1stOncology™: Cancer Intelligence Service – Page 14364 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Helix BioPharma Corp. Announces Fiscal 2018 Year-end Results

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.

Andarix Pharmaceuticals to Present Lung Cancer Clinical Trial Results at the Society of Nuclear Medicine Meeting.

On October 26, 2018 ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for cancer reported that it will present the results of its latest clinical trial in lung cancer patients (Press release, Andarix Pharmaceuticals, OCT 26, 2018, View Source [SID1234530404]). The trial focused on the administration of Tozaride, the company’s lead candidate in neuroendocrine lung cancer patients. The abstract is entitled "Targeted Clinical Study with 188 Re P2045 in lung cancer expressing SSTR and well differentiated Neuroendocrine tumours," and will be presented at the SNMMI Northeast Regional Meeting 2018 in Newport, RI. October 26-27, 2018.

About Tozaride
Tozaride is a novel, best-in-class cancer therapy based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for both lung cancer (SCLC, NSCLC), and pancreatic cancer patients. Along with its companion diagnostic that helps identify patients most likely to respond – those with enough expression of the peptide’s target Tozaride could provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.

Amgen Announces Webcast Of 2018 Third Quarter Financial Results

On October 26, 2018 Amgen (NASDAQ:AMGN) reported that it will report its third quarter 2018 financial results on Tuesday, Oct. 30, 2018, after the close of the U.S. financial markets (Press release, Amgen, OCT 26, 2018, View Source;p=RssLanding&cat=news&id=2373775 [SID1234530308]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Court Issues Ruling in ZYTIGA® Patent Infringement Litigation

On October 26, 2018 Johnson & Johnson (NYSE: JNJ) reported that the United States District Court, District of New Jersey has issued a ruling invalidating all asserted claims of U.S. Patent No. 8,822,438 for ZYTIGA (abiraterone acetate) (Press release, Johnson & Johnson, OCT 26, 2018, View Source [SID1234530301]). The Court held that the patent claims would be infringed if the patent were valid. The patent infringement case was filed against several companies who have submitted Abbreviated New Drug Applications for 250 mg and/or 500 mg tablets.

Janssen strongly disagrees with the court’s ruling and will continue to defend the patent. We plan to appeal the decision. The Court has ordered that the status quo be maintained through October 30, 2018, and no generic launch shall occur before October 31, 2018 so that Janssen’s preliminary injunction motion to enjoin defendants from launching their generic products pending the appeal process can be decided. Janssen has filed a motion for rehearing with the U.S. Patent & Trademark Office (USPTO) in connection with the prior Inter Partes Review decisions related to the ‘438 patent.

Commercial launch of generic abiraterone acetate prior to the outcome of the appeals would be considered an at-risk launch. In Europe, ZYTIGA is protected by regulatory exclusivity through September 2022.

Janssen will continue to defend intellectual property rights relating to its innovative medicines. The company reaffirms its guidance provided on October 16, 2018 for operational sales growth of 5.5% to 6.0% and its adjusted earnings per share guidance of $8.13 – $8.18 for the full-year 2018.

IntelGenx Announces Exercise of Over-Allotment Option

On October 26, 2018 IntelGenx Technologies Corp. (TSXV:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported that in connection with its previously announced public offering (the "Offering") of units of the Company (the "Units") for aggregate gross proceeds of approximately US$12 million, Echelon Wealth Partners Inc. ("Echelon"), who acted as the Company’s exclusive placement agent in Canada in connection with the Offering, has exercised its option to place a further 903,610 Units pursuant to its over-allotment option (the "Over-Allotment Option"), resulting in additional gross proceeds to the Company of US$632,527 (Press release, IntelGenx, OCT 26, 2018, View Source [SID1234530268]).

Each Unit was issued at a price of US$0.70 and was comprised of one share of common stock (the "Offered Shares") and one half of one warrant (a "Warrant"), each whole Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of US$1.00 per share. The Warrants are exercisable immediately and will expire on October 22, 2021.

The Units were distributed under a final prospectus supplement to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement to the Canadian MJDS short-form base shelf dated October 18, 2018 filed by the Company in connection with the Offering.

Including the net proceeds from the exercise of the Over-Allotment Option, the Company expects the aggregate net proceeds of the Offering to be approximately US$11 million. The Company intends to use the net proceeds from the Offering for its 2a Montelukast Study, its Tadalafil 505(b)(2) submission to the U.S. Food and Drug Administration, and working capital