On November 6, 2020 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, reported, at 4:30pm EST, will provide an update and overview of its clinical development pipeline / activities and its financial results for the third quarter ended September 30, 2020 (Press release, Ampio, NOV 6, 2020, View Source [SID1234570228]).

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Attending the webinar from Ampio will be, Mr. Michael Macaluso (President and CEO), Dr. David Bar-Or (Director and Founder), Ms. Laura Goldberg (Vice President) and Mr. Daniel Stokely (CFO). The key areas of focus will be as follows:

COVID-19 Platform / Pipeline Overview and Update

AP-014 (inhaled) and AP-016 (intravenous) clinical trial update
Possibility of obtaining an Emergency Use Authorization (EUA) from the FDA for inhaled Ampion
Discussion of the differences between Ampion vs. other therapeutic options for COVID-19
OAK Clinical Trial 2020 Timeline / Update

Ampio’s Osteoarthritis of the Knee (OAK) Phase III trial being conducted under a Special Protocol Assessment (SPA) with the FDA has been paused as a result of COVID-19
FDA released "FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic" in April 2020
FDA released "Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" in June 2020
Ampio harmonizes steps for OAK Phase III trial with the FDA guidance and submitted an SPA amendment to the FDA
Financial Update

As of September 30, 2020, Ampio had $9.4 million of cash and cash equivalents, as compared to cash and cash equivalents of $6.5 million as of December 31, 2019.

For the third quarter of 2020, research and development costs were $1.7 million, down 52% from $3.4 million for the same period in 2019. This decrease was primarily attributable to a decrease in clinical trial and sponsored research costs. Ampio expects clinical trial and sponsored research costs to increase during the fourth quarter of fiscal 2020 due to the AP-014 inhaled Ampion study.

Operations / manufacturing expenses increased $190,000 in the current quarter, when compared to the same period in 2019.

General and administrative costs decreased $98,000, or 5.6%, from $1.7 million for the same period in 2019.

Ampio reported a net loss for the third quarter of $3.4 million compared to a net loss of $7.2 million for the same period in 2019.

To access the webinar, please log in to View Source approximately 10 minutes prior to the start of the call. To ask a question, please dial in to 888-632-3385 (U.S.) or 785-424-1673 (International) and use the Participant Entry Code: 47668. Please note that you can also ask a question through the webinar platform.

A replay of this presentation will be available two hours after the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331 (International). Replay Passcode: 38512

On November 6, 2020 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for third quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 6, 2020, View Source [SID1234570223]).

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Recent Highlights and Upcoming Milestones

ZokinvyTM (lonafarnib) in Progeria and Progeroid Laminopathies

New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date November 20, 2020
Lonafarnib in Hepatitis Delta Virus (HDV)

Phase 3 D-LIVR study full enrollment expected in 2021
Peginterferon Lambda (Lambda) in HDV

Phase 2 LIFT (combo with lonafarnib) end-of-study data expected at AASLD 2020
Agreement with FDA and EMA on single, Phase 3 Lambda monotherapy study design
Peginterferon Lambda (Lambda) in COVID-19

Toronto General Hospital, University Health Network (N=60)
Mean baseline viral load: 6.7 log copies/mL
79% (Lambda) vs 38% (placebo) (p=0.013) clear virus by Day 7
> 6 log copies/mL correlates with the threshold for infectivity
Stanford University School of Medicine (N=120)
Mean baseline viral load: < 4 log copies/mL
Median time to cessation of viral shedding was 7 days in both groups
Results of both studies support Lambda activity in high baseline viral load patients
Lambda was well tolerated in both studies with few adverse events, which included minimal elevations of transaminases which self-resolved
Plan to meet with FDA to discuss data and next steps
Third Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of September 30, 2020 totaled $125.3 million.

The Company reported net loss of $15.7 million, or $0.52 per share, for third quarter 2020, as compared to $18.6 million, or $0.76 per share, for third quarter 2019.

Research and Development expenses were $9.8 million for third quarter 2020, as compared to $14.1 million for third quarter 2019. The decrease was primarily due to a decrease in clinical trial related expenses, including clinical trial material costs.

General and Administrative expenses were $5.0 million for third quarter 2020, as compared to $4.2 million for third quarter 2019. The increase was primarily due to an increase in outside consulting, advisory and accounting services and an increase in personnel-related expenses.

Total operating expenses include total non-cash expenses of $1.9 million for third quarter 2020, as compared to $1.8 million for the same period in 2019.

As of September 30, 2020, the Company had 31.9 million of common shares outstanding.

On November 6, 2020 Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported financial results for the third quarter ended September 30, 2020 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, NOV 6, 2020, View Source [SID1234570213]).

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"We achieved solid revenue growth in the third quarter, driven by continued steady utilization within our installed base of live Pheno instruments, an improving go-live cadence, and a large capital deal in the U.S.," commented Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. "While COVID-related delays in the go-live process have begun to moderate, our ability to contract new customers continues to be affected by the pandemic. However, we are beginning to see an improvement in customer engagement as our recent product approvals and upcoming product releases are beginning to stimulate new interest in Accelerate Diagnostics. I am very pleased with the efforts put forth by everyone on the Accelerate team during the quarter, as we have continued to make meaningful operational and financial progress in the face of an unprecedented macro-environment."

Third Quarter 2020 Highlights

Added 5 contracted instruments in the quarter and brought 22 instruments live in the U.S.
Ended the third quarter with 223 U.S. live revenue-generating instruments, with another 192 U.S. contracted Pheno instruments not yet live.
Net sales of $3.6 million, compared to $2.3 million in the third quarter of 2019, or 57% growth.
Gross margin was 36% for the quarter, compared to 51% in the third quarter of 2019. This decrease was the result of pandemic-related effects on manufacturing and dilution from the large capital deal in the quarter.
Selling, general, and administrative expenses for the quarter were $11.5 million, compared to $12.7 million in the third quarter of 2019. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.
Research and development (R&D) costs for the quarter were $5.0 million, compared to $6.1 million in the third quarter of 2019. This decrease was the result of increased efficiencies and lower external study spend.
Net loss was $18.8 million in the third quarter, or $0.33 per share, which included $4.7 million in non-cash stock-based compensation expense.
Net cash used in the quarter was $11.2 million, and the company ended the quarter with total cash, investments, and cash equivalents of $77.5 million.
Received 510k approval for a new suite of product enhancements to the Accelerate Pheno system, which improve performance and expand Pheno’s antimicrobial susceptibility testing (AST) menu for bloodstream infections.
Received FDA Emergency Use Authorization for the MS Fast fully automated chemiluminescence immunoassay analyzer and SARS-CoV-2 tests for the detection of IgG and IgM.
Year to Date 2020 Highlights

Net sales were $8.1 million year-to-date as compared to $5.8 million from the same period in the prior year, or 40% growth.
Gross margin was 41% year-to-date, compared to 50% from the same period in the prior year. This decrease was the result of pandemic related effects on supply chain and dilution from the large capital deal in the quarter.
Selling, general, and administrative expenses were $35.7 million year-to-date, compared to $38.3 million from the same period in the prior year. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.
Research and development (R&D) costs were $16.2 million year-to-date, compared to $19.1 million from the same period in the prior year. This decrease was the result of increased efficiencies and lower external study spend.
Net loss was $59.3 million year-to-date, or $1.07 per share, which included $12.3 million in non-cash stock-based compensation expense.
Net cash used was $31.0 million year-to-date, and the company ended the quarter with total cash, investments, and cash equivalents of $77.5 million.
Full financial results for the quarter ending September 30, 2020 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at View Source

Audio Webcast and Conference Call

The company will host a conference call at 4:30PM ET today to review its third quarter results. To listen to the 2020 third quarter financial results call by phone, dial +1.877.883.0383 and enter the conference ID: 0113821. International participants may dial +1.412.902.6506. Please dial in 10–15 minutes prior to the start of the conference. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using the replay code 10148610 until November 26, 2020.

This conference call will also be webcast and can be accessed from the "Investors" section of the company’s website at axdx.com/investors. A replay of the audio webcast will be available until November 7, 2020.

On November 6, 2020 The Board of Directors of Moberg Pharma AB (publ) (OMX: MOB) ("Moberg Pharma" or "the Company") reported that resolved to carry out a fully guaranteed issue of new ordinary shares and warrants ("Units") with preferential rights for existing shareholders (the "Rights Issue") of approximately SEK 150 million before transaction costs (Press release, Moberg Pharma, NOV 6, 2020, View Source [SID1234570205]). The Rights Issue requires the approval of an extraordinary general meeting (the "Extraordinary General Meeting"). The proceeds will be used for registration activities and clinical work for MOB-015. When the Rights Issue is completed, the Company intends to terminate the current convertible note agreement. By a separate press release, the Company has reported its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021.

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THIS PRESS RELEASE MAY NOT BE MADE PUBLIC, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA, THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH SUCH ACTIONS, WHOLLY OR IN PART, WOULD BE UNLAWFUL. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY SECURITIES IN MOBERG PHARMA AB (PUBL). SEE ALSO THE SECTION "IMPORTANT INFORMATION" BELOW IN THIS DOCUMENT.

Summary

The Rights Issue comprises Units and will provide Moberg Pharma with proceeds of approximately SEK 150 million before transaction costs. Each Unit consists of one (1) ordinary share and one (1) warrant free of charge. Two (2) warrants will entitle the holder to subscribe for one (1) ordinary share in the Company. The warrants are intended to be admitted to trading on Nasdaq Stockholm.
Provided that the Rights Issue is approved by the Extraordinary General Meeting on December 1, 2020, the record date for the Rights Issue will be December 3, 2020 and the subscription period will commence on December 7, 2020 up to and including December 21, 2020.
The final terms for the Rights Issue, including the subscription price, are expected to be announced not later than on November 27, 2020.
The notice of the Extraordinary General Meeting will be released separately.
The net proceeds from the Rights Issue are intended to be used primarily for the following activities:
Preparations for a marketing authorization application for MOB-015 in Europe:
Clinical work for MOB-015.
Other expenses for the Company’s operations.
The Rights Issue is comprised by approximately forty-two (42) percent subscription commitments and of approximately fifty-eight (58) percent issue guarantees. The Rights Issue is consequently fully guaranteed.
The distribution of the BUPI project is intended to be performed through a Lex Asea distribution of the shares in a subsidiary of the Company (name to be changed to OncoZenge AB). The Lex Asea distribution is planned to be performed after the completion of the Rights Issue, implying that the shares issued as a part of the Rights Issue will be entitled to the distribution of shares in the Lex Asea distribution.
"The financing we have secured gives us the opportunity to fully exploit MOB-015’s potential, both through the marketing authorization application in Europe and an additional clinical study for the US market. The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect," says Anna Ljung, CEO of Moberg Pharma.

Background and reason
Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinical development of products based on proven substances to commercialisation. The Company’s primary asset is MOB-015, where preparations are underway for registration in Europe based on two large phase 3 studies totaling more than 800 patients. MOB-015 is the next-generation nail fungus treatment targeting both OTC and prescription markets worldwide. The Company’s patented formulation technology facilitates the delivery of high concentrations of a proven antifungal substance (terbinafine) into and through the nail, enabling rapid elimination of the fungal infection.

The Company has secured contracts for commercialisation of MOB-015 with aggregate milestone payments of USD 120 million, in addition to compensation for delivered products, with strong partners in the EU, Japan, Canada and South Korea. MOB-015 has the potential to be the market-leading medication globally as the product has a world-leading ability to kill nail fungus (> 70 percent, compared to 30-50 percent for today’s topical treatments). The Company believes there is strong demand and an opportunity for rapid acceptance of a new, effective topical product as 100 million nail fungus patients in the EU and North America currently lack good treatment alternatives.

Since the primary endpoint was reached in the North American and European studies, both studies are expected to be used as a basis for product registration in Europe. The Company intends to submit a marketing authorization application in Europe during the second half of 2021. The Company expects, based on the processing time for previous applications, to receive approval within 18 months and that MOB-015 can be launched in Europe by the end of 2023. Moberg Pharma intends to discuss the next step for the US market in an advice meeting with the FDA, as an additional study is expected to be needed for registration in the US.

Use of issue proceeds
The net proceeds from the Rights Issue are intended to be used primarily for the following activities:

Preparations for the registration application for MOB-015 in Europe – 45 %.
Clinical work for MOB-015 – 45 %.
Other expenses for the Company’s operations – 10 %.
The Rights Issue
The Board of Directors of Moberg Pharma has today resolved to carry out an issue of new shares and warrants (Units) with preferential rights for existing shareholders of approximately SEK 150 million before transaction costs. The Rights Issue requires the approval of the Extraordinary General Meeting that will be held on December 1, 2020. Shareholders registered in the share register maintained by Euroclear Sweden AB on the record date of December 3, 2020 have the preferential right to subscribe for Units in relation to the number of shares the holder already owns. The application to subscribe for Units without exercising unit rights will also be possible.

The final terms of the Rights Issue, including the subscription price, increase of the share capital and the number of shares and warrants issued, are expected to be announced not later than November 27, 2020. The subscription period is expected to commence on December 7, 2020 up to and including December 21, 2020, or such later date resolved by the Board of Directors. For additional information, please see the notice to the Extraordinary General Meeting, which will be announced through a separate press release.

Preliminary timetable

November 27, 2020

Final terms for the Rights Issue are announced.

December 1, 2020

Extraordinary General Meeting to approve the Rights Issue.

December 2, 2020

First day of trading in the Moberg Pharma share, excluding the right to subscribe for Units by exercising unit rights.

December 3, 2020

Record date for the right to subscribe for Units by exercising unit rights.

December 7 – 21, 2020

Subscription period.

December 7 – 17, 2020

Trading in unit rights.

Complete terms and conditions as well as instructions for the Rights Issue as well as other information on the Company will be provided in the prospectus released before the commencement of the subscription period.

Subscription commitments and issue guarantees
The Rights Issue is comprised of approximately forty-two (42) percent subscription commitments and of approximately fifty-eight (58) percent issue guarantees. The Rights Issue is consequently fully guaranteed. Subscription commitments have been undertaken by, among others, the board members Peter Wolpert, Mattias Klintemar and Fredrik Granström, and the management consisting of Anna Ljung, Mark Beveridge and Torbjörn Wärnheim as well as by the Company’s major shareholder Östersjöstiftelsen. Subscription commitments have been undertaken by external subscription committers, like Nyenburgh Investment Partners and Fårö Capital AB. Issue guarantees have been guaranteed by external guarantors.

A guarantee commission will be paid for the issue guarantees, based on current market conditions, of nine (9) percent of the guaranteed amount in cash consideration. No consideration is to be paid for the subscription commitments that have been entered into. These subscription commitments and issue guarantees are not secured through bank guarantees, restricted funds, pledged assets or similar arrangements. Further information on the parties who have entered into guarantee commitments will be presented in the prospectus that will be released before the commencement of the subscription period.

Convertible note agreement
When the Rights Issue is completed, the Company intends to terminate the current convertible note agreement, which can be terminated at no cost for the Company. A final tranche of SEK 3 million in October is expected to be received in mid-November.

Lock up undertakings
Prior to the execution of the Rights Issue, the Board of Directors and management of the Company have entered into lock up undertakings, which, among other things and with customary exceptions, mean that they have undertaken not to sell shares in the Company for a period of 180 days commencing after the first day of trading in the ordinary shares and warrants that are issued in the Rights Issue.

Prospectus
A prospectus and notification form will be made available before the commencement of the subscription period on Moberg Pharma’s website, www.mobergpharma.se.

Advisor
Vator Securities is the financial advisor and Gernandt & Danielsson Advokatbyrå is the legal advisor to Moberg Pharma in connection with the Rights Issue.

On November 6, 2020 Triple-S Management Corporation (NYSE: GTS), a leading healthcare care company in Puerto Rico, reported its third quarter 2020 results (Press release, Triple-S Management, NOV 6, 2020, https://www.prnewswire.com/news-releases/triple-s-management-corporation-reports-third-quarter-2020-results-301167673.html [SID1234570204]).

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"Our strong third quarter performance reflects ongoing, improved performance resulting from our operational focus and enhanced organizational capabilities," said Roberto Garcia-Rodriguez, President and Chief Executive Officer. "This has led to sustained membership momentum and premium growth in a difficult environment, particularly in the government markets sector. Continuing this momentum, we are delivering a very competitive Medicare Advantage product for this year’s open enrollment period. Like most of our peer managed care companies, we have also experienced lower than planned utilization due to the impact of the ongoing pandemic.

"I am proud of our people, who continue to support our customers, providers and communities. Through their efforts, we are helping our members handle their medical needs safely and partnering with our providers and community organizations to assist our seniors and most vulnerable members during this challenging time.

"As we look to 2021 and beyond, we aim to be the preeminent healthcare company in Puerto Rico by delivering seamless holistic care through innovative models, state of the art technology and service excellence, in partnership with our providers."

Third Quarter 2020 Consolidated Results and Other Highlights

Net income of $23.6 million, or $1.02 per diluted share, versus net income of $13.9 million, or $0.58 per diluted share, in the prior-year period;
Adjusted net income of $14.2 million, or $0.61 per diluted share, a 17.4% increase versus adjusted net income of $12.1 million, or $0.51 per diluted share, in the prior-year period;
Operating revenues of $942.9 million, a 12.8% increase from the prior-year period, primarily reflecting higher Managed Care net premiums earned;
Consolidated loss ratio of 82.5%, a 90 basis-point improvement from the third quarter of 2019, reflecting higher premium rates and lower utilization;
Medical loss ratio ("MLR") of 84.7%, an improvement of 170 basis points over the same period last year;
Consolidated operating income of $22.3 million, a 17.4% increase compared to $19.0 million in the prior-year period;
Selected Consolidated Quarterly Details

Consolidated net premiums earned were $923.0 million, up 13.3% from the prior-year period, primarily reflecting higher Managed Care premiums.
Consolidated claims incurred were $761.8 million, up 12.0% year-over-year. Consolidated loss ratio was 82.5%, 90 basis points lower than the prior-year period, reflecting higher premium rates and lower utilization in the Company’s Managed Care segment.
Consolidated operating expenses of $158.8 million increased by $21.9 million, or 16.0%, from the prior-year period, primarily reflecting the reinstatement of the HIP fee in 2020 and expenses related to supplying much-needed assistance to our providers, communities and seniors to help them manage through the COVID-19 pandemic. The consolidated operating expense ratio was 17.1%, a 40 basis-point increase from the prior-year quarter.
Selected Segment Quarterly Details

Managed Care

Managed Care premiums earned were $850.0 million, up 13.9% year-over-year.
Medicare premiums earned of $400.7 million increased 9.2% from the prior-year period, largely due to an increase of approximately 20,000 member months, which primarily reflects a more competitive product offering and higher premium rates due to an increase in the premium rate benchmark and membership risk score. In addition, as utilization of services has trended to almost-normalized levels, the Company reduced the estimated MLR rebate accrual, which was originally recorded as a reduction of premiums.
Medicaid premiums earned of $240.9 million increased 36.6% from the prior-year period, primarily reflecting higher member months of approximately 67,000, higher average premium rates following three premium rate increases effective November 1, 2019, May 1, 2020 and July 1, 2020, and the reinstatement of the HIP Fee pass-through in 2020.
Commercial premiums earned of $208.4 million increased 2.6% from the prior-year period, mainly reflecting higher average premium rates, an increase of approximately 3,000 fully insured member months and the reinstatement of the HIP Fee pass-through in 2020.
Reported MLR of 84.7% improved 170 basis points from the prior-year period, primarily reflecting higher average premium rates and the reinstatement of the HIP Fee in 2020, as well as lower utilization of services during the quarter as the result of the pandemic, offset in part by increased benefits in the Medicare product offering in 2020.
Life Insurance Segment

Premiums earned of $50.1 million increased 9.4% from the prior-year period, resulting from new sales and the acquisition of a life insurance portfolio in the second quarter of 2020.
Operating income was $5.7 million, compared with $6.6 million in the prior year period, primarily caused by a higher actuarial reserve due to the reinstatement of policies that were cancelled during the second quarter of 2020 due to the COVID-19 lockdown.
Property and Casualty Segment

Premiums earned of $23.9 million increased 0.8% from the prior-year period.
Operating income was $4.4 million, compared with $6.6 million during the same quarter last year; this decrease was primarily caused by an increase in net commission expense.
Updated information related to Hurricane María as of September 30, 2020:
The Company’s P&C subsidiary has paid a cumulative amount of $767 million in claims and expenses related to Hurricane María. Estimated gross losses remain unchanged at $967 million.
TSP closed 75 claims during the third quarter of 2020, increasing the number of claims closed to 97.5%; 434 claims remain open.
The Company has been served with process with respect to 322 of the 434 claims that remain open.
2020 Outlook

The Company is raising its full year 2020 guidance for adjusted net income per diluted share to be between $3.25 and $3.35, compared to its previous outlook for adjusted net income per diluted share between $2.80 and $3.00. The Company is currently assuming a weighted average diluted share count for full year 2020 of 23.4 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, 2020. To participate, callers within the U.S. and Canada should dial 1-877-300-8521 and international callers should dial 1-412-317-6026 at least ten 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 for one year. This news release, along with other information relating to the call, will be available on the "Investor Relations" section of the website.