On September 30, 2021 AB Science SA (Euronext – FR0010557264 – AB) reported its revenues for the first half of 2021 and provides an update on its activities (Press release, AB Science, SEP 30, 2021, View Source [SID1234591054]).

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FINANCIAL SITUATION KEY ELEMENTS AS OF 30 JUNE 2021

Decrease of the operating loss

The operating loss as of 30 June 2021 was 6,040 K€, compared with 6,895 K€ as of 30 June 2020, a decrease in the operating loss of 855 K€ (12.4%). This decrease is mainly due to the decrease in research and development costs during the period.

Strengthening of the cash position and financial visibility

Total cash and current financial assets amounted to 17,646 K€ as of 30 June 2021. This amount does not take into account the €3.3 million of 2020 tax credit to be reimbursed by the Public Finance Department.

In addition, the amount of off-balance sheet commitments received as of 30 June 2021 was €90 million. These commitments include:

A loan agreement for a total amount of €15 million signed with the EIB in November 2020
A firm financing option from historical shareholders for an amount of €25 million in the next 12 months, at the initiative of AB Science
A commitment of an additional 50 million euros, at the rate of 25 million per year from the first anniversary date, 1 July 2022, subject to an absence of event clause significantly unfavorable

Off-balance sheet commitments are detailed in paragraph 22 of the appendix to the half-year consolidated accounts.

CLINICAL DEVELOPMENT KEY EVENTS DURING THE FIRST HALF OF 2021 AND SINCE JUNE 30, 2021

Progressive resumption of patient enrollment in ongoing masitinib studies

AB Science announced the progressive resumption of patient enrollment in the confirmatory Phase 3 study (AB19001) in amyotrophic lateral sclerosis, the confirmatory Phase 3 study (AB15003) in mastocytosis and the Phase 2 study (AB20001) in Covid-19.

This resumption follows the decision in June 2021 to voluntarily suspend the inclusion of new patients in clinical studies with masitinib after the detection of a potential risk of ischemic heart disease with masitinib, and the validation by the ANSM of a risk management plan proposed by AB Science to reinforce patient safety.

Launch of an antiviral treatment for Covid-19

Publication in the journal Science

AB Science announced publication of a peer-reviewed article titled ‘Masitinib is a broad coronavirus 3CL inhibitor that effectively blocks replication of SARS-CoV-2’ in the journal Science. The article reports on research that identifies masitinib as a broad antiviral agent capable of treating SARS-CoV-2 (the virus that causes COVID-19), including demonstration of in vivo activity in mice, with efficacy maintained, in vitro, against SARS-CoV-2 variants of concern.

Launch of a second Phase 2 study in Covid-19

AB Science announced it has received approval to commence a second Phase 2 study in Covid-19. This study will evaluate the antiviral efficacy of masitinib at 3 different dosages, administered as an add-on to best supportive care, with respect to placebo plus best supportive care. The primary efficacy objective will be to demonstrate that masitinib can reduce the viral load of SARS-CoV-2 (the virus responsible for COVID-19) faster than a placebo control group, which will receive best supportive care. The population of study AB21002 therefore targets ambulatory (non-hospitalized) patients with mild disease or hospitalized patients without requirement for non-invasive ventilation (a score of 4 and 5 on the WHO clinical progression scale for COVID-19).

Collaboration with the University of Chicago in order to develop masitinib back-ups as antiviral drugs

AB Science together with the University of Chicago, announced the signing of an exclusive licensing agreement for conducting research on the prevention and treatment of humans infected with nidoviruses, coronaviruses and picornaviruses.

Under this agreement, AB Science will supply masitinib and more than 130 other AB Science proprietary drugs that have demonstrated activity against SARS-CoV-2 main protease 3CL-Pro via virtual screening methodology, and will benefit from the proprietary research platform of the University of Chicago.

Publication of long-term data showing that masitinib extended survival in amyotrophic lateral sclerosis by 25 months, provided that treatment starts early in disease course

The survival analysis followed all patients originally randomized in study AB10015 for an average duration of 75 months from the date of diagnosis. In ALS patients with mild or moderate disease severity at baseline, it was seen that treatment with 4.5 mg/kg/day masitinib as an add-on to standard riluzole prolonged survival by 25 months relative to those treated with riluzole alone, with a 44% reduced risk of death. Patients with mild or moderate disease severity correspond closely to the patient cohort enrolled in confirmatory phase 3 study, AB19001.

This new survival data has been published in in the peer-reviewed journal Therapeutic Advances in Neurological Disorders.

Launch of a Phase I/II study with AB8939 in acute myeloid leukemia

AB Science announced that its clinical trial with AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML) has been approved by Health Canada.

AB8939 is a new generation synthetic microtubule destabilizer with the ability to overcome multidrug resistance and the potential for broad applicability as a potent anticancer drug.

The therapeutic potential of AB8939 has been demonstrated by preclinical results. In vivo data in a mouse model showed that AB8939, administered alone or in combination with Ara-C, increased survival compared to Ara-C alone.

AB8939 was entirely discovered by the laboratories of AB Science, which retains full ownership of intellectual rights, and is an example of AB Science’s focus on innovative drug development focused on improving patients’ lives.

Clinical results in Prostate Cancer

Masitinib Phase 2B/3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint. The study results were presented at the American Urological Association (AUA) 2021 Annual Meeting, held on September 10-13, 2021.

CONSOLIDATED FINANCIAL INFORMATION FOR THE FIRST HALF OF 2021

The operating loss at of June 30, 2021 was 6,040 K€, compared to a loss of 6,895 K€ as of June 30, 2020, i.e. a decrease in the operating loss of 855 K€ (12.4%).

Operating revenues, exclusively consisting of revenue from the operation of a veterinary medicine drug, amounted to 818 K€ as of June 30, 2021, compared to 807 K€ one year earlier.
Operating expenses amounted to 6,858 K€ as of June 30, 2021, compared to 7,702 K€ as of June 30, 2020, a decrease of 10.9%.
Marketing expenses decreased by 47.4% from 449 K€ as of June 30, 2020 to 236 K€ as of June 30, 2021.
Administrative expenses increased by 25.2%, from 1,059 K€ as of June 30, 2020 to 1,326 K€ as of June 30, 2021.
Research and development expenses decreased by 13.4%, from 6,121 K€ as of June 30, 2020 to 5,299 K€ as of June 30, 2021. This variation is explained by the end of a number of studies where masitinib is being developed, which has led to a decrease in clinical costs (clinical partners, hospitals, laboratories, etc.).

The financial income as of June 30, 2021 is a gain of 1,386 K€ compared to a loss of 1,897 K€ one year earlier.

As of June 30, 2020, the loss of 1,897 K€ is mainly related to the recognition in the IFRS consolidated accounts of the change in fair value of financial liabilities. This change resulted in a non-recurring, non-cash loss.
The gain of 1,386 K€ as of June 30, 2021 is also and mainly related to the recognition in the IFRS consolidated accounts of the change in fair value of financial liabilities. This variation generates a non-recurring gain with no effect on cash. As these liabilities are mainly composed of instruments convertible into ordinary shares, their fair value varies according to the price of the AB Science share, i.e. a decrease over the half-year.
The net loss as of June 30, 2021 amounts to 4 655 K€ compared to a loss of 8 801 K€ as of June 30, 2020.

The following table summarizes the consolidated financial statements for the first half of 2021 prepared in accordance with IFRS, and comparative information with the first half of 2020:

OTHER CORPORATE INFORMATION FOR THE FIRST HALF OF 2021

State-guaranteed loan (PGE)

AB Science has obtained in March and April 2021 the agreement of Société Générale, Bpifrance and Banque Populaire for a total of 6 million euros in financing in the form of a state-guaranteed loan (PGE – prêt garanti par l’État), in the context of the COVID-19 pandemic.

Each bank provided a loan of 2 million euros. This loan is 90% guaranteed by the French State, with an initial maturity of 12 months and an extension option of up to five years, exercisable by AB Science.

Agreement with historical shareholders to implement a joint strategy to increase the value of masitinib

AB Science announced that it has signed an agreement with historical shareholders to implement a joint strategy to increase the value of masitinib. Under this agreement, these historical shareholders, representing today 8.7% of the company’s share capital, undertake to act in concert with the founding shareholders of AB Science in order to:

study strategies to optimize the value of masitinib, in particular in the context of a potential strategic alliance with one or several pharmaceutical company(ies) for the clinical development and commercialization of masitinib in one or more major indication(s), and/or in one or more major region(s); and
to study the opportunity of listing AB Science on a foreign market, in particular the NASDAQ (through an American Depository Receipts program).
The agreement will be implemented subject to the condition of obtaining a final exemption decision from the French Autorité des Marchés Financiers, free and clear of any appeal, confirming that there is no need for a public offer.

This agreement also includes the signature of a firm financing option for an amount of €25 million over the next 12 months, at the initiative of AB Science. These financings will have to be carried out within the framework of the "private placement" or "capital increase reserved for categories of persons" resolutions that are currently in place. With this agreement, AB Science’s financial visibility is extended beyond 24 months. This funding commitment may be increased by an additional 50 million euros, at the rate of 25 million euros per year from the first anniversary date, subject to a clause of absence of significantly unfavorable event.

Finally, this agreement includes a lock-up by certain minority shareholders on 1.8 million shares for a period of three years (or until the implementation of the value enhancement strategy if this occurs before the end of the three-year period).

Changes in the Board of Directors

AB Science has announced the reorganization of its Board of Directors with the co-optation of four new independent directors, Cécile de Guillebon, replacing Nathalie Riez, Catherine Johnston-Roussillon, replacing Emmanuel Mourey, Guillemette Latscha, replacing Béatrice Bihr, and Renaud Sassi, replacing Jean-Pierre Kinet.

Shareholders’ agreements expiring in 2021

Some agreements expire in 2021. All these agreements are described in chapter 8.5 of the annual financial report as of December 31, 2020.

Other events

Other securities transactions

During the first half of 2021, 21,845 share subscription warrants were granted.

Other information

AB Science confirms its eligibility for PEA-PME (a share savings plan aimed at providing finance to SMEs) in accordance with decree no. 2014-283 of 4 March 2014 taken for the application of article 70 of law no. 2013-1278 of 29 December 2013 of finance for 2014 fixing the eligibility of companies for PEA-PME, i.e. less than 5,000 employees on the one hand, an annual turnover of less than 1,500 million euros or a total balance sheet of less than 2,000 million euros, on the other hand.

On September 30, 2021 Race Oncology Limited ("Race") reported to share interim results from our collaborative preclinical melanoma research program with the University of Newcastle (ASX Announcement: 19 Mar 2021) (Press release, Race Oncology, SEP 30, 2021, View Source [SID1234591003]). Eminent melanoma researchers, Professor Xu Dong Zhang and Associate Professor Lei Jin, are leading the project.

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This program is exploring the use of Zantrene (bisantrene dihydrochloride) as a novel potential treatment for melanoma using cellular and mouse models. The aim is to identify drug combinations and melanoma subtypes that show improved treatment responses, with a focus on treatment-resistant melanomas.

These interim results showed Zantrene to be highly effective at killing a diverse range of high FTO producing melanoma cell subtypes. Data from the expression of the Fat Mass and Obesity-associated protein (FTO) showed an association between FTO expression level and sensitivity to Zantrene.

Zantrene has been identified as a potent targeted inhibitor of the Fat Mass and Obesity associated protein (FTO)1. Previous studies have observed that FTO is over-produced in approximately 50% of metastatic melanomas2 and that inhibition of FTO can overcome PD-1 immune checkpoint resistance in mouse melanoma models2,3. PD-1 immune checkpoint inhibitors have emerged as a front-line treatment for many types of cancer, including melanoma. While there have been major advances in melanoma treatments in recent decades, the five-year survival rate for advanced melanoma remains low4.

"These interim results are highly encouraging and support our clinical plans for Zantrene, with the correlation between FTO overexpression and sensitivity to Zantrene suggesting a strong anti-FTO therapeutic opportunity. The high sensitivity of many of the melanoma cell lines to Zantrene as a single agent at concentrations well below chemotherapeutic doses is unexpected and may offer new treatment options for melanoma patients."

Race CSO Dr Daniel Tillett
"While challenged by COVID 19 related shutdowns we appreciate the encouraging and continued work from the team at the University of Newcastle. Zantrene continues to positively surprise us – we are very pleased with these early results. Melanoma remains a difficult cancer to treat, and one that’s of particular relevance to the Australian community, so as we continue with this work, we look forward to learning more about our potential to offer new treatment options to patients."

Race CEO & MD Phillip Lynch
Study Background
Melanoma is unresponsive to existing anthracyclines, yet Zantrene showed significant historical in vitro activity against fresh human melanoma samples taken from patients in human tumor cloning assays5,6. In a subsequent Phase I trial of Zantrene administered weekly, a patient with metastatic melanoma achieved a complete response lasting 6 months7. This weekly dosing schedule would likely have resulted in sustained inhibition of FTO due to the long time Zantrene remains in the human body.

Despite these early successes, four subsequent Phase 2 studies of Zantrene in 100 melanoma patients used much longer dosing intervals of once every three or 4 weeks and did not achieve the same levels of clinical response, possibly due to limited, transient inhibition of FTO8-11. Seventeen patients (1/16, 2/16, 0/17, 14/51) achieved disease stabilization, but no further complete responses were observed.

In light of the recent discovery that Zantrene is a potent inhibitor of the m6A RNA demethylase FTO1 and that FTO is frequently overexpressed in metastatic melanoma2, Race sought to explore the use of Zantrene for treating melanoma, both as a single agent and in combination with other standard of care drugs. This research will also help inform the dose regimen to be explored in future clinical trials.

Study Highlights
1. Zantrene is highly effective in killing melanoma cells at sub-chemotherapeutic levels
Zantrene proved to be highly effective at killing melanoma cell lines, with 60% (15 of 25) displaying IC50 values below 100 nM concentrations (Table 1). This was seen with cell lines derived from both primary and metastatic melanoma patients. Interestingly, six of the 25 cell lines showed extreme sensitivity to Zantrene (IC50 values under 40 nM), suggesting that Zantrene may provide an effective single agent treatment for some patients.

The untransformed melanocyte cell line (normal) was highly resistant to cell killing by Zantrene, as were some of the melanoma cell lines (Table 1). The molecular mechanisms underlying this resistance to Zantrene remain to be determined.

Cell Line IC50 (nM)
HEMm-MP 1403
MEL-BP 1003
SK-MEL-110 1002
SK-Mel-28 515
Mel-JD 335
MM426 312
Mel-RM 178
Mel-RMu 167
Mel-CV 115
Mel-FH 102
MM200 96
A375 87
MM170-5 85
MM283 79
ME1007 78
SK-MEL-37 75
IgR3 72
SK-MEL-13 67
ME4405 53
MEL-BE 39
MV3 39
MEL-EH 37
MEL-JR 30
MEL-KD 28
MM962 23

Table 1. IC50 values for Zantrene
2. Sensitivity to Zantrene is independent of BRAF and NRAS mutational status
Zantrene sensitivity did not show any correlation to either BRAF or NRAS mutational status, with individual mutant and wild type cell lines displaying a wide range of IC50 values. This result suggests that Zantrene may show utility in patients resistant to BRAF and NRAS inhibitors.

Cell Line IC50 (nM) BRAF NRAS
HEMn-MP 1403 Wild Wild
SK-Mel-28 515 Mutant Wild
Mel-JD 335 Wild Mutant
Mel-RM 178 Wild Mutant
Mel-Rmu 167 Mutant Wild
Mel-CV 115 Mutant Wild
Mel-FH 102 Wild Wild
ME1007 78 Wild Wild
MM200 96 Mutant Wild
IgR3 72 Mutant Wild
ME4405 53 Wild Mutant
Table 2. Effect of Zantrene on BRAF and NRAS mutant cell lines.
3. Sensitivity to Zantrene correlates with FTO expression levels
Zantrene sensitivity was correlated with FTO protein overexpression levels (Figure 1 and Table 3).

Figure 1. FTO protein expression determined by western blot.
The eight most Zantrene-resistant cell lines (i.e. those with an IC50 values greater than 100 nM) had a median FTO expression level 1.4 fold higher that of the untransformed (normal) melanocyte cell line, HEMn-MP.

In contrast, the 15 most sensitive melanoma cell lines had a median increase in FTO protein levels of 2.5 fold. The five most sensitive cell lines (i.e. those with IC50 values below 40 nM) had an average increase in FTO protein levels 3.8 fold higher (Table 3).

Cell Line FTO Level
HEMm-MP 1.0
Mel-BP 2.2
SK-MEL-110 5.0
SK-Mel-28 1.0
Mel-JD 1.3
MM426 2.8
Mel-RM 1.6
Mel-RMu 1.4
Mel-CV 1.4
Mel-FH 2.6
MM200 1.1
70W 1.9
MM170-5 3.5
MM283 2.4
ME1007 1.3
SK-MEL-37 2.4
IGR3 2.7
SK-MEL-13 4.4
ME4405 2.0
Mel-BE 1.7
MV3 5.8
Mel-EH 2.2
Mel-JR 3.6
Mel-KD 2.5
MM962 5.0
Table 3. FTO protein levels normalized to the FTO level of the normal human melanocyte cell line HEMn-MP.
The SK-MEL-10 was an exception to the trend of high FTO overexpression being associated with high sensitivity to Zantrene. This cell line had an IC50 value over 1000 nM while displaying an FTO expression level 5 fold that of HEMn-MP. The reason for this resistance is unknown, but may be linked to high expression of drug efflux pumps like MDR1 that are known to reduce the intracellular concentration of Zantrene.

Conclusions
Zantrene showed unexpectedly effective killing of melanoma cell lines at concentrations well below 100 nM (sub-chemotherapeutic), with a number of cell lines displaying very high sensitivity (less than 40 nM)
Zantrene proved effective at killing melanoma cell lines with BRAF or NRAS mutations
Sensitivity to Zantrene was correlated with overproduction of the FTO protein, supporting Race’s clinical plans for using Zantrene in combination with standard of care drugs for the treatment of melanoma patients.

On September 30, 2021, Exicure, Inc. ("Exicure") and Exicure Operating Company, Exicure’s wholly owned subsidiary (collectively with Exicure, the "Company") reported that entered into an amendment ("Amendment No. 3") to the Company’s Credit and Security Agreement, dated as of September 25, 2020, as amended on October 21, 2020 and July 30, 2021, with MidCap Financial Trust, as agent, and the lenders party thereto from time to time (as amended by Amendment No. 3, the "Credit Agreement") (Filing, 8-K, Exicure, SEP 30, 2021, View Source [SID1234590895]).

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Amendment No. 3 extends the availability of the second advance of $7.5 million under the Credit Agreement from September 30, 2021 to December 31, 2021, subject to the Company’s satisfaction of certain applicable funding conditions as described in Amendment No. 3, including i.) Exicure’s issuance of equity interests, subject to certain limitations, resulting in receipt by Exicure of unrestricted net cash proceeds of at least $20.0 million, and ii.) the contribution by Exicure, and receipt by Exicure Operating Company, of such cash proceeds to the capital of Exicure Operating Company.

On September 30, 2021 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and biologic cancer therapeutics, reported its corporate name change from Rgenix to Inspirna and announced the appointment of Dieter Weinand to its Board of Directors, where he will serve as Chairman (Press release, Rgenix, SEP 30, 2021, View Source [SID1234590622]).

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"Given the recent progress made advancing our novel oral small molecule programs RGX-202 and RGX-104 through the clinic, and in anticipation of executing on upcoming milestones, we knew this was an opportune time to align our company name with the science on which our pipeline is based," said Masoud Tavazoie, M.D., Ph.D., and Chief Executive Officer of Inspirna. "Our new name and logo combine our desire to inspire the development of new cancer medicines with our proprietary RNA-based target discovery platform, and we believe this name now more closely aligns with our mission to develop novel therapeutics that can uniquely benefit patients with difficult to treat cancers."

The Company currently has two clinical trials ongoing, including a Phase 1b study of RGX-202, a novel oral small molecule in development for colorectal cancer (CRC), and a Phase 1b/2 study of RGX-104, a novel oral small molecule in development for several lung cancer indications, including small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Additionally, RGX-019, a novel biologic drug candidate, is in preclinical testing in select solid and liquid tumors. Inspirna plans to provide an update on its programs at its upcoming virtual R&D Day.

Inspirna also announced the appointment of Dieter Weinand to its Board of Directors. Mr. Weinand, formerly CEO of Bayer Pharma AG, brings over 30 years of experience across the pharmaceutical and biotechnology industries.

"We are thrilled to welcome Dieter to Inspirna," said Dr. Tavazoie. "A seasoned executive in the pharma and biotech industries, his insight will be invaluable as we work to advance our drug candidates through the clinic. He has guided companies across various therapeutic areas, including oncology, from the clinical phase through launch and commercialization, and we look forward to benefitting from his expertise."

"I am delighted to be joining the Inspirna Board of Directors as Chairman at this time of tremendous progress for the Company," said Mr. Weinand. "I am impressed with the clinical and preclinical work the Company has completed thus far and was drawn to the RNA technology on which the pipeline is founded, which I believe has the potential to provide new treatment options for patients with cancer."

Prior to his most recent role as CEO of Bayer Pharma AG, Mr. Weinand held senior leadership positions at Pfizer, Bristol-Myers Squibb, and Sanofi, with responsibilities ranging from management and strategy to operations and commercialization. He has led the launch and marketing of numerous products, including those in primary care, specialty care, and oncology. Mr. Weinand sits on several boards as Chairman, including Replimune, ForeBio, Mnemo and ZielBioPharma. Additionally, he is a director of FieldTrip Health. Mr. Weinand earned his M.S. in pharmacology and toxicology from Long Island University and his B.A. in biology from Concordia College.

Virtual R&D Day on Tuesday, October 26th

Inspirna will host a virtual R&D Day on Tuesday, October 26th, 2021 at 3:00 PM ET. The private event will be open to analysts and investors. Details will be provided to invitees separately. Those interested in attending the event should contact [email protected].

On September 30, 2021 Signify Health (NYSE: SGFY), a leading value-based healthcare platform that leverages advanced analytics, technology and nationwide healthcare provider networks, and HealthComp, the largest independent health benefits administrator in the country, reported a new strategic collaboration to give self-funded employer groups an affordable health benefits package that embeds value-based payments with value-based benefits design (Press release, Signify Health, SEP 30, 2021, https://www.signifyhealth.com/news/signify-health-and-healthcomp-collaborate-to-develop-value-based-health-benefits [SID1234590621]).

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"Having successfully built a value-based care platform to support providers, employers, and health plans who are committed to improving patient outcomes, our collaboration with a leading third-party administrator such as HealthComp opens up new opportunities to drive the transformation away from the broken fee for service model," said Peter Boumenot, Chief Product Officer, Signify Health. "We believe that converging value-based payments with value-based benefit design is essential for all stakeholders at both the individual and the population levels. HealthComp’s proven capabilities will help us bridge this gap for employers across the country who are looking for turnkey solutions that improve costs and outcomes."

"The majority of the employers we work with are looking for new ways to strengthen the alignment of cost, quality and member satisfaction with their benefits offerings," said Justin Tran, Senior Vice President of medical cost management at HealthComp. "By working with Signify Health, we have a unique opportunity to bring together advanced alternative payment models with advanced benefits designs that deliver the clinical and operational excellence needed to address the root causes of suboptimal health outcomes and increasing costs."

Employers are increasingly adopting value-based insurance designs (VBID), which align the appropriate use of high value healthcare services with the engagement of high-performance providers who are accountable for health outcomes. A new white paper published by VBID Health describes how VBID and alternative payment models can be brought together to improve overall health and lower the costs of healthcare delivery and references many of the tools that are available for employers working in collaboration with providers, third-party administrators, and carriers. Early results of similar payment arrangements with Signify Health have shown a promising reduction in both health plan spend and adverse clinical events for members engaged in the program.

The partnership will focus on leveraging Signify Health’s leading capabilities in episode-based financing and high-value provider networks, along with HealthComp’s innovative approach to comprehensive benefits administration and member engagement, to create more affordable, predictable, transparent, and member-focused benefit design. Value-based benefits developed by HealthComp and powered by Signify Health’s value-based payment platform will be offered in select markets across the U.S.