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]).

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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

Zepsyre® receives positive recommendation of the IDMC to continue with the Phase III trial in small-cell lung cancer (ATLANTIS)

On October 26, 2018 PharmaMar (MSE:PHM) has reported that the Phase III ATLANTIS trial has received from the Independent Data Monitoring Committee (IDMC) its recommendation that the trial, currently under way with Zepsyre (lurbinectedin, PM1183) in combination with doxorubicin in relapsed small-cell lung cancer patients should continue without any changes. This is the fourth IDMC safety data review that has been passed.

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The IDMC’s recommendation came after having reached the targeted number of 600 patients recruited.

The ATLANTIS trial compares Lurbinectedin plus doxorubicin to physician’s choice of either Topotecan or CAV (cyclophosphamide, adriamycin, vincristine) in a 1 to 1 randomization. The primary endpoint is overall survival, and based on the expected number of events, the results are expected around the end of 2019. The trial is 90% powered to deliver a hazard ratio of 0.75.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

Gamida Cell Announces Pricing of Initial Public Offering

On October 26, 2018 Gamida Cell Ltd., a leading cellular and immune therapeutics company, reported the pricing of its initial public offering of 6,250,000 ordinary shares at a public offering price of $8.00 per share for aggregate gross proceeds of $50.0 million (Press release, Gamida Cell, OCT 26, 2018, View Source [SID1234530214]). All of the shares in the offering are being offered by Gamida Cell. In addition, Gamida Cell granted the underwriters a 30-day option to purchase up to 937,500 additional ordinary shares at the initial offering price, less underwriting discounts and commissions. Gamida Cell’s ordinary shares are expected to begin trading on the Nasdaq Global Market on October 26, 2018, under the ticker symbol "GMDA." The offering is expected to close on or about October 30, 2018, subject to customary closing conditions.

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BMO Capital Markets and RBC Capital Markets are acting as joint book-running managers for this offering. Needham & Company and Oppenheimer & Co. are acting as co-lead managers for this offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on October 26, 2018. This offering will be made only by means of a prospectus. Copies of the final prospectus related to this offering may be obtained, when available, from: BMO Capital Markets, 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, Telephone: (800) 414-3627, Email: [email protected]; or RBC Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, Attention: Equity Syndicate Department, Telephone: (877) 822-4089, Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 any such state or jurisdiction

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.

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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.

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]).

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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.