MeMed raises $93M to accelerate commercialization of its host immune-response product portfolio

MeMed raises $93M to accelerate commercialization of its
host immune-response product portfolio

MeMed BV® test recently cleared for use by US FDA to aid in distinguishing between bacterial and viral infection on the point-of-need platform MeMed Key®

HAIFA, Israel; BOSTON, MA; January 10th, 2022 – MeMed, a leader in host response technologies, today announces a $93 million private financing round, bringing total funding in the Company to over $200 million, including support from the U.S. Department of Defense and EU Commission. Funds will be used to scale up manufacturing, accelerate commercialization and expand MeMed’s pioneering host immune response product portfolio.

MeMed’s technology suite decodes the body’s immune response within minutes, providing physicians with important patient management solutions that tackle key clinical dilemmas. The U.S. Food and Drug Administration (FDA) recently granted a landmark clearance for the use of the MeMed BV® test on the point-of-need platform MeMed Key®, to help healthcare providers distinguish between bacterial and viral infections in both children and adults. MeMed has also developed the MeMed COVID-19 Severity™ test for predicting severe outcomes in COVID-19 patients, which has been cleared for use in Europe.

The latest financing brings together new and existing investors including Horizons Ventures, Shavit Capital, Social Capital, La Maison Partners, Touchwood Capital, Caesara Medical Holdings, Union Tech Ventures, ClaI Insurance, Phoenix Insurance, Poalim Equity and Western Technology Investment.

Eran Eden, MeMed’s co-founder and CEO, said: “This new investment will enable MeMed to expand operations with a focus on the U.S. We are grateful to our investors for their support and will leverage the funds, the recent FDA clearance, and our growing network of partnerships to provide broad patient access to our technology, as well as expand our product portfolio of pioneering host response solutions.”

Patrick Zhang, Horizons Ventures, said: “We strongly believe that MeMed’s strategy of using host immune response technologies is a significant advance in the improvement of two major issues in healthcare today: the rise of antimicrobial resistance due to unnecessary prescription of antibiotics and effectively triaging patients infected with COVID-19. We look forward to playing a role in how MeMed, a category leader in this area, is transforming the way diseases are diagnosed and treated to improve patient healthcare across the globe.”

About MeMed
Our mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. For additional information on MeMed, please visit http://www.me-med.com.

MeMed Contacts:
Media: Will Harris, VP Marketing, MeMed
pr@me-med.com

IR: Kfir Emmer, CFO, MeMed
kfir.emmer@me-med.com

Media Contacts:
Consilium Strategic Communications
MeMed@consilium-comms.com

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Nyxoah Provides General Corporate Update

Nyxoah Provides General Corporate Update

Transformational 2021 positions Nyxoah for further clinical, regulatory, and commercial milestones in 2022

Mont-Saint-Guibert, Belgium – January 10, 2022, 7:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today provided a general corporate update.

2021 Highlights

  • Implanted first U.S. patient in the DREAM IDE pivotal study in December 2020; there are currently 15 active and enrolling patient sites in the U.S., with implants expected to be completed in Q1 2022
  • Secured CE Mark MR conditional labeling for the Genio® system in January, ensuring that implanted patients can undergo full-body 1.5T and 3T MRI diagnostic scans
  • Raised $97.8 million in a Nasdaq initial public offering in July, successfully completing Nyxoah’s second IPO after previously raising $100 million in the September 2020 Euronext Brussels IPO
  • Granted U.S. FDA Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate in September; engaged in sprint discussions with FDA regarding the IDE study for CCC patients in the U.S., which Nyxoah hopes to commence in the second half of 2022
  • Received expanded CE Mark indication to treat CCC patients in October, thus increasing Nyxoah’s total addressable market by at least 30% and thereby enabling patients not to have to undergo a Drug-Induced Sleep Endoscopy (DISE) procedure prior to Genio® implantation
  • Made strong commercial progress in Germany after obtaining a dedicated DRG code in January
  • Obtained DRG coding in Switzerland in March and secured first revenue in Spain; submitted reimbursement files in other key European markets
  • Entered exclusive licensing agreement with Vanderbilt University in February to develop next generation neurostimulation technologies, specifically a stimulator focused on the Ansa Cervicalis, which innervates the palatoglossus and/or the palatopharyngeus muscle; this collaboration has thus far resulted in initial prototyping discussions, and Nyxoah expects to make further progress on this project in 2022
  • Appointed Loic Moreau as Chief Financial Officer effective January 1, 2022, replacing Fabian Suarez, who is pursuing a new opportunity as CEO of a startup MedTech company
  • Announced the appointment of Rita Johnson-Mills to the Board of Directors in August

“2021 was a transformational year for Nyxoah as we achieved several important clinical, regulatory, commercial, and financial accomplishments and set ourselves up for continued progress in 2022 and beyond,” said Olivier Taelman, CEO of Nyxoah. “On the clinical front, we announced that our BETTER SLEEP clinical trial achieved a statistically significant mean reduction in the Apnea Hypopnea Index (AHI) from baseline to six months post implantation for the entire cohort as well as for the subgroup of patients with Complete Concentric Collapse (CCC) of the soft palate. We will be submitting the full data set for journal publication and look forward to discussing more fully once the data are published, hopefully in the first half of 2022. We are extremely encouraged by the data generated by BETTER SLEEP, which were used by our notified body DEKRA to expand our CE Mark indication to include CCC patients as well as by FDA in granting us Breakthrough Device Designation for the treatment of CCC patients in the U.S. We are also excited to partner with Dr. David Kent and his team at Vanderbilt University on the development of a next generation device that stimulates the Ansa Cervicalis, which Dr. Kent’s research suggests could be another effective way to treat OSA patients, and we look forward to advancing our work in creating a stimulator that leverages this novel approach.”

Mr. Taelman continued, “As we begin 2022, our primary clinical focus is on our DREAM U.S. IDE pivotal study in which patient enrollment and implants are well underway, and we still expect to complete our target of 134 implants by the end of Q1 2022. We continue to generate great enthusiasm from physicians and patients as we activate more sites and enroll more patients, and we are seeing implant rates accelerating as we move into the new year. We have also been encouraged by our sprint discussions with FDA regarding our IDE trial for CCC patients in the U.S., which we hope to commence in the second half of 2022. From a commercial standpoint, we have made tremendous progress in our key geographic markets, securing DRG codes in Germany and Switzerland, obtaining hospital reimbursement in Spain and awaiting reimbursement decisions in Belgium, the Netherlands, and the Nordic countries. Our commercial strategy centers on the concept of going deep as opposed to going wide; in other words, we want to focus our strategy on key Centers of Excellence with high levels of clinical expertise and patient care, large patient pools, and well-coordinated clinical and administrative infrastructures. This strategy, combined with our ability to treat CCC patients, has enabled us to gain meaningful market share in Germany, and we expect to exit 2022 as the market leader in that important country.”

Mr. Taelman concluded, “As proud and excited as we are of our significant accomplishments in 2021, we have our sights set much higher for 2022. Aiding our efforts is a strong balance sheet that we bolstered in July with close to $100 million raised in our Nasdaq IPO, less than one year after raising close to $100 million in our Euronext IPO in September 2020. This liquidity gives us ample flexibility to complete the DREAM study, conduct the ACCCESS study, invest further in our existing commercial operations, and begin to build out a U.S. commercial operation in anticipation of launch following FDA approval. We are extremely well positioned to execute on our clinical, regulatory, and commercial initiatives, and we look forward to providing further updates on our progress as the year unfolds.”

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements 
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

Gilmartin Group 
Vivian Cervantes
IR@nyxoah.com

 

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Supreme Court Suspends SHC’s Order on FBR Notices to Foreign Asset Holders

On the plea of the Federal Board of Revenue (FBR), the Supreme Court of Pakistan has suspended the Sindh High Court (SHC) order which declared illegal the issuance of FBR notices to the Pakistanis pertaining to their overseas assets, income, and expenses. However, it has granted leave to appeal against the suspension.

A three-member bench of the apex court headed by Justice Umar Atta Bandial heard the FBR plea.

Earlier, SHC had declared FBR’s notices null and void and illegal in December 2020.

The FBR lawyer stated during the hearing that in accordance with Income Tax Ordinance-2001, all the Pakistanis having assets or income abroad were obligated to declare their assets, income, and expenses along with their annual returns.

To comply with the stated legal provision, FBR had issued the notices to the Pakistanis having foreign source income or assets abroad but had not declared them along with the Income Tax Returns. Therefore, some individuals preferred to appeal before Sindh High Court against the issuance of notices by FBR and pleaded before the court to declare the notices as illegal.

While accepting the plea of hearing appeal, the Supreme Court stated that notices issued by FBR could not be challenged before the High Court as per law settled by the apex court.

Source: Pro Pakistani

Rupee Shows No Recovery Against the US Dollar Even After IMF News

The Pakistani Rupee (PKR) managed to hold out against the US Dollar (USD) in the interbank market today. It hit an intra-day high of Rs. 176.55 against the latter during today’s open market session.

While redundant, it depreciated by 0.01 percent against the USD and closed at Rs. 176.68 today after gaining 24 paisas and closing at 176.67 in the interbank market on Friday, 7 January.

The rupee managed to hold its own against the USD after news that the Executive Board of the International Monetary Fund (IMF) has rescheduled the assessment of the Sixth Review and the delivery of a $1 billion tranche under the Extended Fund Facility (EFF) after a request from the Pakistani authorities.

An official statement by the Ministry of Finance explained that the government has introduced the amended Finance and SBP Autonomy bills in the National Assembly and that the IMF’s board will consider it for approval as soon as the procedural formalities are completed.

The bills must be cleared for the IMF Executive Board to resume Pakistan’s $6 billion loan program. The government hopes to pass the bills before the meeting of the IMF’s Board of Directors on 12 January. If passed, the bills will help to generate more revenues to the tune of Rs. 343 billion, and subsequently support the local exchange unit.

In light of the PKR’s interbank performance during the trading hours earlier today, the former Treasury Head of Chase Manhattan Bank, Asad Rizvi, tweeted, “Couple of IMF related news appearing in the press about [the] change of mission leader in Pakistan & removal of Pakistan’s agenda from the IMF Executive Board calendar needs official clarification. It may not help & possibility is that Financial market would react negatively”.

Conversely, the PKR reversed most of its gains against other major currencies in the interbank currency market today. It posted losses of 55 paisas against the Euro (EUR), Rs. 1.01 against the Pound Sterling (GBP), Rs. 1.08 against the Canadian Dollar (CAD), and 68 paisas against the Australian Dollar (AUD).

Conversely, it held out against both the Saudi Riyal (SAR) and the UAE Dirham (AED) in today’s interbank currency market.

Source: Pro Pakistani

Major Investors Are Interested in Installing LNG Terminals at Karachi, Gwadar

An overwhelming number of investors have shown their interest in the establishment of LNG terminals/ virtual pipelines at Karachi and Gwadar Ports, and applications for at least seven LNG licenses are in various stages of considerations.

According to official documents available with ProPakistani, as of December 2021, a total of seven applications are pending for licenses or NOCs; four applications are pending with the Oil and Gas Regulatory Authority (OGRA); while three applications are pending with Port Authorities.

According to the documents, Gwadar Gasport Limited (GGPL), after entering an agreement with GITL, applied for a grant of provisional Licence on 4 March 2021 to OGRA, which was evaluated under the provisions of Rule 33 of LNG Rules 2007.

The OGRA sought the status of consent from GPA, which is required under Rule 4(3)(b) of LNG Rules 2007. As per the project detail, Gwadar International Terminal Limited (GITL) and Gwadar Gas Port(Pvt) Limited (GGPL) signed an agreement on 17 December 2020 to develop a fast track LNG import terminal at Gwadar Port and to deliver gas without using any government-owned gas infrastructure in the country.

The project envisages that it shall have a Floating Storage Unit (LNG vessel) to be berthed permanently at Berth 3 of the Port. LNG will be discharged from FSRU into ISO road tankers. ISO tankers will provide an uninterruptable supply of LNG (in the small storage tank) placed at the customer premises where vaporizers for re-gasification of LNG will be installed. However, on approaching GPA for consent, they have conveyed through the Ministry of Maritime Affairs(MoMA) not to entertain the application of GGPL till clearance from them. The Provisional License has, therefore, not been issued so far by OGRA.

Regarding NOC/Consent by GPA, the GPA and MoMA are of the view that Gwadar Port Master Plan offers a detailed plan and dedicated location for the establishment of the Gas terminal and associated onshore and offshore installation. It was suggested that a potential LNG terminal developer may submit a proposal to GPA for the establishment of such activity in a dedicated location as per the approved Gwadar Port Master Plan Instead of the utilization of General Cargo Berth.

The Metro Gas (Private) Limited applied to Oil and Gas Regulatory Authority(OGRA) for Provisional License on 26 October 2021. The company wants to establish an LNG terminal at Karachi Port. However, it has not yet been granted a license as they don’t have consent from the relevant Port Authority.

LNG Flex Limited has applied for a provincial license dated 8 October 2021. The company is interested to establish a terminal at Karachi Port and Port Qasim. A letter from Karachi Container Terminal (KICT) and a Memorandum of Understanding with Qasim International Container Terminal (QICT) have been provided. However, the Provisional License was not yet granted as NOC from KPT or Port Qasim Authority are missing, the documents reveal.

Shahzad LNG (Private) Limited applied for OGRA for a provisional License dated 26 October 2021. However, it has not yet been granted as they don’t have consent from the relevant Port Authority.

Shahzad LNG (Private) Limited has not yet defined its port of interest.

Other applications with Port Authorities, Daewoo Gas (Private) Limited (DGPL) at Gwadar Port. DGPL has approached Gwadar Port Authority (GPA). Similarly, Daewoo Gas (Private) Limited (DGPL) has acquired Global Energy Infrastructure Pakistan (GEIP), which was planning to establish an offshore Floating Storages Regasification Unit(FSRU) based LNG import terminal.

DGPL has approached Port Qasim Authority (PQA) with a proposal to establish a virtual LNG terminal at the same site.PQA doesn’t consider the GEIP Implementation Agreement valid any longer. DGPL claims that most requisite studies have already been conducted for LNG handling at this site, therefore, a terminal at this site can be established in a shorter time.

Another applicant is First Dawood Investment Bank which has approached Karachi Port Trust for establishing an LNG handling terminal at KPT. It is worth mentioning here that two LNG terminals are already operating, while licenses to another two had been issued by OGRA last year.

Source: Pro Pakistani

Here’s How International Lenders Are Making Billions from Pakistan

International banks like the China Exim Bank and the International Islamic Trade Finance Corporation (ITFC) are charging up to 6.5 percent interest per annum on lending to Pakistan while loans from Italy and China Development Bank are interest-free.

According to the official record on the terms and conditions of the donors’ lendings available with ProPakistani, Japan International Cooperation Agency (JICA) and Korea International Cooperation Agency (KOICA) are charging 0.10 percent and 0.1 percent respectively on their loans to Pakistan.

The International Islamic Trade Finance Corporation (ITFC), which is a subsidiary organ of the Islamic Development Bank (IsDB), has charged five to six percent per annum on its short-term trade financing (Murabaha). The repayment schedule and maturity period of the ITFC loan was one year, and there are no commitment charges, no service charges, and no penalty if it is not paid on time.

Additionally, four to 4.25 percent per annum is being charged on Turkish lending and there are commitment charges of 0.50 percent. There is also no grace period for the Turkish loan, no service charge, and no penalty if it is not paid on time. Also, the repayment schedule and maturity period of the Turkish loan are 10 to 14 years.

The China EXIM bank is providing a government concessional loan (GCL) at two percent interest, with a 5-7 year grace period, with management fee and commitment charges of 0.20 percent each. The repayment and maturity period of the lending is 15-20 years. The China EXIM bank offers a preferential Buyer Credit at two to three percent interest with the grace period of five to seven years, with the management fee and commitment charges of 0.20 percent each. The repayment and maturity period of the lending is 15 to 20 years.

The China EXIM bank is also providing Buyer Credit at Libore+220 t0 350 basis points (bps) or fixed 6.5 percent per annum, with a grace period of five to seven years. The lending has a management fee of 0.75 percent and commitment charges of 0.50 percent. The repayment and maturity period of the lending is 15-20 years.

Asian Infrastructure & Investment Bank (AIIB) is providing loans at 0.7 percent to 1.40 percent, depending on the tenure with a grace period of 5-7 years. The loan has a management fee and commitment charges of 0.25 percent each. The repayment and maturity period of lending is eight to twenty years.

Similarly, the International Fund for Agricultural Development (IFAD) is providing blend terms loan at 1.25 percent per annum with a grace period of five years. The repayment schedule and maturity period of the lending is 25 years (including five years grace period). The service charge for the loan is 0.75 percent.

The Islamic Development Bank(IDB) is providing project financing long-term loans (Istisna and Ijara) at an interest rate of three to four per annum, with a grace period of five years. The repayment schedule and maturity period of the lending is 15 years.

The Kuwait Fund is charging 1.5 percent to 2.5 percent on the loan having a grace period of six years. The loan also has an additional charge of 0.5 percent and a special commitment of 0.5 percent. The repayment schedule (maturity period) of the loan is 20 years.

The Saudi Fund is charging a two percent interest rate with a grace period of five years. The repayment and maturity period of the lending is 20 years with a two percent penalty if it is not repaid on time.

France/AFD is providing lending on six-month Euribor plus 48-125bp, with a three to seven year grace period. The repayment and maturity period of the lending is 15-30 years. As a penalty, late repayment interest will accrue without any formal notice from the lender within the limits permitted by law on interest overdue for one year or more at the interest rate applicable to the relevant interest period (late-payment interest) plus 3.5 percent (Default Interest).

The OPEC Fund for International Development (OFID) is providing project financing long-term loans at 1.7 percent per annum with a grace period of five years. The lending has commitment charges of one percent and it has a repayment and maturity period of 15 years.

Korea is charging 0.1 percent interest on its lending with a grace period of 10 years, with no commitment charge. The repayment schedule (maturity period) of the loan is 30 years and will charge a two percent penalty per annum if not repaid on time.

The Asian Development Bank (ADB) is providing Market Based Lending (MOL) of LIBOR six month+50 basis points, with a grace period of five years and 0.15 percent commitment charges on an undisbursed amount. The repayment schedule and maturity period of the loan is 25 years (including the grace period of 5 years). The ADB will also provide Concessional OCR lending(COL) at two percent per annum with a five-year grace period and 0.15 percent commitment charges on the undisbursed amounts. The repayment schedule and maturity period of the loan is 25 years (including the grace period of five years).

The Japan International Cooperation Agency (JICA) provides concessional loans to Pakistan at 1.30 percent, with a 10-year grace period and charging 0.10 percent commitment charges. The repayment schedule (maturity period) of the loan has 30 years (including a grace period of 10 years) and 0.1 percent service charges.

The JICA is providing a STEP loan at 0.10 percent with 10 years grace period and charging 0.10 percent commitment charges. The repayment schedule (maturity period) of the loan has 40 years (including a grace period of 10 years) and 0.1 percent service charges.

The World Bank (WB) is providing IDA loans, IDA(SUF) loans, and IBRD loans. It charges 1.25 percent for IDAs, with a five-year grace period and 0 to 0.5 percent commitment charges (currently set at zero percent). The repayment schedule (maturity period) of the loan is 25 years (including a five-year grace period). Additionally, the service charge is 0.75 percent.

The WB charges LIBOR+1.65 percent (maximum) for the IDA (SUF) loan, with a five-year grace period and 0 to 0.5 percent commitment charges (currently set at zero percent). The repayment schedule (maturity period) of the loan is 25 years (including 5 years grace period). For the IBRD loan, it charges LIBOR+1.65 percent (maximum), with a five-year grace period and 0 to 0.5 percent commitment charges. The repayment schedule (maturity period) of the loan is 30 years.

The Germany-KfW lending interest rate is 0.75 percent, with a grace period of six years. The loan has commitment charges of 0.25 percent, and its maturity period is 38 years. For the penalty, if not paid on time, the KfW may increase the rate of interest on arrears to the base rate plus three percent per annum for the period beginning with the assigned due date.

Source: Pro Pakistani