Presentation of ONCOS-102 Melanoma Data at SITC Annual Meeting

On November 11, 2019 Targovax ASA (OSE: TRVX), reported that clinical data from its combination trial with ONCOS-102 and Keytruda in anti-PD1 refractory melanoma was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Targovax, NOV 11, 2019, View Source [SID1234550886]).

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Dr. Shoushtari, MD, Medical Oncologist, Memorial Sloan Kettering, presented results from part 1 of Targovax’s phase I trial in anti-PD1 refractory melanoma combining ONCOS-102 with Keytruda. Headline data were released in July, showing that three out of nine patients had significant reduction of tumor burden (33% overall response rate, ORR), including one patient with a complete response, which is rarely seen in this late-stage patient population Please see the full presentation here: SITC (Free SITC Whitepaper) presentation

Øystein Soug, CEO of Targovax, commented: "Although the number of patients is small, 33% ORR is very encouraging and confirms our hypothesis that ONCOS-102 can immune activate PD-1 refractory tumors to respond to re-challenge with Keytruda. We are very excited that these data are being recognized with an oral presentation at the SITC (Free SITC Whitepaper) Annual Meeting."

Part 2 of the trial is currently enrolling patients, where an extended ONCOS-102 dosing regimen is being assessed.

An extended presentation will be given by Dr. Shoushtari at an investor event in NYC later this week:

SOLEBURY TROUT KOL DAY

Date:

15 November 2019

Time and place

2 pm ET; NYC, US

Presenter:

Dr. Alexander Shoushtari, Principal Investigator, Memorial Sloan Kettering Cancer Center, NYC

Webcast:

View Source

For more information about the Solebury Trout KOL day or to RSVP, institutional investors and sell-side analysts may contact [email protected].

KOL biography:

Alexander N. Shoushtari, MD, Medical Oncologist, Memorial Sloan Kettering

Dr. Shoushtari is a renowned expert in melanoma, with a research focus on uveal and mucosal melanomas. He has been part of several immunotherapy trials at MSKCC and is the Principal Investigator on the ONCOS-102 phase I trial in CPI refractory advanced melanoma. Dr. Shoushtari is a member of the research team of Dr. Jedd Wolchok, MD, PhD, Chief, Melanoma and Immunotherapeutics Service at the Memorial Sloan Kettering Cancer Center.

Bausch Health Companies Announces Participation in Upcoming Investor Conferences

On November 11, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the Company will participate in three investor conferences (Press release, Valeant, NOV 11, 2019, View Source [SID1234550885]).

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Joseph C. Papa, chairman and chief executive officer, Sam Eldessouky, senior vice president and corporate controller, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Stifel 2019 Healthcare Conference in New York on Nov. 20, 2019 at 10:55 a.m. ET.

Joseph C. Papa, chairman and chief executive officer, and Sam Eldessouky, senior vice president and corporate controller, are scheduled to participate at the 31st Annual Piper Jaffray Healthcare Conference in New York on Dec. 3, 2019 at 10:30 a.m. ET.

Paul S. Herendeen, executive vice president and chief financial officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Evercore ISI HealthCONx Conference in Boston on Dec. 4, 2019 at 8:45 a.m. ET.

A live webcast and audio archive of the events will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

Neptune Reports Fiscal 2020 Second Quarter Results

On November 11, 2019 Neptune Wellness Solutions Inc. ("Neptune" or the "Corporation") (NASDAQ: NEPT) (TSX: NEPT), reported its financial and operating results for the three-month period ended September 30, 2019 (Press release, Neptune Technologies et Bioressources inc, NOV 11, 2019, View Source [SID1234550884]). All amounts are in thousands of Canadian dollars except specified otherwise.

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Second Quarter Financial and Corporate Highlights:

Total revenues for the three-month period ended September 30, 2019 amounted to $6,512, representing an increase of $2,151 or 49% over the first quarter ended June 30, 2019 and a decrease of $559 or 8% compared to $7,071 for the three-month period ended September 30, 2018.
Revenues from the Cannabis segment reached $1,220, an increase of $1,182 sequentially from the three-month period ended June 30, 2019. Neptune started the commercial operations of its Cannabis segment in March 2019 and hence had no revenues in the prior year period ended September 30, 2018.
Revenues from the Nutraceutical segment for the three-month period ended September 30, 2019 amounted to $5,149, representing an increase of 20% sequentially, over the first quarter ended June 30, 2019 and a decrease of $1,922 or 27% compared to $7,071 for the three-month period ended September 30, 2018. The decrease in revenues was attributable to timing of orders of our nutrition business.
Net loss for the three-month period ended September 30, 2019 amounted to $20,775 compared to $3,050 for the three-month period ended September 30, 2018, an increase of $17,725. The increase is mainly attributable to an increase in stock-based compensation expense, depreciation and amortization and to accretion expense on contingent consideration combined with a lower Adjusted EBITDA1.
Adjusted EBITDA1 decreased by $3,353 for the three-month period ended September 30, 2019 to ($4,581) compared to the three-month period ended September 30, 2018. The decrease in Adjusted EBITDA1 is mainly attributable to investments made in the cannabis segment to grow the workforce in anticipation of increased sales volume as well as an increase in salaries and benefits at the corporate level.
On July 24, 2019, Neptune completed the acquisition of the assets of SugarLeaf. Neptune paid an initial consideration for SugarLeaf of $23.7 million (US$18.1 million), a combination of $15.8 million (US$12 million) in cash and 7.9 million (US$6.1 million) or 1,587,301 in common shares.
On August 14, 2019, Neptune announced the creation of Neptune Ventures, a strategic investment arm and technology incubator which is expected to stimulate innovation and partnerships in the cannabis and wellness industries.
On August 22, 2019, Neptune announced the addition of two new members to its team to support the company’s rapid growth. Neptune appointed Stephen Lijoi, as Vice-President Operations and José Dominguez as Cannabis Sommelier and Formulation Specialist.
In August 2019, Neptune appointed Mr. Philippe Trudeau to its Board of Directors. Mr. Trudeau is a visionary leader with extensive experience in consumer goods. Mr. Trudeau spent 25 years at Trudeau Corporation, a consumer products company marketed in more than 70 countries, where he held many key positions including president from 2010 to 2018.
Subsequent to Quarter-end

On October 4, 2019, Neptune announced a new strategic partnership with American Media LLC ("American Media") which will provide US$12 million in advertising and creative services to Neptune to support the marketing and commercialization of Neptune’s consumer-facing brands in the U.S. Neptune will issue 3,000,000 warrants to AMI, each warrant allowing the holder to purchase one common share of Neptune at an exercise price of US$8.00 per share and with a 5-year expiration date.
On October 17, 2019, Neptune announced that it entered into an agreement to provide extraction services to a large U.S.-based farming services operation. Under the contract terms, Neptune will receive hemp biomass to be processed and transformed into crude oil extracts. The 2-year agreement could reach a total value in excess of US$20 million.
On October 17, 2019, the Corporation announced the appointment of Brett DuBose as Vice-President of Sales for the U.S. Region. Brett has more than 20 years of sales experience, most recently with Lonza Consumer Health and Nutrition where he was Associate Director Sales, for the Eastern U.S and Canada.
On November 11, 2019, Neptune announced that it has entered into a definitive agreement with International Flavors & Fragrances Inc. (NYSE: IFF) to co-develop hemp-derived CBD products for the mass retail and health & wellness markets. Under this strategic product development partnership, IFF will leverage its intellectual property (IP) for taste, scent, nutrition, and ingredients to provide essential oils and product development resources. Neptune will leverage its proprietary cold ethanol extraction processes and formulation IP to deliver high quality, full and broad-spectrum extracts for the development, manufacture and commercialization of hemp-derived products, infused with essential oils, for the cosmetics, personal care and home care markets. The initial launch will include a variety of topical products across the aromatherapy category, a market estimated at approximately $3 billion annually. Neptune will issue 2,000,000 warrants to IFF, each warrant allowing the holder to purchase one common share of Neptune at an exercise price of US $12.00 per share and with a 5-year expiration date.
"We have a strong opportunity in the consumer market, and in recent months I have been focused on developing our B2B and B2C strategy for the U.S. market. According to most estimates, the U.S. hemp-derived CBD market is expected to exceed US$20 billion at retail in the next five years. This market size is roughly three to four times larger than the expected size of the Canadian cannabis market and represents our largest opportunity today. The collaboration agreement with IFF and the American Media partnership will help raise the awareness of our CBD brand, Forest Remedies. We expect to introduce our first consumer products at retail locations and online with rollout commencing in the first half of CY2020," stated Michael Cammarata, CEO of Neptune.

"We achieved a significant milestone in mid October when we completed our Phase II capacity expansion. This additional capacity will alleviate our constraints in the near-term and help accelerate the company’s revenue growth in the cannabis segment. However, the start-up of our ethanol process has been longer than initially expected which has delayed the full ramp-up by one month to the end of December. With regards to our CO2 operations, we have been running seven days a week since the end of July and we are pleased with our yields and quality of extracts." Said Stephen Lijoi, VP Operations.

"I believe we have created a very solid foundation to grow our company with a well capitalized balance sheet. Moreover, we are at an inflection point in terms of profitability. The dynamics of the legal cannabis and hemp extraction markets remain favorable with a scarcity of biomass extraction capacity in both Canada and the U.S., which should lead to continued sustained demand for our extraction services. We expect our revenue growth to accelerate for the remainder of the FY2020 based on the strong demand witnessed for extraction services. Lastly, we have a comprehensive strategy based on geographic diversification, and a wide scope of value-added services, as well as unique and distinctive products," concluded Mr. Cammarata.

Financial Results

Total revenues reached $6,512 for the three-month ended September 30, 2019, down versus last year’s revenues of $7,071. The majority of the revenues during the quarter were generated in the Nutraceutical segment. The decline in total revenues was attributable to timing of orders of our nutrition business.

For the three-month ended September 30, 2019, Adjusted EBITDA1 was a loss of $4,581 compared with a loss of $1,228 last year. The increased Adjusted EBITDA1 loss is due to investments made in the cannabis segment to grow the workforce in anticipation of increased sales volume as well as an increase in salaries and benefits at the corporate level. The decrease can also be explained by an increase in litigation legal fees and additional SG&A coming from SugarLeaf.

Neptune reported a net loss of $20,775 for the three-month ended September 30, 2019, an increase compared to a net loss of $3,050 last year. The increase in net loss is mainly attributable to an increase in stock-based compensation expense, depreciation and amortization and accretion expense recognized on contingent consideration as well as for the same reasons as stated in the Adjusted EBITDA1 section above.

Cash and cash equivalents were $24,399 as of September 30, 2019. On November 6, 2019, Neptune closed a revolving line of credit with a large Canadian financial institution for an amount of $5 million to support the nutraceutical segment.

Management Update

This summer Neptune initiated a search process to hire a new CFO. This process is well underway and the Corporation’s new CFO is expected to be announced in the coming months. Following the departure of Mario Paradis, Claudie Lauzon has been appointed interim CFO of the Company. Ms. Lauzon is the Corporate Controller of Neptune and has been employed by the Corporation for 10 years.

Official Launch of the Forest Remedies Brand

Our CBD consumer brand, Forest Remedies, was acquired along with the purchase of SugarLeaf Labs. Initially, Forest Remedies was used to gain consumer insights on CBD finished product forms. Since its beginning in the fall of 2018, the brand has gained traction locally. The increasing demand for high quality hemp-derived products has led Neptune to recently rebrand Forest Remedies to appeal to a wider audience. Forest Remedies offers finished products such as tinctures, balms, massage oils, soft gels, and pet soothers. Additional products are currently in development. Forest Remedies products will continue to be available online (www.forestremedies.com) and could enter mass market retailers in calendar 2020. With innovation and a focus on quality, Neptune is confident in its ability to successfully grow the Forest Remedies brand. The company will deploy a marketing campaign and will be launching a new online platform in early calendar 2020.

Research and Development Initiatives

Neptune is undergoing and/or planning 10 research and clinical studies to further elucidate the benefits of its MaxSimil omega-3 licensed technology. Among the several initiatives underway is a clinical study that is a follow-up on a successful nonclinical study to determine if MaxSimil fish oil, when used as a carrier oil, can increase the absorption of cannabinoids in humans. In another study Neptune will try to establish if our proprietary formulation of MaxSimil fish oil and CBD can help with occasional anxiety from everyday life events. We also have an upcoming clinical study which will look at the use of our proprietary formulation of MaxSimil fish oil and CBD for workout recovery to determine if athletes will benefit from its use. This builds on the findings of our mitochondrial activity and inflammation resolution studies. We have increased our clinical activity because of the benefits we see in combining our omega-3 formulations with cannabinoids and have increased the size of our R&D team accordingly.

Outlook

"We continue to see strong demand for extraction services in Canada. We have provided extraction services to five clients in Canada and expect to continue to diversify our client base in the coming months. While the ramp-up of our phase II ethanol extraction is slower than originally anticipated, once running at full capacity by the end of December, this custom-built specialized equipment should provide Neptune with low operational costs," said Stephen Lijoi, VP Operations at Neptune.

The construction of our Phase IIIa is ongoing and is being adapted to our customers’ needs and changes in the Canadian Federal and Provincial regulatory requirements for Cannabis 2.0. This process is expected to be completed before fiscal year-end, subject to Health Canada approval. The expansion of our packaging capabilities is tracking as planned along with the installation of security measures for our warehouse to comply with Health Canada’s requirements. We expect to send a license amendment to Health Canada for the certification of those areas early in calendar 2020.

The next few months will be very active at Neptune. We have several projects ongoing in Canada such as obtaining our organic certification, applying for our sales license and further down the road, seeking our EU GMP certification. These future catalysts should help the company accelerate its revenue growth in Canada.

Our U.S. operations are scaling up as planned and our facility in North Carolina should reach a processing capacity of 1,500,000 kg of biomass annually by the end of December, as expected. The recent changes implemented by the USDA are expected to increase the cultivation of hemp in the US and could translate into increased demand for biomass extraction in the coming years. The recent client wins are an endorsement of our ability to provide superior extraction services. Our talent pool continues to grow with the addition of key personnel such as a VP Sales – U.S. Region and a Head – Quality Assurance both of which should help support additional growth.

Zimmer Biomet Holdings to Present at Piper Jaffray’s 31st Annual Healthcare Conference

On November 11, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that it will participate in the Piper Jaffray Annual Healthcare Conference at the Lotte New York Palace in New York City (Press release, Zimmer Holdings, NOV 11, 2019, View Source [SID1234550883]). Bryan Hanson, President and Chief Executive Officer and Suky Upadhyay, Executive Vice President and Chief Financial Officer, will present for the company on Wednesday, December 4, 2019, at 11:30 a.m. Eastern Time.

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A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. The webcast will be archived for replay following the conference.

Compugen Reports Third Quarter 2019 Results

On November 11, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the third quarter ended September 30, 2019 (Press release, Compugen, NOV 11, 2019, View Source [SID1234550882]).

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"Our first presentation of clinical data last week at SITC (Free SITC Whitepaper) 2019 is an important milestone for Compugen," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We are encouraged by the initial signals of anti-tumor activity seen with COM701, a first-in-class PVRIG inhibitor, in the monotherapy dose escalation arm of the study treating a very challenging patient population. We believe these results lay a promising foundation for our ongoing and future studies and that our biomarker-driven strategy which focuses on indications we prioritized as most relevant to the PVRIG pathway has the potential to maximize the clinical impact of COM701. We look forward to testing our clinical hypotheses as we advance COM701 to the next stages of our Phase 1 study."

Dr. Cohen-Dayag continued, "In addition to our progress with COM701, we have advanced COM902, our anti-TIGIT antibody, closer to the clinic with the IND clearance received from the FDA. Initiating clinical trials with our second internally developed asset next year will be another important milestone, and we are particularly enthusiastic given the COM902 preclinical data that were also presented at SITC (Free SITC Whitepaper) last week, which further demonstrated that together with a PVRIG inhibitor these two complementary assets have the potential to synergistically address a biologically meaningful axis and possibly improve patient outcomes. Including the Bayer collaboration program targeting ILDR2, COM902 marks the third program to be evaluated in the clinic addressing new drug targets we discovered. We are proud of this remarkable achievement and remain committed to advancing our computationally discovered programs to possibly expand cancer immunotherapy treatment options for patients unresponsive or refractory to existing therapies."

Recent Corporate Highlights

Presented preliminary clinical findings from the ongoing Phase 1 trial of COM701 in patients with advanced solid tumors at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019)
COM701 was well-tolerated with no dose-limiting toxicities observed.
Initial signals of anti-tumor activity were observed in the heavily pretreated, all comers patient population enrolled in the study.
Presented trial-in-progress data at SITC (Free SITC Whitepaper) 2019 from the Phase 1 study evaluating COM701 as a monotherapy and in combination with Opdivo (nivolumab)
No dose-limiting toxicities were observed through the third dose level of COM701 with Opdivo.
Enrollment for the eighth dose level of COM701 monotherapy as well as the fourth dose level of COM701 with Opdivo are ongoing at IV Q4 weeks schedule.
Announced Investigational New Drug (IND) application clearance by the U.S. Food and Drug Administration (FDA) for COM902. A Phase 1 trial in patients with advanced malignancies is expected to begin in early 2020.
Presented new preclinical data on COM902 at SITC (Free SITC Whitepaper) 2019, supporting its potential role as a cancer immunotherapy treatment in combination with COM701 and PD-1 inhibitors.
Granted EPO Patent No. EP3347379 by The European Patent Office, which covers the composition of matter and use of COM902.
Granted U.S. Patent No. 10,351,625 by the U.S. Patent and Trademark Office, which covers the method of use of COM701 in combination with any anti-PD-1 antibody.
Financial Results

R&D expenses for the third quarter ended September 30, 2019, were $4.3 million, compared with $7.8 million for the comparable period in 2018. The decrease in R&D expenses was primarily due to the decrease in preclinical activities related to COM902, most of which were completed in 2018, and the cost reduction measures announced by the Company in the first quarter of 2019.

Net loss for the third quarter of 2019 was $6.5 million, or $0.1 per basic and diluted share, compared with a net loss of $3.1 million, or $0.05 per basic and diluted share, in the comparable period of 2018.

As of September 30, 2019, cash, cash equivalents, short-term bank deposits and restricted cash totaled $47.6 million, compared with $45.7 million as of December 31, 2018. The Company has no debt.

Conference Call and Webcast Information

The Company will hold a conference call today, November 11, 2019, at 8:30 am ET to review its third quarter 2019 results and SITC (Free SITC Whitepaper) poster presentations. To access the conference call by telephone, please dial 1-888-668-9141 from the United States, or +972-3-918-0609 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.