On August 12, 2019 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform technology called Tumor Treating Fields, reported that the China National Medical Products Administration (NMPA) granted Innovative Medical Device Designation for Optune, a Tumor Treating Fields delivery system that uses electric fields tuned to specific frequencies to disrupt cancer cell division, inhibiting tumor growth and causing affected cancer cells to die (Press release, Zai Laboratory, AUG 12, 2019, View Source [SID1234538601]).

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"We are excited that Optune has been granted the Innovative Device Designation as it will allow our team to accelerate dialogue with the NMPA and bring us closer to commercializing Optune in China," said Dr. Samantha Du, Founder and CEO of Zai Lab. "Our launch in Hong Kong has provided valuable insight into the impact that this device can have on patients with GBM, which is an area of high unmet clinical need in China and globally. We look forward to working closely with the NMPA as Optune advances through the regulatory process in China."

The Innovative Device Designation allows Zai Lab to take advantage of an expedited approval procedure for Optune that offers opportunities for pre-consultation with and input from the NMPA throughout the approval process. Novocure granted Zai Lab an exclusive license for Tumor Treating Fields, including the brand name Optune, in Greater China in September 2018 and Zai Lab successfully launched the product in Hong Kong for the treatment of glioblastoma (GBM) late last year. Novocure markets Optune in the United States, European Union, Japan and certain other countries for the treatment of GBM and the NovoTTF-100L System, another Tumor Treating Fields delivery system, in the U.S. for the treatment of malignant pleural mesothelioma. Tumor Treating Fields is in late stage clinical development for four solid tumor indications including non-small cell lung cancer, brain metastases, pancreatic and ovarian cancers. Tumor Treating Fields was included and recommended with Level 1 evidence as a treatment for GBM in China’s Glioma Treatment Guideline published in 2018.

"We are committed to bringing Optune to as many patients who may benefit as possible," said Novocure’s Executive Chairman Bill Doyle. "Zai Lab has been an excellent partner as we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing Tumor Treating Fields therapy. We are pleased that together with our partners at Zai Lab we are one step closer to commercializing Optune in China."

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

On August 12, 2019 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing novel drug candidates in indications of high unmet medical need, reported financial results for the second quarter ended June 30, 2019 (Press release, Applied Therapeutics, AUG 12, 2019, View Source [SID1234538620]).

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"During the second quarter, we continued to execute on advancing our robust pipeline of novel drug candidates through the clinic," said Shoshana Shendelman, Founder, Chief Executive Officer and Chair of the Board of Applied Therapeutics. "We initiated our Phase 1/2 trial of AT-007 in Galactosemia in June and reported favorable Single Ascending Dose data from healthy volunteers last week. We look forward to advancing AT-007 through the next portion of the trial, which includes treatment of adults with Galactosemia. In addition, we are preparing for the dosing of the first patient in our registrational Phase 3 trial for our lead asset, AT-001, in Diabetic Cardiomyopathy (DbCM), which we expect to occur in the third quarter."

Recent Highlights

Reported Single Ascending Dose Data from Healthy Volunteer Portion of Phase 1/2 ACTION-Galactosemia Trial Evaluating AT-007. In August 2019, we announced the completion of the Single Ascending Dose (SAD) healthy volunteer portion of the Phase 1/2 study of AT-007 in Galactosemia. AT-007 was well tolerated, with no drug-related adverse events or dose-limiting toxicities reported. The study, referred to as ACTION-Galactosemia, was initiated in June 2019 and is designed to investigate the safety and pharmacokinetics (PK) of AT-007, a central nervous system (CNS) penetrant Aldose Reductase (AR) inhibitor in healthy volunteers, and biomarker effects in adult subjects with Galactosemia. Data from the adult Galactosemia patient portion of the trial is expected in the fourth quarter of 2019. We plan to employ recent FDA guidance permitting biomarker-based development in low prevalence, slowly progressing rare metabolic diseases, such as Galactosemia.

·Presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the American Diabetes Association (ADA) 79th Annual Scientific Sessions in San Francisco. In June 2019, we presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the ADA Annual Scientific Sessions. The data, presented as part of the Late Breaking session, demonstrated that AT-001 was well tolerated at all dose levels, and target engagement was confirmed by potent AR inhibition as evidenced by significant reductions in sorbitol, a pharmacodynamic biomarker of AR activity. AT-001 also improved selectivity and affinity for AR and resulted in potent AR inhibition.

·Received FDA Orphan Drug Designation for AT-007 in Galactosemia. In May 2019, we received orphan drug designation for AT-007 in Galactosemia. The designation allows Applied Therapeutics to qualify for a number of incentives, including: seven years of market exclusivity upon regulatory approval, if received; exemption from FDA application fees for Galactosemia; and tax credits for qualified clinical trials.

·Presented Phase 1/2 Data Highlighting Safety and Proof of Biological Activity for AT-001 in DbCM at The European Society for Cardiology (ESC) 6th World Congress in Athens, Greece. In May 2019, we presented two posters at ESC, the first of which was presented in the Late Breaking session and highlighted key data from a recently completed Phase 1/2 study in approximately 120 type 2 diabetic patients describing the safety, pharmacokinetics and proof of biological activity for AT-001 in DbCM. Supporting preclinical data from an animal model of DbCM was also presented, demonstrating that AT-001 prevents or reduces cardiac damage in a relevant disease model.

·Completed Initial Public Offering. In May 2019, we completed our IPO, generating approximately $34.6 million in net proceeds, after deducting underwriter discounts and commissions and offering expenses payable by us.

Financial Results

·Cash and cash equivalents totaled $41.1 million as of June 30, 2019, compared with $18.8 million at December 31, 2018.

·Research and development expenses for the three months ended June 30, 2019 were $4.3 million, compared to $1.9 million for the three months ended June 30, 2018. The increase of approximately $2.4 million was primarily related to costs associated with progressing our clinical trials, including an increase in clinical and pre-clinical expenses of $1.6 million and personnel expenses of $2.1 million due to the hiring of research and development personnel, including the Chief Medical Officer in August 2018. These increases are offset by a decrease in drug manufacturing and formulation expenses of $1.3 million.

·General and administrative expenses were $4.2 million for the three months ended June 30, 2019, compared to $0.4 million for the three months ended June 30, 2018. The increase of approximately $3.8 million was primarily related to personnel expenses of $2.2 million due to the increase in headcount, including the hiring of the interim Chief Financial Officer and the Controller, professional fees of $0.9 million due to increased legal and consulting fees, and other expenses of $0.7 million, primarily due to public relations efforts, travel expenses and recruiting efforts.

·Net loss for the second quarter of 2019 was $8.4 million, or $0.60 per basic and diluted common share, compared to a net loss of $3.2 million, or $0.58 per basic and diluted common share, for the second quarter of 2018.

On August 12, 2019 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic" or "Company"), a biopharmaceutical company focused on developing novel therapeutics to treat unmet needs in patients with liver, respiratory and kidney disease, primarily in rare or orphan diseases, reported financial results for its fiscal 2019 second quarter ended June 30th 2019 (Press release, ProMetic Life Sciences, AUG 12, 2019, https://resources.prometic.com/latest-content/prometic-reports-financial-results-for-second-quarter-2019 [SID1234538645]). All amounts are in thousands of Canadian dollars and adjusted to reflect the reverse share consolidation, except where otherwise noted.

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"During the second quarter, we were able to complete a series of financial transactions to stabilize and improve our financial situation at Prometic, and we will look to strengthen our balance sheet further in 2019 as our ongoing business development activities are brought to a conclusion," said Kenneth Galbraith, Prometic’s Chief Executive Officer. "We are now focused on progressing the development of our novel products, Ryplazim, PBI-4050 and PBI-4547 to address serious unmet patient needs in life threatening diseases. We look forward to sharing more about our progress in clinical development throughout 2019 and 2020."

Management Appointments

Effective September 1, 2019, Ms. Murielle Lortie, currently Vice President – Finance, will be promoted to Chief Financial Officer of the Company and Ms. Marie Iskra, currently Associate General Counsel, will be promoted to General Counsel for the Company. Mr. Patrick Sartore and Mr. Bruce Pritchard will continue to focus on their roles as Chief Operating Officer, North America and Chief Operating Officer, International, respectively.

"I am very pleased to welcome Murielle and Marie to the leadership team as I have been impressed by their contributions to the Company during my tenure as CEO, and look forward to their increased role in driving growth for Prometic in the years ahead. Their appointments will also allow Patrick and Bruce to increase their focus on the achievement of the key goals to drive shareholder value in both the near-term and long-term", said Mr. Galbraith.

Second Quarter Financial Results – Overview

Prometic’s cash position in the second quarter of 2019 substantially improved as a result of a series of related arrangements to restructure Prometic’s outstanding indebtedness, reduce its interest and certain other payment obligations, and raise sufficient cash to build a robust balance sheet to fund the next phase of Prometic’s development (collectively the "Refinancing Transactions"):

$114.4 million (US$87 million) aggregate gross proceeds were raised through a combination of a private placement offering of Common Shares led by Consonance Capital Management ("Consonance") and a concurrent equity rights offering ("Rights Offering") to shareholders of Prometic at a price of $15.21 per Common Share (the "Transaction Price");
Approximately $228.9 million (US$173 million) of the outstanding debt owned by Structured Alpha LP ("SALP") was converted into Common Shares at the Transaction Price, comprising all but $10 million of SALP’s outstanding debt;
The adjustment of the per warrant exercise price of certain outstanding Common Share purchase warrants of Prometic held by SALP to the Transaction Price (the "Warrant Repricing"); and
A share consolidation on the basis of one post-consolidation Common Share for every one thousand pre-consolidation Common Shares was completed on July 5, 2019 in anticipation of a filing for listing of the Company’s Common Shares on NASDAQ.
Current near-term priorities for the Company’s leadership team are as follows:

Completing the necessary manufacturing and related activities to allow for submission in H1-2020 to the FDA of an amendment to the Company’s BLA seeking regulatory approval for Ryplazim .
The filing and approval of an Investigational New Drug application ("IND") to enable the commencement of pivotal phase 3 clinical studies of PBI-4050 in patients with Alström Syndrome.
Continuing to work with external advisors, Lazard, on opportunities to partner or monetize assets and businesses outside of the Company’s small molecule therapeutics business.
Initiation of Phase 1 clinical studies for PBI-4547.
Completing the process to list the Company’s common shares for trading on NASDAQ.

2019 Second Quarter Results

Revenues

Total revenues for the quarter ended June 30, 2019 were $8.8 million compared to $20.2 million during the comparative period of 2018 which represents a decrease of $11.4 million.

Revenues from the sale of goods were $8.4 million during the quarter ended June 30, 2019 compared to $19.7 million during the corresponding period of 2018, representing a decrease of $11.3 million. The decrease is due to the decrease in sales of excess normal source plasma inventory and was partially offset by increases in sales from our Bioseparation products by $2.3 million.

Cost of sales and other production expenses

Cost of sales and other production expenses were $3.9 million during the quarter ended June 30, 2019 compared to $16.4 million for the corresponding period in 2018, representing a decrease of $12.5 million. The decrease in cost of sales and other production expenses, is mainly driven by changes in the volume of sales of goods.

Research and Development ("R&D")

R&D expenses were $24.2 million during the quarter ended June 30, 2019 compared to $24.0 million for the corresponding period in 2018, representing a slight increase of $0.2 million.

R&D expenses include the cost to manufacture plasma-derived therapeutics and small molecule therapeutics for use in clinical trial studies, to supply clinical trial patients until commercially approved product is available, and the cost for the development of our production processes of Ryplazim in preparation of filing an amended BLA to the FDA. The manufacturing and purchase cost of these therapeutics was $11.8 million during the quarter ended June 30, 2019 compared to $10.9 million during the quarter ended June 30, 2018.

Administration, Sales & Marketing

Administration, selling and marketing expenses were $18.6 million during the quarter ended June 30, 2019 compared to $6.9 million for the corresponding period in 2018, representing an increase of $11.6 million. This increase is mainly attributable to the $9.4 million increase in share-based payments expense due to significant changes in stock options and restricted stock units driven by the Refinancing Transactions.

Share-based payments expense

Share-based payments expense represents the expense recorded as a result of stock options and restricted stock units issued to employees and directors.

Share-based payments expense were $14.9 million during the quarter ended June 30, 2019 compared to $0.7 million during the corresponding period of 2018, representing an increase of $14.2 million.

In conjunction with the Refinancing Transactions, the Company made significant changes to its long-term equity incentive plans to ensure alignment with performance and building shareholder value, and attraction and retention of key employees to drive the Company’s future growth. The following important changes were made:

the cancellation of the outstanding options for employees in return for the issuance of new options;
the modification of the outstanding performance-based restricted share units ("RSU") into time-vesting RSU, and discontinuation of the RSU plan for any future grants; and
the issuance of the new stock options to employees and directors with vesting consistent with industry norms and tied to long-term increases in shareholder value.
Certain of these changes triggered an immediate or accelerated recognition of share-based compensation expense during the quarter ended June 30, 2019, causing a substantial increase in the non-cash share-based compensation expense during the quarter.

Finance Costs

Finance costs were $3.6 million for the quarter ended June 30, 2019 compared to $5.3 million during the corresponding period of 2018, representing a decrease of $1.8 million. The decrease is mainly due to lower level of debt in the quarter ended June 30, 2019 compared to the same period of 2018 due to the debt restructuring completed as of April 23, 2019.

The adoption of the new lease standard, IFRS 16, Leases ("IFRS 16"), at the beginning of 2019, under which lease liabilities are recognized for the discounted value of the future lease payments at initial adoption and with interest expense recognized over the term of each lease, is contributing to increasing finance costs in 2019. The new standard was adopted using the modified retrospective approach and as such, the 2018 figures are not restated. Previously, the embedded interest component in each lease payment was recognized as part of the lease expense included in the various functions presented in the statement of operations such as cost of sales and other production expenses, R&D and administration, selling and marketing. The interest expense over the lease liabilities was $1.8 million and $3.6 million for the quarter and the six months ended June 30, 2019, respectively.

Non-cash loss on extinguishment of liabilities

Loss on extinguishments of liabilities were $92.3 million for the quarter ended June 30, 2019 principally as a result of the Company concluding a debt restructuring agreement on April 23, 2019 with its major creditor, SALP. The debt was reduced to $10.0 million plus accrued interest due, in exchange for the issuance of 15,050,312 post-consolidation Common Shares. The difference between the adjustment to the carrying value of the loan of $141.5 million and the amount recorded for the shares issued of $228.9 million was recorded as a loss on extinguishment of a loan of $87.4 million. This amount represents the immediate recognition of the accreted interest that would have otherwise been recognized as finance costs over the years until the maturity of the long-term debt. Legal fees related to the debt restructuring and the value of the Warrant Repricing were also recognized as part of the loss on extinguishment of liabilities.

Net Loss

The Company incurred a net loss of $133.7 million during the quarter ended June 30, 2019 compared to a net loss of $33.1 million for the corresponding period of 2018, representing an increase in the net loss of $94.9 million. This is mainly driven by the impact of the loss on extinguishment of liabilities caused by the debt restructuring of $92.3 million that occurred during the second quarter and the increase in the share-based compensation expense of $14.2 million.

Subsequent Events

On July 2, 2019, In anticipation of filing a listing application for trading the Company’s Common Shares on NASDAQ, Prometic announced the consolidation of the Company’s issued and outstanding common shares on the basis of one (1) post-consolidation Common Share for every one thousand (1000) pre-consolidation Common Shares (the "Consolidation"). This consolidation was approved at the special meeting of the common shareholders of the Company held on June 19, 2019 and commenced trading on the TSX on a post-consolidation basis at the open of trading on July 5, 2019.

On August 12, 2019 LineaRx, Inc. ("LineaRx"), a majority-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") reported that, in a decision rendered on August 7, 2019, the Centers for Medicare and Medicaid Services (CMS) approved chimeric antigen receptor (CAR) T-cell therapies that fit the CMS criteria for Medicare beneficiaries nationwide (Press release, LineaRx, AUG 12, 2019, View Source [SID1234538602]). LineaRx believes its unique method of manufacturing DNA is well poised to benefit from the increasing demand for nucleic-acid dependent therapies, like CAR T, as biotechnology companies pursue their gene and cell therapies with reimbursement assured by the CMS decision.

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CAR T-based treatments involve extracting and genetically altering a patient’s T cells to attack a protein on the surface of cancer cells. The cells are then infused back into the patient. All approved CAR T and other redirected cell therapies are manufactured using DNA that is bacterially derived and then delivered to the patient’s T cells by a virus. Such plasmids-based treatments require about three weeks to grow and are acknowledged to have the potential for unintended side-effects. LineaRx offers a cleaner, potentially higher-performing alternative to plasmid DNAs with linear DNAs produced by PCR (Polymerase Chain Reaction) that are used to reprogram CAR T cells. Applications for redirected cells are broadly anticipated with more than 850 trials globally listed on clinicaltrials.gov.

"The oncology community has greeted CAR T cell therapy with extraordinary enthusiasm, but the use of these novel therapies to combat cancer has been constrained by pricing and reimbursement. With the CMS decision, redirected cell therapies are now a permanent part of the toolbox of modern medicine, and with LineaRx, we believe we have a more desirable manufacturing process than plasmids, that will enable biotech companies to accelerate their commercialization efforts," stated Dr. James Hayward, president and CEO of LineaRx. "With the LineaRx ability to provide massive ultrapure DNA with shorter lead times than plasmids, its manufacturing technology should enable gene therapy companies to shorten time-to-market for their therapies and in a much more cost-efficient manner. Patients will also benefit by a more rapid turnaround. Moreover, we believe that our recent acquisition of Vitatex, which just closed last week, facilitates our development of redirected cell therapies by enabling us to study the lymphocytes that we capture alongside the circulating tumor cells from the blood of cancer patients. We believe these studies will guide us toward optimal design of the engager that allows CAR T cells to recognize their host’s cancer at a molecular level."

Full text of CMS decision: Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

On August 12, 2019 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the second quarter 2019, and recent business highlights (Press release, Equillium, AUG 12, 2019, View Source [SID1234538621]).

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"Since our last quarterly update, we took significant steps forward in the clinical development of our lead therapeutic candidate, itolizumab, with the initiation of the Phase 1b EQUIP proof-of-concept trial for the treatment of uncontrolled asthma, and acceptance of our IND application by the FDA for the treatment of lupus nephritis," stated Daniel Bradbury, chairman and chief executive officer of Equillium. "With two clinical trials now up and running, and a third trial in lupus nephritis planned to commence later this year, we are well positioned to establish the broad clinical utility of itolizumab on our path toward helping improve the lives of patients with severe immuno-inflammatory disorders. We look forward to several important clinical milestones through the end of 2020."

Business Highlights:

Initiated the EQUIP Phase 1b proof-of-concept trial evaluating itolizumab for the treatment of uncontrolled moderate to severe asthma

IND application accepted by the FDA for a Phase 1b proof-of-concept trial of itolizumab for the treatment of lupus nephritis

Continued to advance the Phase 1b portion of the EQUATE trial evaluating itolizumab for the frontline treatment of acute graft-versus-host disease (aGVHD)

Expanded Scientific and Clinical Advisory Team with the appointments of Tom Daniel, M.D., Brian Kotzin, M.D. and Larry Steinman, M.D.

Upcoming Milestones:

Planned initiation of the EQUALISE trial – a Phase 1b proof-of-concept trial of itolizumab for the treatment of lupus nephritis during the second half of 2019

Data from the Phase 1b portion of the EQUATE aGVHD trial expected during the first quarter of 2020

Data from the EQUIP Phase 1b proof-of-concept trial of itolizumab for the treatment of uncontrolled moderate to severe asthma expected in the second half of 2020

Second Quarter 2019 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the three months ended June 30, 2019 were $4.3 million, compared with $0.5 million for the same period in 2018. The increase in R&D expenses was primarily driven by additional costs related to regulatory and clinical development activities associated with the EQUATE, EQUIP and EQUALISE clinical trials, increased headcount expenses, and preclinical research activities to support Equillium’s clinical development program.

General and administrative (G&A) expenses. Total G&A expenses for the three months ended June 30, 2019 were $2.2 million, compared with $0.6 million for the same period in 2018. The increase in G&A expenses was primarily driven by additional costs related to increased headcount expenses, costs related to being a public company and legal and professional fees.

Net loss. Net loss for the three months ended June 30, 2019 was $6.1 million, or $0.35 per common share (basic and diluted), compared with a net loss of approximately $1.8 million, or $0.16 per common share (basic and diluted), for the same period in 2018.

Cash and cash equivalents. As of June 30, 2019, Equillium reported total cash, cash equivalents and short-term investments of $56.9 million, compared to $65.9 million as of December 31, 2018.