most people with cancer, even when their primary tumor has been successfully treated," said Julio Aguirre-Ghiso, Ph.D., HiberCell’s scientific founder and professor of Medicine (Hematology and Medical Oncology), director of Head and Neck Cancer Basic Research and Solid Tumor and Metastasis Research and co-leader of the Cancer Mechanisms Program at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. "HiberCell will build on the foundational biology that is in place by focusing on novel tools to better detect, isolate and annotate the survival mechanisms in these dormant disseminated tumor cells. By targeting these mechanisms with therapeutics, we believe it is possible to extend disease-free intervals and improve the chance of survival through lower rates of relapse and metastasis."

"We’re launching HiberCell at an exciting time for cancer treatments," said Ari Nowacek, principal at ARCH Venture Partners. "Recent advances in cancer treatment that take advantage of a patient’s immune system are providing prolonged survival advantages to patients, but cancer metastasis represents a significant unmet medical need across the cancer landscape."

In addition to backing from ARCH Venture Partners, investors include Hillhouse Capital, 6 Dimensions Capital, Celgene Corporation, the NYC Life Sciences Fund and undisclosed institutional investors, family offices and private individuals.

HiberCell represents a significant investment by the NYC Life Sciences Fund. Established by the New York City Economic Development Corporation, the Fund is at the forefront of initiatives designed to champion New York City’s early-stage life sciences ecosystem. Separately, Dr. Aguirre-Ghiso received the 2016 BioAccelerate Prize for work that has been licensed by HiberCell. The Prize is awarded by the Partnership Fund for New York City to provide funding for the commercialization of research at New York academic institutions.

"HiberCell exemplifies the high caliber innovation that New York’s life sciences ecosystem can support and foster," said James Patchett, president and CEO of NYCEDC. "The HiberCell team has the scientific and financial backing needed to advance cutting-edge science and make a meaningful difference in cancer patients’ lives. NYCEDC is proud to foster that kind of work here in New York City."

"HiberCell is slated to be one of the more prominent academic new ventures in New York City this year, and demonstrates Mount Sinai’s commitment to developing innovative therapies," said Erik Lium, Ph.D., executive vice president of Mount Sinai Innovation Partners. "This groundbreaking partnership between HiberCell’s leadership team, Mount Sinai, ARCH Venture Partners, the NYCEDC and other prominent investor groups seeks to bring novel therapies to the fight against cancer."

HiberCell will occupy state-of-the-art lab and office space in The Hudson Research Center, a partnership between Taconic Investment Partners and Silverstein Properties located at 619 West 54th Street.

Leadership Team

HiberCell’s rapidly expanding, multidisciplinary team consists of world-class cancer scientists, venture capitalists and drug developers who are leaders within their respective fields. At launch, Alan Rigby, Ph.D., will lead the company as president and chief scientific officer. Ari Nowacek, Ph.D., M.D., principal at ARCH Venture Partners, will serve as vice president of operations and business development, and Mark Mulvihill, Ph.D., will serve as vice president of chemistry and drug discovery.

Board of Directors

Steven Gillis, Ph.D., chairman of the board at HiberCell, managing director at ARCH Venture Partners
Alan Rigby, Ph.D., president and chief scientific officer at HiberCell
Ari Nowacek, M.D., Ph.D., principal at ARCH Venture Partners & vice president, operations and business development at HiberCell
Kevin Heyeck, Ph.D., venture partner at 6 Dimensions Capital
Michael Yi, Ph.D., partner at Hillhouse Capital
Scientific Advisory Board

Julio Aguirre-Ghiso, Ph.D., director of Solid Tumor and Metastasis Research, director of Head and Neck Cancer Basic Research, co-leader of the Cancer Mechanisms Program and professor of Oncological Sciences, Otolaryngology, and Medicine (Hematology and Medical Oncology) at The Tisch Cancer Institute at the Icahn School of Medicine
Christoph Klein, M.D., Ph.D., head of the Department of Experimental Medicine and Therapy Research at the University of Regensburg, head of Personalized Tumor Therapy, a division of Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Ruggero De Maria, M.D., professor and director of the Institute of General Pathology at the Catholic University of Rome, president of the Italian Institute for Genomic Medicine in Turin, Italy and president of the Italian Alliance Against Cancer network

On February 7, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported the publication of a study highlighting the ability of the DecisionDx-Melanoma test to accurately determine risk of metastasis in patients with melanoma of the head and neck (Press release, Castle Biosciences, FEB 7, 2019, View Source [SID1234533121]). Results from the study demonstrated that the DecisionDx-Melanoma test can provide independent information about recurrence risk in patients with tumors of the head and neck region, and can improve the evaluation of prognosis when used in combination with sentinel lymph node (SLN) status, especially in patients with a negative SLN biopsy. The study was published in the journal Head and Neck.

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Melanoma tumors in the head and neck region are associated with lower SLN positivity rates compared to tumors located on the trunk or extremities. There is also a higher rate of recurrence among SLN-negative patients with melanoma of the head and neck. Thus, improved methods for determining prognosis in patients with head or neck melanoma are needed.

"Tumors of the head and neck region can pose clinical challenges for traditional prognostic methods such as the SLN biopsy procedure," said lead author Brian Gastman, M.D., Cleveland Clinic Lerner Research Institute, Cleveland, Ohio. "In this study, the DecisionDx-Melanoma test accurately and independently determined prognosis for patients with melanoma of the head and neck. Importantly, the test can complement traditional AJCC staging methods and SLN status to identify high-risk patients who could potentially benefit from more aggressive surveillance and earlier therapeutic intervention at a time when these treatments can be more effective."

Study Details and Key Findings:

157 patients with Stage I, II or III melanoma of the head or neck had a median age of 65 years and median Breslow thickness of 1.6 mm. The median time to recurrence was 1.4 years and the median follow-up time was 7.1 years for patients who did not experience recurrence.
The DecisionDx-Melanoma test was performed to determine molecular class for each patient, with a Class 1A result indicating the lowest 5-year risk of metastasis and a Class 2B result indicating the highest risk.
Patients who were identified as Class 1A (lowest risk) by the DecisionDx-Melanoma test had higher recurrence-free (RFS), distant metastasis-free (DMFS) and melanoma-specific survival (MSS) rates compared to those in the SLN-negative group (80%, 83% and 98% compared to 65%, 69% and 89%, respectively).
Patients identified as Class 2B (highest risk) by the DecisionDx-Melanoma test had 5-year RFS, DMFS and MSS rates of 25%, 33% and 61%, respectively, which closely aligned with those of the SLN-positive group (20% RFS, 28% DMFS and 61% MSS, respectively).
The DecisionDx-Melanoma test demonstrated better sensitivity for identifying recurrence (74%), distant metastasis (74%) and melanoma-specific mortality (88%) than SLN biopsy alone (41%, 40% and 52%, respectively).
Similarly, the negative predictive values (NPV) for identifying recurrence (76%), distant metastasis (78%) and melanoma-specific mortality (96%) were superior to those for node positivity (64%, 67% and 90%, respectively).
When results from the DecisionDx-Melanoma test were combined with nodal status, the combination showed a sensitivity for RFS of 81%, DMFS 80% and MSS 88%, similar to those for the DecisionDx-Melanoma test alone but substantially improved over sensitivity for SLN biopsy alone.
Cox multivariate analysis comparing the DecisionDx-Melanoma Class 2 result to American Joint Committee on Cancer (AJCC) Stage IIB and above showed that both classifications were significant predictors of recurrence and distant metastasis (p≤0.006 for both endpoints), but only the Class 2 result was significant for melanoma-specific death (p=0.005).
The full published study results can be accessed at the Head and Neck website.

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

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

On February 7, 2019 Harpoon Therapeutics, Inc. ("Harpoon"), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported the pricing of its initial public offering of 5,400,000 shares of its common stock at a price to the public of $14.00 per share (Press release, Harpoon Therapeutics, FEB 7, 2019, View Source [SID1234533138]). The gross proceeds to Harpoon from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Harpoon, are expected to be $75.6 million. The shares are expected to begin trading on the Nasdaq Global Select Market on February 8, 2019 under the symbol "HARP." The offering is expected to close on February 12, 2019, subject to customary closing conditions. In addition, Harpoon has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock.

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Citigroup and SVB Leerink are acting as joint book-running managers for the offering. Canaccord Genuity and Wedbush PacGrow are acting as co-managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on February 7, 2019. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected].

This press release shall 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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On February 7, 2019 Advaxis presented the Corporate Overview Presentation (Presentation, Advaxis, FEB 7, 2019, View Source [SID1234533176]).

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On February 7, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), reported financial results for the fiscal 2019 first quarter ended December 31, 2018 (Press release, Applied DNA Sciences, FEB 7, 2019, View Source [SID1234533122]).

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"Our performance for the quarter reflects a consistent year-over-year foundation to our cotton business and continued execution under our multi-year contracts with the U.S. Department of Defense, as well as further progress made on our joint development agreements with partners in cannabis and pharmaceuticals," said Dr. James A. Hayward, president and chief executive officer of Applied DNA. "During the quarter we saw the first CertainT-certifiable synthetics home textiles products committed by retailers, a bellwether milestone for other manufacturers of CertainT synthetics in our pipeline. We also moved to refine our go-to-market and partnering strategy to drive tighter focus on select verticals and geographies.

"In our LineaRx subsidiary, we continued the development of linear DNA for nucleic acid-based therapies that have already shown promising early results in the field of adoptive T-cell therapy and nucleic-acid-based vaccine, and continued sponsored R&D on behalf of contract research customers. LineaRx customers are increasing in number and diversity and we are starting to see greater than typical dollar-value opportunities enter the pipeline," continued Dr. Hayward. "In addition to its therapeutics work, subsequent to the close of the quarter, the Company received a purchase order in excess of $500,000 for linear DNA in diagnostics to be delivered over the next 12-18 months. We continue to make strong technical progress on our proprietary non-viral, plasmid-free CAR-T platform, with early promising results in the high-throughput transfection of human T-cells with linear DNA."

"Subsequent to the close of the quarter, we announced two non-binding MOUs to enter the Asian supply chain market in Taiwan: with Sun Chemical Supply Co. Ltd ("Sun Chemical") that offers us geographic and domain knowledge in selling and supporting textile manufacturers in China and other Asian countries; and with Tex-Ray Industrial Co., Ltd ("Tex-Ray"), a world-leading innovator and supply chain integrator in performance fibers and fabrics that gives us entrée to supply chains spanning three continents and serving global brands. To help shape the go-to-market strategy and business development efforts and to accelerate our sales cycle, we appointed Stephen Birkhold to our Strategic Advisory Board, who brings a long and stellar history in brand management to hone our strategy in this market.

Concluded Dr. Hayward, "In our cannabis and pharmaceutical businesses, we are progressing towards commercialization by putting in place the necessary operational and marketing infrastructure to enable our partners TheraCann and Colorcon to fully engage our respective, joint customer bases. In particular, our TheraCann partnership is positioning us at the forefront of a burgeoning industry, which we believe needs a safe and secure way to manage the legal cannabis supply chain. Our taggant technology is an integral component of TheraCann’s ETCH Biotrace seed-to-sale solution, and we believe we are well positioned to international markets."

Fiscal First Quarter 2019 Financial Results:

Revenues increased 37% for the first quarter of fiscal 2019 to $884 thousand, compared with $648 thousand reported in the first quarter of fiscal 2018, and decreased 26% from the $1.2 million reported in the fourth fiscal quarter ended September 30, 2018. The year-over-year increase in revenues was due primarily to an increase in service revenues of $265 thousand. The increase in service revenue as compared to the same period in the prior fiscal year was the result of increases in our pharmaceuticals and nutraceutical market for pre-commercial pilots as well as an increase for our cannabis systems development and go-to-market initiative. The quarter-over-quarter decrease in revenues reflects a change in revenue recognition accounting standard for cotton DNA actually shipped at quantities roughly equal to last year, as detailed below.
Effective October 1, 2018, the Company was required to adopt Accounting Standards Update (ASU; the "Update") No. 2014-09, Revenue from Contracts with Customers (Topic 606), utilizing the modified retrospective method. Had the Company not adopted the Update, the Company would have recognized additional revenue of approximately $391,000 during the first quarter of fiscal 2019. This amount was primarily comprised of the recognition of $383,000 under a $1.15 million cotton order shipped in June 2018. The total cumulative impact of the Update that was recorded to opening retained earnings in fiscal 2019 was approximately $495,000. See Cumulative Effect Adjustment and the Impact on Current Period Financial Statements of Adopting Topic 606 attached.
Total operating expenses increased to $3.9 million for the first fiscal quarter of 2019, compared with $3.5 million in the prior fiscal year’s first quarter. This increase is primarily attributable to an increase in stock-based compensation expense.
Net loss for the quarter ended December 31, 2018 was $3.2 million, or $0.11 per share, compared with a net loss of $3.2 million, or $0.12 per share, for the quarter ended December 31, 2017 and a net loss of $3.5 million, or $0.12 per share for the quarter ended September 30, 2018.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.6 million for the quarter ended December 31, 2018 and $2.8 million for the same quarter in the prior fiscal year.
Select Recent Operational Highlights:

In early February 2019, Applied DNA received a purchase order to ship over $500,000 of diagnostic DNA amplicon in partial shipments over the next 12-18 months.
On February 6, 2019, the Company announced that cannabis partner TheraCann International and Israeli Cannabis ("iCAN") had in November 2018 signed a bilateral agreement that enabled iCAN to market TheraCann’s ETCH Biotrace solution that is based, in part, on Applied DNA’s CertainT platform. This bilateral agreement potentially catalyzes the use of Applied DNA’s technology in exported Israeli cannabis.
On January 29, 2019, Applied DNA appointed Stephen Birkhold to its Strategic Advisory Board. Birkhold, a 30-year veteran of the fashion industry, will lead the development of a new sales, marketing and go-to-market strategy for the Company’s technology platform in the fashion and luxury apparel and accessory markets. Birkhold is the former CEO of several of the world’s most prominent apparel brands, including Bebe Stores, Lacoste, Diesel and Earl Jeans, along with achieving a 10-year tenure at VF Corporation working with Lee Jeans and Nautica Jeans.

On January 28, 2019, the Company announced the signing of a non-binding MOU with Taiwan-based Tex-Ray, a pioneer in performance fabric and smart clothing for modern active lifestyles. If a definitive agreement is entered into, Tex-Ray would facilitate the introduction of Applied DNA’s CertainT authentication platform to its established supply chains in service of large global brands.

On January 24, 2019, Applied DNA announced the signing of an MOU with Taiwan-based Sun Chemical. If a definitive agreement is entered into, Sun would serve as a reseller of the Company’s CertainT authentication platform to textile manufacturers in Asia. Taiwan is today the world’s largest functional fabric production base accounting for approximately 50% of the global output value of performance fabrics.1
On December 26, 2018, the Company closed on a $2.75 million public offering of common stock and warrants. Subsequent to end of the first fiscal quarter, Maxim Group exercised its overallotment option that resulted in additional gross proceeds of approximately $250 thousand to Applied DNA.
On December 10, 2018, Applied DNA signed a joint development agreement with Everledger to develop and market a CertainT-enhanced, blockchain-based platform for provenance verification. The two companies believe this joint solution platform to be at the forefront of linking immutable digital transactions with synthetic molecular authentication to tightly track movement and chain of custody of forensically-identified goods across complex ecosystems.
On October 4, 2018, the Company announced the appointment of Wayne Buchen as Vice President of Strategic Sales to lead the Company’s global textile Strategic Sales efforts. With over 20 years of sales, sourcing and operations experience with established international brands, Mr. Buchen leads the development and execution of sales strategies to expand Applied DNA’s presence across global textile markets.
On September 18, 2018, Applied DNA announced the formation of LineaRx, whose purpose is to commercialize Applied DNA’s extensive experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction in the field of biotherapeutics, specifically gene and cellular therapies as well as vaccines. Management subsequently held an analyst day via webinar to address the potentially critical role the LineaRx platform can have in the future of gene therapy, vaccines and adoptive cell therapies.
1 View Source

Fiscal First Quarter 2019 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal first quarter-end 2019 results on Thursday, February 7, 2019 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

Participant Toll Free:1-844-887-9402
Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call
Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through February 9, 2018):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10127851
Webcast replay: View Source
For those investors unable to attend the live call, a copy of the presentation is expected to be posted by end of business on February 8, 2019 and available under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.