LIDDS licensee Jiangxi Puheng Pharma prepares for phase III trial in China

On November 7, 2019 LIDDS AB (publ) Jiangxi Puheng Pharma reported that it has after reviewing the preliminary results in LPC-004 decided to move ahead and has initiated discussions with Chinese medical authority, CFDA (Press release, Lidds, NOV 7, 2019, View Source [SID1234555902]). The phase III study protocol will be developed in close collaboration with LIDDS.

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LIDDS signed in 2018 an exclusive license agreement for Liproca Depot for Mainland China with Jiangxi Puheng Pharma, a company focusing on oncology and immuno-oncology. Liproca Depot, is an injectable cancer drug candidate for local treatment of prostate cancer. LIDDS is with Liproca Depot targeting patients under Active Surveillance with intermediate risk of progression, a patient group that are not getting surgery or radiation.

Jiangxi Puheng Pharma is a Chinese pharmaceutical company specializing in global collaborations and in-licensing. LIDDS received a signing fee exceeding USD 1 million in 2018 which will be followed by milestone payments and royalty on sales as long as NanoZolid patents are valid, currently until 2037. The phase III clinical trial will be conducted in urology clinics in China and will be fully financed by the Jiangxi Puheng Pharma. LIDDS and Jiangxi Puheng will work closely together to optimize time to market for launching Liproca Depot in China.

The prostate cancer market is growing in China with around 500 000 patients being diagnosed annually. Puheng expects that the sales of Liproca Depot will reach yearly sales of 50 000 to 70 000 treatments five years after launch.

Jiangxi Puheng views NanoZolid technology and specifically the Liproca Depot product as a very promising treatment for prostate cancer.

We are very pleased to receive the positive Phase IIb results and we have already started preparations for conducting the Liproca Depot clinical trial in China. We hope to extend the partnership with LIDDS and get other products based on the NanoZolid technology into our pipeline, says Mr. Dai Dai, CEO of Jiangxi Puheng.
Liproca Depot will benefit prostate cancer patients both in terms of efficacy and maintained quality of life. Prostate cancer is a fast-growing cancer disease in China, why research and development in this field is of great importance. We are pleased that Jiangxi Puheng already has decided to progress with the phase III trial in China, says Monica Wallter, CEO, LIDDS.
Jiangxi Puheng has its own regulatory and clinical departments and a highly recognized marketing and sales organization. Being deeply connected with the Chinese regulatory authorities and key clinical opinion leaders, their sales network covers 1,130 large scale public hospitals and an additional 4,592 hospitals in China. The sales team has launched four different drug products with an annual revenue of more than RMB 1.5 billion each and three drug products with revenues of RMB 1 billion respectively.

IntelGenx Reports Third Quarter 2019 Financial Results

On November 7, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the third quarter ended September 30, 2019 (Press release, IntelGenx, NOV 7, 2019, View Source [SID1234550612]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2019 Third Quarter Financial Summary:

Revenue was $61,000, compared to $700,000 in the third quarter of 2018
Adjusted EBITDA was ($2.3 million), unchanged from Q3-2018
Cash and short-term investments totaled $4.3 million as at September 30, 2019 compared to $2.2 million as at September 30, 2018
Recent Developments:

Received approval for prototype cannabis-infused VersaFilm product from co-development partner, Tilray (NASDAQ:TLRY), and initiated manufacturing scale-up work
Announced that its 505(b)(2) New Drug Application ("NDA") for RIZAPORT VersaFilm for the treatment of acute migraines was accepted for review by the U.S. Food and Drug Administration ("FDA") and that the FDA assigned a March 26, 2020, Prescription Drug User Fee Act ("PDUFA") goal date for completion of the review
Received a positive Data Safety Monitoring Board recommendation that the Company’s Montelukast VersaFilm Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease continue
Presented an overview of the Company’s business at the H.C. Wainwright 21st Annual Global Investment Conference
"In many respects, we are now just nearing the starting line with the anticipated commercialization of our two lead VersaFilm products," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "The initiation of scale-up work for the cannabis-infused VersaFilm product we are co-developing with our worldwide partner, Tilray, and receipt of a PDUFA goal date for completion of the FDA’s review of the RIZAPORT NDA, mark important milestones. We are looking forward to unveiling details about our cannabis-infused oral film as we approach product launch, and as always, to updating our stakeholders as we continue to make progress toward bringing our VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended September 30, 2019 amounted to $61,000, compared to $700,000 for the three-month period ended September 30, 2018. The decrease is mainly attributable to a $639,000 decrease in Research and Development ("R&D") revenues.

Operating costs and expenses were $2.6 million for the third quarter of 2019, versus $3.3 million for the corresponding three-month period of 2018. The decrease for the three-month period ended September 30, 2019 is mainly attributable to a $610,000 decrease in R&D expenses and a $153,000 decrease in Selling, General and Administrative expenses.

For the third quarter of 2019, the Company had an operating loss of $2.5 million, compared to an operating loss of $2.6 million for the comparable period of 2018.

Net comprehensive loss for the three-month period ended September 30, 2019 was $2.9 million, or $0.03 on a basic and diluted per share basis, compared to $3.0 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.

As of September 30, 2019, the Company’s cash and short-term investments totalled $4.3 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 third quarter financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5068946. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

Exicure Reports Third Quarter 2019 Financial Results and Recent Developments

On November 7, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported financial results for the third quarter ended September 30, 2019 and provided an update on corporate progress (Press release, Exicure, NOV 7, 2019, View Source [SID1234550657]).

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"Throughout the third quarter we have continued to execute against the strategic goals we set early in the year," said Dr. David Giljohann, Exicure’s chief executive officer. "Our immuno-oncology clinical trial is progressing as anticipated, while we continue to lay the groundwork for expanding our SNA platform in neurology. This scientific progress has been matched with expanded financial resources arising from our recent $63.3 million public offering and Nasdaq listing. In the coming quarters we look forward to building our organization to enhance our strategic execution," concluded Dr. Giljohann.

Third Quarter Corporate Progress and Recent Developments

AST-008 Phase 1b/2 clinical trial on track
As of November 1, 2019, we have dosed 13 patients in the first four cohorts of the Phase 1b stage of the clinical trial;
No treatment related adverse events or dose-limiting toxicity was observed;
Expect to disclose preliminary results from the Phase 1b in December of 2019.
Presented Positive Biomarker Results from Clinical Trial of XCUR17
Presentation at Oligonucleotide Therapeutics Society highlighted work by Dr. James Krueger at The Rockefeller University, in collaboration with Exicure, which examined the effects of XCUR17 on skin biopsies collected from patients in the Phase 1 trial;
Clinical findings in the Phase 1 trial matched reductions in keratin 16 protein and epidermal thickness observed in the patient biopsies;
Clinical findings were also shown to be correlated with downstream psoriasis-related inflammation markers including reductions in beta defensin 4A, interleukin 19, and interleukin 36A versus psoriatic skin at baseline.
Enhanced Financial Resources
Closed oversubscribed underwritten public offering of 31,625,000 shares of common stock at $2.00 per share for gross proceeds of $63.3 million with net proceeds of approximately of $58.8 million;
Up-listed from the OTC to the Nasdaq Stock Market.
Third Quarter 2019 Financial Results and Financial Guidance

Cash Position: Cash and cash equivalents were $70.4 million as of September 30, 2019 compared to $26.3 million as of December 31, 2018.

Research and Development (R&D) Expenses: Research and development expenses were $4.2 million for the quarter ended September 30, 2019, compared to $4.0 million for the quarter ended September 30, 2018. The increase was primarily due to higher employee-related expenses of $0.5 million and higher platform and discovery related expense of $0.1 million, partially offset by lower clinical development program expenses of $0.4 million.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.2 million for the quarter ended September 30, 2019, compared to $1.9 million for the quarter ended September 30, 2018. This increase is primarily due to costs related to the recruitment of two new board members and an open executive position, as well as incurred Nasdaq listing costs.

Net Loss: Net loss was $5.8 million for the quarter ended September 30, 2019, compared to net loss of $5.3 million for the quarter ended September 30, 2018. This increase was due to a $0.4 million reduction in Other income attributable to the (non-cash) fair value adjustment of our common stock warrant liability, the $0.3 million increase in G&A expenses described above, the $0.2 million increase in R&D expenses described above, partially offset by the addition of $0.5 million of revenue associated with the Dermelix transaction.

Cash Runway Guidance: We believe that, based on our current operating plans and estimates of expenses, as of the date of this press release, our existing cash and cash equivalents will be sufficient to meet our anticipated cash requirements in excess of twelve months.

AvantGen Enters a Strategic Collaboration Agreement to Develop Novel Anti-Cancer Therapeutic With Its NK Cell Engager Technology

On November 7, 2019 AvantGen, Inc., a biotechnology company with its array of technology platforms for antibody discovery, optimization, and novel NK cell engager generation, reported a strategic collaboration with an undisclosed biopharmaceutical company for the purpose of generating multiple novel bi-specific NK cell engaging therapeutic antibody product candidates (Press release, AvantGen, NOV 7, 2019, View Source [SID1234550673]).

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Under the terms of the agreement, AvantGen will be responsible for engineering bi-specific variants of specified molecules using its proprietary NK cell engager platform and the biopharmaceutical company’s antibodies against a novel disease target. The biopharmaceutical company will receive worldwide rights on an exclusive basis with respect to its proprietary target to develop and commercialize product candidates arising from the collaboration. AvantGen receives upfront payments and is eligible to receive milestone payments and royalties associated with the development and sale of any products derived from the collaboration.

"We are pleased to collaborate with a team of talented leaders in the field of immuno-oncology to generate a novel class of anti-cancer molecules with superior efficacy. Our cutting-edge NK cell engager platform is comprised of binders that are exquisitely specific for CD16a, an activating receptor expressed on NK cells, but do not cross-react with the highly homologous CD16b receptor which is expressed on neutrophils. These attributes are intended to greatly enhance desirable NK cell-mediated antibody dependent cellular cytotoxicity (ADCC) activity against cancer cells while minimizing the undesirable inhibitory effects of neutrophil-mediated ADCC functions," said Xiaomin Fan, Ph.D., founder and president of AvantGen. Dr. Fan continued, "Our platform is further differentiated by designing the NK cell engagers to activate NK cells only in the presence of cancer cells that are recognized by the tumor targeting moiety of the engager and in a manner that is not affected by high concentrations of human IgG. We welcome the opportunity to generate novel product candidates for our biopharmaceutical company partner under this collaboration, and look forward to entering similar arrangements with others on a cancer target-exclusive basis."

Triple-S Management Corporation Reports Third Quarter 2019 Results

On November 7, 2019 Triple-S Management Corporation (NYSE: GTS), a leading managed care company in Puerto Rico, reported its third quarter 2019 results (Press release, Triple-S Management, NOV 7, 2019, https://www.prnewswire.com/news-releases/triple-s-management-corporation-reports-third-quarter-2019-results-300953651.html [SID1234550706]).

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Quarterly Consolidated and Other Highlights

Net income of $13.9 million, or $0.58 per diluted share, versus net loss of $17.6 million, or $0.77 per share, in the prior-year period;
Adjusted net income of $12.1 million, or $0.51 per diluted share, versus adjusted net loss of $22.2 million, or $0.97 per share, in the prior-year period;
Operating revenues of $836.0 million, a 9.4% increase from the prior-year period, primarily reflecting higher Managed Care net premiums earned;
Consolidated loss ratio decreased 400 basis points to 83.4% versus the third quarter of 2018; this results from the unfavorable reserve development related to Hurricane Maria claims recognized by the Property and Casualty ("P&C") segment in the prior-year period;
Medical loss ratio ("MLR") increased 320 basis points to 86.4%;
Consolidated operating income was $19.0 million, compared to consolidated operating loss of $25.6 million in the prior-year period;
Expansion of share repurchase program to $25 million of availability, approved subsequent to quarter end.
"We had a solid third quarter, mainly driven by year-over-year growth in Medicare premiums and valuable bottom line contributions from our Life and P&C segments," said Roberto Garcia-Rodriguez, President and Chief Executive Officer. "We’ve continued strengthening our product offerings, improving the overall quality of service, and advancing our goal of creating a unique and optimal member experience."

"With respect to our P&C segment, our quarterly review of outstanding claims reaffirms our belief that our reserves remain adequate as of September 30, 2019," added Mr. Garcia-Rodriguez. "Given our confidence in the Company’s long-term strategy and our belief that its stock is undervalued, our Board has expanded our share repurchase program’s availability to $25 million. We anticipate commencing repurchases under the program during the week of November 11, 2019."

Selected Consolidated Quarterly Details

Consolidated net premiums earned were $815.0 million, up 9.8% from the prior-year period, primarily reflecting higher average premium rates within the Managed Care segment and an increase in membership in the Medicare and fully insured Commercial businesses. The increase was partially offset by lower Medicaid membership.
Consolidated claims incurred were $680.0 million, up 4.8% year-over-year. Consolidated loss ratio of 83.4% improved 400 basis points from the prior-year period, driven by the $52.3 million unfavorable prior period reserve development related to Hurricane Maria recognized by the P&C segment in the third quarter of 2018 that did not recur in the third quarter of 2019.
Consolidated operating expenses of $136.9 million decreased by $4.1 million, or 2.9%, from the prior-year period, primarily resulting from savings due to the suspension in 2019 of the HIP Fee, partially offset by higher personnel costs and commission expense. The Company’s operating expense ratio improved 220 basis points year-over-year to 16.7%, mostly driven by the increase in premiums during the third quarter of 2019.
Consolidated income tax expense was $5.9 million, compared to an income tax benefit of $3.4 million in the prior-year period. The income tax benefit in the third quarter of 2018 mainly reflects the loss before taxes in that period incurred by the P&C segment.
Selected Managed Care Segment Quarterly Details

Managed Care premiums earned were $746.5 million, up 9.7% year over year.
Medicare premiums earned of $367.1 million increased 29.4% from the prior-year period, largely due to an increase of approximately 52,000 member months and higher average premium rates, primarily reflecting a more competitive product offering and an increase in the average membership risk score.
Commercial premiums earned of $203.1 million increased 2.9% from the prior-year period, mainly reflecting higher fully insured enrollment during the quarter of approximately 25,000 member months and higher average premium rates, partially offset by the suspension of the HIP Fee pass-through in 2019.
Medicaid premiums earned decreased 11.8% from the prior-year period to $176.3 million, primarily reflecting a decrease in membership of approximately 126,000 member months, and the suspension of the HIP Fee pass-through in 2019. The decrease in membership follows the lower membership assigned to Triple-S by ASES when implementing the new Medicaid contract that became effective November 1, 2018.
Reported MLR of 86.4% increased 320 basis points from the prior-year period. This increase largely reflected the improved benefits offered in the Medicare Advantage 2019 product offering, the elimination of the HIP Fee pass-through, and the higher target MLR of the current Medicaid contract.
Update on P&C Segment Reserves related to Hurricane María

As of September 30, 2019:

Triple-S Propiedad, Inc. (TSP), the Company’s P&C subsidiary, has paid a cumulative amount of $692 million in claims related to Hurricane María. Estimated gross losses remain unchanged at $967 million.
TSP received 10 new claims during the third quarter, increasing the total number of claims to 17,746. It has closed approximately 96% of these claims. 709 claims remain open.
The Company evaluated any developments involving open claims, including new information that arose from lawsuits in which TSP has been served, as is customary when the Company conducts its quarterly review of TSP’s reserve levels. In addition, as described below, the Company conducted additional analysis of case reserves for claims in which lawsuits have been filed against TSP but not served.
TSP has been served with process in 218 lawsuits related to the 709 claims that remain open.
The Company conducted a search of the Puerto Rico court system’s electronic docket to identify lawsuits filed against TSP with respect to which TSP has not been served. This docket is a public record over which the Company has no control; furthermore, the Company is unable to verify its accuracy or completeness.
The docket search identified an additional 178 lawsuits filed against TSP that have not yet been served as required by law. All of them relate to claims previously registered with and evaluated by the Company.
The Company then performed additional analysis of case reserves for claims in which lawsuits have been filed against TSP but not served. Based on this analysis, as well as the customary review described above, the Company determined that there is no need to increase its estimate of gross losses nor adjust reserves related to Hurricane María.
As is the case for all claim liabilities, the gross losses related to Hurricane Maria are based on the Company’s best estimate of the ultimate expected cost of claims with the information currently on hand and are subject to change.
Results of Internal Investigation Related to Vital RFP

As previously disclosed in an 8-K filed with the Securities and Exchange Commission on July 30, 2019, the Company’s audit committee of independent directors engaged outside counsel to conduct a proactive investigation into the Company’s participation in the Vital RFP process. That investigation is substantially complete and has not uncovered any evidence of attempts by the Company to improperly influence the outcome of the Vital RFP process.

2019 Outlook

The Company is raising its full year 2019 guidance for adjusted net income per diluted share and reducing its guidance for operating expense ratio. It is maintaining its full year 2019 guidance for its consolidated operating income revenue, Managed Care premiums, consolidated claims incurred ratio and Managed Care MLR ratio. More specifically:

The Company continues to expect consolidated operating revenue for 2019 to be between $3.29 billion and $3.33 billion, which includes Managed Care premiums earned, net between $2.95 billion and $2.99 billion;
The Company continues to expect the consolidated claims incurred ratio for 2019 to be between 81.3% and 83.3%, and Managed Care MLR to be between 84.0% and 86.0%;
The Company is reducing consolidated operating ratio expectations for 2019 to be between 16.75% and 17.25%. The Company’s previous outlook was for consolidated operating expense ratio to be between 17.0% and 17.5%;
The Company continues to expect its effective tax rate to be between 29.0% and 33.0%; and
The Company raised adjusted net income per diluted share expectations for 2019 to be between $2.50 and $2.70, compared to its previous outlook for adjusted net income per diluted share between $2.40 and $2.60. Adjusted net income per diluted share guidance accounts for the August 2019 share dividend and does not account for any potential share repurchase activity during 2019. Estimated weighted average diluted share count for full year 2019 is expected to be 23.443 million shares.
Conference Call and Webcast

Management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss its financial results for the three months ended September 30, 2019. To participate, callers within the U.S. and Canada should dial 1-877-451-6152 and international callers should dial 1-201-389-0879 at least five minutes before the call.

To listen to the webcast, participants should visit the "Investor Relations" section of the Company’s website at www.triplesmanagement.com several minutes before the event is broadcast and follow the instructions provided to ensure they have the necessary audio application downloaded and installed. This program is provided at no charge to the user. An archived version of the call, also located on the "Investor Relations" section of Triple-S Management’s website, will be available about two hours after the call ends and for at least the following two weeks. This news release, along with other information relating to the call, will be available on the "Investor Relations" section of the website.

In addition, a replay will be available through November 21, 2019 by calling 1-844-512-2921 or 1-412-317-6671 and entering passcode 13695866. A replay will also be available at www.triplesmanagement.com for 30 days.