On Octpber 29, 2018 CStone Pharmaceuticals (CStone) reported the initiation in China of a Phase I clinical trial for CS3006, a small-molecule MEK1/2 inhibitor (Press release, CStone Pharmaceauticals, OCT 29, 2018, View Source [SID1234530446]). A first patient has been successfully enrolled and dosed at the 307th Hospital of the Chinese People’s Liberation Army in Beijing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"CS3006 is a highly selective mitogen-activated protein kinase (MEK) inhibitor developed by CStone", commented CStone’s chairman and Chief Executive Officer Dr. Frank Jiang. "We are very optimistic that current data for CS3006 compares favorably with other MEK inhibitors on the market currently. In addition, CS3006 is viewed as having great potential as part of combination therapy with CStone’s other pipeline candidates. We will continue to work to explore the value of CS3006 to provide effective new treatment options for cancer patients."

Dr. Jason Yang, CStone’s Chief Medical Officer, noted: "We completed patient enrollment in a first-in-human study for CS3006 initiated in Australia during the first-half of this year, a study that is progressing smoothly. This China Phase I bridging trial will further assess CS3006’s safety and preliminary efficacy in Chinese patients with solid tumors, and provide a foundation for further development. Thanks to the support of all parties involved, we have been surprised by the progress of CS3006 in China and will continue to push forward to insure CS3006 can benefit Chinese patients as soon as possible."

The Phase I study will be led by Dr. Xu Jianming of the 307th Hospital of the Chinese People’s Liberation Army, who said: "We are pleased to enroll the first patient in this study. We hope that this MEK inhibitor could provide patients a viable new treatment option either as a monotherapy or in combination with other immunotherapy drugs. We look forward to working together with CStone in assessing the safety and efficacy of CS3006 in patients with late-stage tumors."

About the MEK pathway

The RAS-RAF-MEK-ERK signal transduction pathway is among the most fundamental intracellular signaling pathways found in the majority of cells and is responsible for regulating key cellular activities such as cell growth, proliferation, survival, and apoptosis. MEK1 and MEK2 are serine/threonine protein kinases that act downstream of RAS and RAF to activate ERK. The inhibition of MEK can affect tumor cell survival, proliferation, and differentiation. Currently, three MEK inhibitors have been approved and marketed globally: Novartis’s MEKINIST (trametinib), Roche’s COTELLIC (cobimetinib) and Array’s Mektovi (binimetinib).

On October 29, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Dan Shine, senior vice president and president, Analytical Instruments, will present at the Baird 2018 Global Industrial Conference on Wednesday, November 7, 2018, at 12:30 p.m. (CST) at the Four Seasons Hotel, Chicago, Ill (Press release, Thermo Fisher Scientific, OCT 29, 2018, View Source [SID1234530300]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

You can access the live webcast of the presentation in the Investors section of our website, www.thermofisher.com.

On October 29, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that it will release third quarter 2018 financial results after the market closes on Monday, November 5, 2018 (Press release, Xencor, OCT 29, 2018, View Source [SID1234530286]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers, and referencing conference ID number 5577136. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 90 days

On October 29, 2018 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 the FDA has allowed the Investigational New Drug (IND) application for Athenex’s oral version of Eribulin currently named Eribulin ORA (Press release, Athenex, OCT 29, 2018, View Source;p=RssLanding&cat=news&id=2373833 [SID1234530318]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This FDA action allows Athenex to commence its clinical trial program, currently planned for first half of 2019. Eribulin, an effective treatment for metastatic breast cancer and liposarcoma, is currently limited to intravenous administration. Utilizing Athenex’s proprietary Orascovery platform with Eribulin, we were able to demonstrate that good oral absorption of Eribulin is possible, based on preclinical studies. In addition, the Eribulin active pharmaceutical ingredient (API) has been developed internally using a novel synthetic approach. We believe these developments demonstrate the broad utility of the Orascovery platform and commitment of Athenex to becoming a major global oncology biopharmaceutical company.

Dr. Michael Smolinski, Athenex’s Head of Preclinical Research, commented, "Athenex is delighted that the FDA has allowed the IND of Eribulin ORA. The demonstration of a favorable pharmacokinetic profile, with lowered peak plasma concentration and longer duration of the drug within the desired plasma concentration range, provides the potential for a better efficacy and an improved safety profile for Eribulin, similar to what we have observed with Oraxol (oral form of paclitaxel) and others. We have also developed a novel and efficient synthetic process for Eribulin with an excellent purity profile. This is the eighth US IND allowance that Athenex has obtained, reflecting the passion and dedication of the company to bringing new therapies to cancer patients."

Eribulin is an anticancer drug marketed by Eisai Company under the trade name Halaven. It is used to treat certain patients with breast cancer and liposarcoma. Eribulin is a synthetic derivative of the natural product Halichondrin B. The potent anticancer effects of this agent come primarily from its unique means of targeting microtubule dynamics, a process critical to cell proliferation.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, stated, "Eribulin is approved for the treatment of metastatic breast cancer patients who have received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline- and taxane-based chemotherapies. It is important to note that Eribulin is active in paclitaxel resistant tumors. This profile is expected to create a number of synergistic opportunities with the other drug candidates in our Orascovery clinical pipeline. We look forward to initiating the Phase I clinical studies soon."

The lead compound in Athenex’s Orascovery program, Oraxol, is currently in a pivotal Phase III study. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On October 26, 2018 Helix BioPharma Corp. (TSX, FSE: "HBP"), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported its financial results for the year ended July 31, 2018 (Press release, Helix BioPharma, OCT 26, 2018, View Source content/uploads/2018/10/20181026-HBP-Press-Release-Announces-Fiscal-2018-Results-FINAL.pdf [SID1234530410]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FINANCIAL REVIEW
The Company recorded a net loss and total comprehensive loss of $8,625,000 and $10,059,000 (a loss per common
share of $0.09 and $0.11) for the fiscal years ended July 31, 2018 and 2017 respectively.

Research and development
Research and development expenses totalled $6,084,000 and $6,524,000, respectively for the twelve-month periods ended July 31, 2018 and 2017.

L-DOS47 research and development expenses for fiscal 2018 totalled $4,893,000 (2017 – $5,496,000). L-DOS47
research and development expenditures relate primarily to the Company’s LDOS002 European Phase I/II clinical
study in Poland, LDOS001 Phase I clinical study in the U.S., and preliminary expenditures related to the Company’s
LDOS003 Phase II clinical study in

clinical study report. In addition, given the limited cash resources, the LDOS003 clinical trial which was previously
planned to commence enrolment in early 2018 had not moved forward though the Company is still committed to
advance the program. The Company continues to be committed to the LDOS001 study and has re-allocated
resources to improve patient enrollment. An amendment to the LDOS001 study protocol allowed the Company to
advance enrollment from Cohort two at the beginning of the 2018 fiscal year to where it was most recently announced that the Company commenced enrolment in the final two cohorts of the study which is now enrolling patients in Cohort six. In addition, the Company has begun early development of a Phase I/II study, L-DOS47 given in combination with doxorubicin, for the treatment of metastatic pancreatic cancer. An initial draft study protocol was circulated in July 2018 and ongoing development continues.

V-DOS47 research and development expenses for fiscal 2018 totalled $457,000 (2017 – $372,000). The higher
expenditures in the current year mainly reflect the increase in staff and consultants as the Polish subsidiary ramped
up activities in the program. In fiscal 2016 the Company established a wholly-owned subsidiary in Poland and entered
into a grant funding agreement with the Polish National Centre for Research and Development ("PNCRD") for research and development expenditures associated with V-DOS47. The Company’s subsidiary received $475,000
and $335,000 in fiscal 2018 and 2017, respectively, from the PNCRD.

CAR-T research and development expenses for fiscal 2018 and 2017 totalled $318,000 (2017 – $259,000). During
the current fiscal year, the Company announced a collaboration agreement related to novel CAR-T therapeutics and
new antibody-based technologies for cell-based therapies.

Corporate research and development expenses were relatively flat for fiscal 2018 and 2017 and totalled $432,000
(2017 – $474,000). Trademark and patent related expenses for fiscal 2018 and 2017 totalled $440,000 (2017 – $361,000). The Company continues to ensure it works to adequately protect its intellectual property.

Operating, general and administration
Operating, general and administration expenses totalled $2,462,000 and $3,738,000, respectively for the fiscal years
ended July 31, 2018 and 2016. The decrease in operating, general and administration expenses reflects the
Company’s cost cutting initiatives. The Company eliminated the employment/contractual arrangement with its then
CEO, who was also a director of the Company, and also let go if it’s controller as part of a headcount reduction plan.
Aggressive steps were also taken to reduce unnecessary expenditures such as travel and conferences. In addition,
various third-party contracts were also eliminated. During the fiscal year the Company hired Deloitte as strategic
advisor to explore partnering and licensing opportunities. Cost reductions in Canada were offset by operating, general and administrative expenditure increases incurred at the Company’s Polish subsidiary.

LIQUIDITY AND CAPITAL RESOURCES
As at July 31, 2018 the Company had a working capital deficiency of $1,901,000 (2017 – $504,000), shareholders’
deficiency of $1,527,000 (2017 – $17,000) and a deficit of $164,005,000 (2017 – $155,380,000).
The Company’s cash reserves of $366,000, as at July 31, 2018 are insufficient to meet anticipated cash needs for
working capital and capital expenditures through the next twelve months, nor are they sufficient to see the current
research and development initiatives through to completion. Subsequent to the Company’s fiscal year ending July
31, 2018, the Company closed two additional private placements for gross proceeds of $1,274,000. Though the
funds raised have assisted the Company in dealing with the working capital deficiency, additional funds are required
to advance the various clinical and preclinical programs and pay for the Company’s overhead costs. To the extent
that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers
securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its
development needs.

The Company’s consolidated financial statements, management’s discussion and analysis and annual information
form will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website
at www.helixbiopharma.com.