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NKMax America Doses First Subject in Phase I Trial of SNK in Patients with Refractory Cancer

On August 13, 2019 NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that it has dosed the first subject in study SNK01-US01, a phase I clinical trial evaluating SNK, an ex vivo expanded autologous natural killer cell therapeutic, in patients with pathologically confirmed cancer refractory to conventional therapy (Press release, NKMax America, AUG 13, 2019, View Source [SID1234538704]).

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"We are pleased to initiate the first clinical study for SNK in the U.S. We are looking forward to establishing clinical data to support SNK’s potential as a safe and effective treatment for patients with refractory cancers," said Paul Song, MD, CMO and COO of NKMax America.

Stephen Chen, MBA, CTO of NKMax America commented, "Our ability to manufacture and deliver multiple doses of an NK cellular immunotherapy advances us towards our goal of providing a transformative cancer treatment to patients."

The company’s SNK product is an autologous therapy manufactured by harvesting a small number of a patient’s immune cells. After harvesting, NK cells are separated from the blood, purified, activated, and expanded in a cGMP facility. The activated NK cells, known as "SNK" are reinfused in the patient to fight against cancer.

The single arm, dose escalation study evaluates SNK administered intravenously once a week for five weeks at three different dosing levels. Nine subjects will be enrolled in the trial to investigate the safety and tolerability of SNK in adults with pathologically confirmed cancer refractory to conventional therapy.

The SNK study for refractory cancer is currently recruiting participants; for more information about the study, please visit View Source

AJMC® Study Determines Societal Impact of CAR T-Cell Treatment Delays

On August 13, 2019 Potentially curative cancer treatments, like chimeric antigen receptor (CAR) T-cell therapies, have revolutionized care for illnesses once thought to be a death sentence after relapse, such as pediatric acute lymphoblastic leukemia (pALL) and diffuse large B-cell lymphoma (DLBCL). While 2 approved treatments are available (tisagenlecleucel and axicabtagene ciloleucel), therapy initiation is often delayed due to payment processes—in fact, it was only this month that the Centers for Medicare and Medicaid Services released a long-awaited payment decision for Medicare beneficiaries with cancer in need of treatment with CAR T-cell therapy as well as a boost in hospital payment rates (Press release, The American Journal of Managed Care, AUG 13, 2019, View Source [SID1234538661]). In a new study in the current issue of The American Journal of Managed Care (AJMC), researchers defined the concept of the social value that these potentially curative therapies provide, but they caution that treatment delays caused by a lack of payment mechanisms and policies are limiting the potential impact of these treatments.

The issue stems from the fact that one-time CAR T-cell therapies, and even more costly upcoming gene therapies, are a challenge to existing US payment structures; their costs accrue up front, in contrast with other cancer drugs that are given—and paid for—over an extended time period.

Using an economic framework, researchers measured the social value of CAR T-cell therapy for relapsed or refractory pALL and DLBCL. Social value analyses were used to quantify a therapy’s economic value from a societal perspective and determine the share of that value accruing to the manufacturer and patients. Expanded patient access and greater health benefits increase social value, while higher production costs to develop the therapy reduce it.

Manufacturers have stronger incentives for innovation with a rising share of social value, but when treatment is delayed, social value is lost for both patients and manufacturers: Patients lose access to health improvements and manufacturer profit is reduced.

The study found that CAR T-cell therapy generated up to $6.5 billion and $34.8 billion of social value for patients with pALL and DLBCL, respectively. However, with one, two and six months of treatment delay, patients with pALL lost 9.8 percent, 36.2 percent and 67.3 percent of social value, respectively; patients with DLBCL lost 4.2 percent, 11.5 percent and 46 percent of social value, respectively.

The degree of CAR T-cell therapy’s value depends on timely patient access, but the authors note that it is not unusual for CAR T-cell therapy reimbursement approval to take up to 90 days, which may be longer than a waiting patient may live. Given other high-cost therapies in the pipeline, lessons learned from CAR T-cell therapies can help payers, policy makers and manufacturers, the authors say.

"Our research shows that CAR T offers potentially large value for patients and society, but only if patients can access it promptly," said lead study author Julia Thornton Snider, PhD. "It will be essential for all stakeholders to work together to ensure appropriate policies are in place to secure timely access for patients."

The study was funded by Novartis, maker of tisagenlecleucel.

Quanterix Announces Closing of Public Offering Including Exercise of Underwriters’ Option to Purchase Additional Shares

On August 13, 2019 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported the closing of its previously announced underwritten public offering of 2,732,673 shares of its common stock at a public offering price of $25.25 per share, including 356,435 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, Quanterix, AUG 13, 2019, View Source [SID1234538660]). Gross proceeds from the sale of the shares, before deducting underwriting discounts and commissions and offering expenses, were approximately $69.0 million.

J.P. Morgan Securities LLC and SVB Leerink LLC acted as joint book-running managers for the offering. Canaccord Genuity LLC acted as co-manager for the offering. Perella Weinberg Partners acted as independent capital markets advisor to Quanterix for the offering.

The public offering was made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC"). The final prospectus supplement and the accompanying prospectus relating to this offering has been filed with the SEC and is available on the SEC’s website located at www.sec.gov, copies of which can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; 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 will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Medpace Holdings, Inc. to Present at Baird Global Healthcare Conference

On August 13, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will present at the following investor conference in September (Press release, Medpace, AUG 13, 2019, View Source [SID1234538659]):

Baird Global Healthcare Conference
Location: New York, NY
Date: Wednesday, September 4, 2019
Presentation: 9:05 a.m. ET
Speakers: Dr. August Troendle, President & Chief Executive Officer, and Jesse Geiger, Chief Financial Officer & Chief Operating Officer, Laboratory Operations

A live webcast of each presentation will be accessible through the "Investors" section of the Company’s website at www.medpace.com and will be available for replay following each event.

Applied DNA Reports Fiscal Third Quarter 2019 Financial Results

On August 13, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), consolidated financial results for the fiscal 2019 third quarter ended June 30, 2019 (Press release, Applied DNA Sciences, AUG 13, 2019, View Source [SID1234538658]). "Our fiscal third quarter performance reflects our continuing abilities to monetize our molecular taggant technology and our diagnostic and therapeutic platforms while also realigning our cost structure and reorienting our sales and business development efforts to support new opportunities," said Dr. James A. Hayward, chairman, president and CEO of Applied DNA. "Revenues increased over 100% this quarter over the same period last fiscal year and increased 164% quarter over quarter, supplemented by the receipt of a $1 million cash payment under the terms of our exclusive licensing agreement with TheraCann International Benchmark Corporation (TheraCann)."

"After the close of the quarter we received a written delisting notice from Nasdaq regarding our non-compliance with the requirements for a $1.00 bid price and $35 million market value of listed securities. We are diligently working to comply with all applicable requirements for continued listing on Nasdaq and we intend to submit a plan to that effect to the NASDAQ Hearings Panel as part of the hearing process," continued Dr. Hayward. "As part of our plan, we secured a non-binding term sheet from TheraCann for the outstanding $4 million balance under our licensing agreement in the form of $4 million in convertible preferred stock as well as an incremental $1 million convertible note. We also raised $1.5 million through a convertible note offering, which increases our current convertible notes outstanding to approximately $3.7 million. If any portion of these notes were to convert into common stock, it would increase our equity as a further step towards facilitating Nasdaq compliance. We are engaged in Nasdaq’s appeal process, and I am pleased to report that we have secured a hearing for September 19, 2019 that allows us additional time to execute on the balance of our plan. However, we can not provide assurance that we will be successful in our NASDAQ appeal."

Concluded, Dr. Hayward, "As we projected last quarter, our growth is coming from cannabis, textiles and biotherapeutics. Looking ahead, we remain focused on growth supported by these business verticals. TheraCann’s ETCH BioTrace solution powered by our tagging platform is attracting the attention of large cannabis players. We will soon launch our CertainT brand into the cotton apparel market. Initial product from our recently completed tagging program for Egyptian cotton is being used to build demand among brands and manufacturers. Our LineaRx subsidiary is increasingly being viewed within the biotech industry as a cleaner, higher-performing alternative to plasmid DNA production that is converting to increased order-flow. We have a burgeoning pipeline and growing scientific and intellectual property assets following the recent acquisition by LineaRx of the assets and IP of Vitatex, Inc. that further broaden our platform’s applicability in the potentially high-reward cancer diagnostic and therapeutic spaces. Just last week we submitted to the NIH our application for a 3-year, approximately $4 million SBIR Phase IIb grant to be matched with funding being sought from commercial 3rd parties, that, if granted, will fund the full commercialization of the Vitatex platform for early detection of non-hematologic cancers."

Fiscal Third Quarter 2019 Financial Results:

Revenues increased 102% for the third quarter of fiscal 2019 to $2.1 million, compared with $1.0 million reported in the second quarter of fiscal 2018, and increased 164% from the $778 thousand reported in the second fiscal quarter ended March 31, 2019. The increase in revenues was due primarily to an increase in revenue from a licensing agreement in the cannabis industry of $1 million.
Total operating expenses decreased to $3.2 million for the second fiscal quarter of 2019, compared with $3.6 million in the prior fiscal year’s second quarter. This decrease is primarily attributable to approximately a $409 thousand decrease in payroll, due to a realignment of the sales force and reductions in overall headcount. This decrease in payroll was offset by an increase in legal and professional fees.
Net loss for the quarter ended June 30, 2019 was $1.5 million, or $0.04 per share, compared with a net loss of $2.9 million, or $0.10 per share, for the quarter ended June 30, 2018 and a net loss of $2.7 million, or $0.08 per share, for the quarter ended March 31, 2018.
Excluding non-cash expenses, Adjusted EBITDA was negative $1.2 million and a negative $2.5 million for the quarters ended June 30, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.
Nine-Month Financial Highlights:

Revenues for the first nine months of fiscal 2019 totaled $3.7 million, an increase of 37% from $2.7 million from the same period in the prior fiscal year. The increase in revenues was due to an increase in service revenues of $1.4 million, or 92%, offset by a decrease in product revenues of $344 thousand, or 28%. The increase in service revenue was attributable to an increase in revenue of $1 million from the licensing agreement in the cannabis industry, as well as increases of $140 thousand for a pre-commercial feasibility project under the cooperation agreement with TheraCann entered into during 2018, $51 thousand for the government contract award and $143 thousand from pre-commercial pilots within the textile industry.
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 $851 thousand during the first nine months of fiscal 2019. This amount was primarily comprised of the recognition of $766 thousand during the nine months periods ended June 30, 2019, under a $1.15 million cotton order shipped in June 2018, with extended payment terms. The total cumulative impact of the Update that was recorded to opening retained earnings in fiscal 2019 was approximately $494 thousand. See Cumulative Effect Adjustment and the Impact on Current Period Financial Statements of Adopting Topic 606 attached.
Operating expenses for the nine months ended June 30, 2019 increased by $486 thousand or 5% for the same period last fiscal year. The increase is primarily attributable to an increase in stock-based compensation and legal and professional fees, offset by a decrease in payroll of $659 thousand.
Net loss for the nine months ended June 30, 2019 was $7.4 million or $0.21 per share, compared with a net loss of $8.2 million or $0.28 per share for the nine months ended June 30, 2018.
Excluding non-cash expenses and interest, Adjusted EBITDA for the nine months ended June 30, 2019 was a negative $6.1 million as compared to a negative $7.6 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.
Fiscal Third Quarter 2019 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2019 results on Tuesday, August 13, 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 August 21, 2019):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10133063
Webcast replay: View Source
For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review 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.