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Updates from the home page...
https://northerndynastyminerals.com/
Wondering if this type of new Toyota engine will become big competition for EV's,
or if it is another good but, failed idea in the end, and ENVX will emerge as the
the winner in all this technology.
rollup....great work rollup...greatly appreciated, all excellent news, and a reason to remain very hopeful. 😀
selected quotes from your link.........w the Indian Journal of Critical Care Medicine
"Effect of Aviptadil, a Novel Therapy, on Clinical Outcomes of Patients with Viral-related Severe ARDS:"
"Background: Dealing with life-threatening viral acute respiratory distress syndrome (ARDS) has always been challenging and with the recent COVID pandemic experience, there is still the need of newer therapies to alleviate mortality. Aviptadil, has shown significant beneficial results in COVID. We share our experience with this molecule by doing a retrospective study to evaluate the effect of this drug on clinical outcomes in viral-related ARDS patients."
"Conclusion: Aviptadil has shown to improve the clinical outcomes in patients with severe viral-related ARDS without any adverse effects"
Any old figures for the global dollar value of ARDS medications out there.. ???
Pegs, ...very sympathetic about your interstitial lung issues. Hopes and prayers for big improvements in the new year. The progress with aviptadil is disappointing for me at this time. ... I have hoped there will be some much better progress with big pharma in india or japan or especially a swiss company. Still hoping for a better 2024....
Interesting company in solid state battery tech is ENVX fyi
MONY....that sounds great,
appreciate the info ....but do you have a link for that. TIA
would like the go all in on ENVX, but I have been burned too many times, so
any links would be greatly appreciated.
https://oilprice.com/Energy/Energy-General/Toyotas-Solid-State-Battery-Boasts-745-Miles-On-A-10-Minute-Charge.html
Will or is ENVX be in this ballpark.?? Does not look like Toyota will be using ENVX, so gotta ask who.
Re Music... What type of compensation you think we could get?
I had a significant position, for me, in the lower 5 figures, with Barrick Gold a number of years back, easily over 10 years ago...
Barrick got sued similiarly.. I had lost a bunch of dinero...........It took a lot of work to put together all the trades and data required for the suit....
Then it took YEARS for a judgement.....Always thought it would be a nice payoff from the suit...
I finally wound up with a check for less than $20 bucks in a final settlement.... It wasnt even worth the time to put all the paperwork bull sheet together.. The lawyers are the only ones that make any money. Plain and Simple. Maybe some huge Fund Accounts get a few bucks.
Sadly no one likes to take a loss, but if anyone thinks this suit will amount to a big jackpot they are delusional IMHO. Lawyers file suits all the time against wall street stocks
https://www.zerohedge.com/commodities/copper-critical-americas-new-energy-economy
Anyone know a company that has incredible large vast amounts of copper waiting to be mined for developing a new energy grid and powering EV production. ?
I bet plenty of countries would like to have an asset like that.
Maybe we can import copper from China eh ?
Relief Therapeutics Announces that more than 400,000 of its ADRs are Currently Outstanding and that, as a Result, the Company has Achieved an Important NASDAQ Initial Listing Milestone
https://finance.yahoo.com/news/relief-therapeutics-announces-more-400-052000953.html
GENEVA, SWITZERLAND / ACCESSWIRE / October 10, 2023 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced that over 400,000 of its ADRs are now outstanding. Since one of the key requirements for a NASDAQ listing of ADRs is the requirement that a company have more than 400,000 ADRs outstanding at the time of its initial listing, this important milestone has now been achieved. If Relief is successful in listing its ADRs on the NASDAQ Stock Market, Relief's ADR listing will complement the existing listing of its ordinary shares on the SIX Swiss Exchange.
Relief Therapeutics Holdings AG, Friday, May 26, 2023, Press release picture
Relief Therapeutics Holdings AG, Friday, May 26, 2023, Press release picture
"We are pleased that our shareholders have contributed ordinary shares in return for ADRs in an effort to aid in our objective of listing our ADRs on a U.S. national securities exchange," said Jack Weinstein, chief executive officer of Relief. "Once the remaining requirements for listing are met, which primarily includes achieving a market price of $4.00 per ADR, we intend to progress quickly towards a NASDAQ listing of our ADRs." Mr. Weinstein continued, "Achieving a listing of our ADRs on a U.S. national exchange will broaden the pool of institutional investors able to invest both with open market purchases of our ADRs and in potential future U.S. offerings. We believe that Relief can obtain a NASDAQ listing status by the end of this year, and we are currently exploring several avenues to meet the remaining NASDAQ initial listing requirements."
https://quotes.freerealtime.com/quotes/RLFTF/Time%26Sales
safe and effective.......mgmt needs to to broadcast the message... looks like a
new round of covid being mfg.
Up, up on nice volume today.
Is good news on the way ?
Up over 8 percent today on no news and low volume.
Any one with any info ??
thanks for the update....
attached is a link.......a change is coming for NAK at some point in time.
This is a unusual rare UNANIMOUS start.
https://www.msn.com/en-us/news/politics/supreme-court-delivers-blow-to-key-biden-environmental-policy-in-unanimous-ruling/ar-AA1bGPIM
Thank you PW. Thats very helpful.
Now if Relief will only help with some block buster good news.
And at the end of an extensive and exhaustive appeals process, with gold over
$7500 per oz and momentum to push it over $10,000 per oz, the US dollar
in grave peril, along with the US in desperate need of strategic materials, their
emerges an different attitude about approvals for NAK.
..........Down the road...... at some point no doubt.....ying and yang. .
It might then be too late to buy in at a decent price. ....
Additional news........
https://finance.yahoo.com/news/relief-therapeutics-announces-swissmedic-approval-053000247.html
Relief Therapeutics Announces Swissmedic Approval and Operation of New Good Manufacturing Practice-Compliant Laboratory
The state-of-the-art quality control and research and development laboratory in Balerna, Switzerland is run by APR Applied Pharma Research SA, a Relief Therapeutics subsidiary
GENEVA, SWITZERLAND / ACCESSWIRE / May 15, 2023 / RELIEF THERAPEUTICS Holding SA (SIX: RLF)(OTCQB:RLFFD)(OTCQB:RLFTD) (Relief Therapeutics, or the Company), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced its new state-of-the-art laboratory has been audited and approved by the Swiss Agency for Therapeutic Products (Swissmedic) and meets Good Manufacturing Practice (GMP) standards. Swissmedic is the national authorization and supervisory authority for drugs and medical products and devices.
The next-generation laboratory in Balerna, Switzerland is run by Relief Therapeutics' subsidiary APR Applied Pharma Research SA (APR) and offers a comprehensive suite of analytical and development services for internal projects and provides external clients with data and full documentation to meet current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and international regulatory authority requirements.
"GMP compliance is a critical achievement for our laboratory, enabling us to create, safeguard and supply high-quality products to patients and healthcare providers as well as enable the future submissions of product files to regulatory authorities," said Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR. "Our new GMP lab is designed to meet forthcoming pharmaceutical challenges and is fully integrated with the current technical and analytical R&D capabilities, with more than 800 m 2 equipped for analytical and formulation development of solid and non-solid dosage forms."
The modern analytical laboratory is part of APR's overall upgrade of the research and development facilities and equipment in Balerna, which now includes four new state-of-the-art high performance liquid chromatography (HPLC) systems equipped for method scouting, new analytical scales, viscometers, physical testing instruments as well as a new packaging area equipped with filling and blistering machines to pack research and development prototypes for stability studies.
"We are excited that our new GMP-compliant lab in Balerna, where innovation is driven by our experienced and highly talented employees, is now Swissmedic-approved and operational," said Jack Weinstein, chief executive officer of Relief Therapeutics. "APR is a trusted and experienced formulator and developer, which has been validated by the breadth and quality of its contract service partners and products that have been developed over more than 30 years."
....Oddly, IMHO, I would think that RFL would want this on their web site....if only in reference to APR ....... any explaination ?
Yes, its getting pretty stale. Or some of the existing long term holders are bailing. Really at a point where some great news would go a long way.
Need the mgmt / office holders to buy in here. That would be a huge statement for all the shareholders as would be some very positive news.
Thanks PW.
IMHO....Relief needs to make some deals with some companies in counties like Switzerland, India and or Japan.
Any Approvals for ARDS would be huge......Whats the hold up ?
I wonder why some of the approvals by India can not be combined with Relief in order to market to other parts of the globe without the US involvement.
Further, I always thought that a RS would allow the big fund companies to buy in but so far its not looking that way. .
.
Right now is seems even the ticker symbols are a bit fuzzy to me.....
Seems to me this news would have made RLF a big mover
a year and a half back. I sort of think RLF needs some approvals for ARDS, C 19, etc, or team up with another company or country, like Japan, Korea, India, or a BP Swiss company
like Roche or Novartis.
.
Relief Therapeutics Announces Positive 12-Month Stability Data for Inhaled and Intravenous Preparations of RLF-100
Relief Therapeutics Holding SA / Key word(s): Research Update
17-Apr-2023 / 07:00 CET/CEST
GENEVA (April 17, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief Therapeutics, or Relief), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced positive 12-month stability data for the liquid and lyophilized preparations of RLF-100®, intended for intravenous (IV) and inhaled administration. RLF-100® is the company’s proprietary, investigational formulation of aviptadil acetate.
The data from the stability study showed that both inhaled and IV RLF-100® demonstrated high purity levels at 12 months at all temperatures tested, including refrigerated and room temperature environments. The results are consistent with prior data observed at three- and six-month intervals. The stability testing study will continue to determine the maximum shelf life of RLF-100®.
Based on the latest results, Relief Therapeutics intends to amend its previously filed provisional patent application for RLF-100® with the new findings. If granted, this patent could provide exclusivity for RLF-100® at least until 2042, without considering Hatch-Waxman extensions or other patent term adjustments. The Hatch-Waxman Act permits a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process.
“The testing conducted to date has consistently shown that our novel, optimized composition of aviptadil acetate provides better stability results in both the liquid and lyophilized preparations. RLF-100® was shown to be shelf stable and active after one year at temperatures suitable for shipping and long-term storage. This is an important milestone toward commercialization to ensure that RLF-100® is safe and effective, no matter where in the world it is supplied.” said Jack Weinstein, chief executive officer at Relief Therapeutics. “We believe this new, stable formulation has significant clinical and commercial value and our goal is to establish RLF-100® as the standard of care for the prevention and treatment of respiratory failure and its complications in both the acute and chronic applications.”
Stability testing of pharmaceutical products is mandatory for regulatory approvals. If a product fails to meet the standards prescribed by regulatory authorities, the product will not be granted approval for commercialization. Planning, execution and completion of studies in given timelines plays a major role in securing approval and ensuring a product reaches patients who need it.
RLF-100® is under development for the potential treatment of acute and chronic lung diseases, including pulmonary sarcoidosis, infectious acute respiratory distress syndrome (ARDS), checkpoint inhibitor-induced pneumonitis (CIP) and chronic berylliosis. The U.S. Food and Drug Administration (FDA) granted RLF-100® Orphan Drug designation (ODD) to inhaled RLF-100® for the potential treatment of pulmonary sarcoidosis in August 2021.
https://www.relieftherapeutics.com/newsblog-detail/?newsID=2490653
Bullish Long Term........
As prices climb higher and higher......Nak will become impossible to ignore.
https://www.zerohedge.com/markets/ppi-plunge-prompts-panic-bid-big-tech-bullion-bitcoin
https://twitter.com/search?q=Relief%20Therapeutics&src=typed_query&f=live
GENEVA, SWITZERLAND / ACCESSWIRE / April 5, 2023 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief Therapeutics" or the "Company"), a biopharmaceutical company committed to advancing treatment paradigms to benefit the lives of patients living with rare diseases, today announced that Nermeen Varawalla, M.D., Ph.D., chief medical officer, will depart the Company in the second quarter of 2023 to pursue other opportunities. The medical affairs team will report to Paolo Galfetti, chief operating officer at Relief Therapeutics, until a replacement is hired. Clinical development and regulatory responsibilities will continue to be supported by consultants already contracted with the Company.
"We have established strong medical affairs and research and development teams that will continue to serve us well as we focus our resources to advance our metabolic, connective tissue and pulmonary rare disease programs forward," said Jack Weinstein, chief executive officer at Relief Therapeutics. "We have moved our pipeline through several important milestones over the past year, and we appreciate Nermeen's contributions to those efforts. We wish Nermeen success in her future endeavors."
RT Appoints World-Renowned Gene Therapy Pioneer Guangping Gao, Ph.D. as Chair of Scientific Advisory Board
https://www.relieftherapeutics.com/newsblog-detail/?newsID=2482011
GENEVA, APRIL 3, 2023 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief Therapeutics" or the "Company"), a biopharmaceutical company committed to advancing treatment paradigms to benefit the lives of patients living with rare diseases, today announces the appointment of world-renowned gene therapy pioneer Guangping Gao, Ph.D. as the chair of the Company’s newly formed scientific advisory board (SAB). Dr. Gao is the co-director of the Li Weibo Institute for Rare Diseases Research, director of the Horae Gene Therapy Center and Viral Vector Core, professor of microbiology and physiological systems, and Penelope Booth Rockwell Chair in biomedical research at the University of Massachusetts Chan Medical School in Worcester, Mass.
Internationally recognized in the field of gene therapy, Dr. Gao played a key role in the discovery and characterization of a new family of adeno-associated virus (AAV) serotypes, which was instrumental in reviving the gene therapy field, significantly impacting many currently untreatable human diseases.
“Dr. Gao is a distinguished and accomplished academic and genetic medicine leader who has made fundamental discoveries in gene therapy that have pushed the field forward. He brings an unparalleled combination of pioneering scientific research and pre-clinical and clinical gene therapy product development expertise, along with advanced viral vector manufacturing experience,” said Serene Forte, Ph.D., MPH, senior vice president, head of genetic medicine at Relief Therapeutics. “It will be a privilege to work with Dr. Gao and benefit from his vast knowledge and advice in this space.”
In his advisory role, Dr. Gao will serve as an integral resource, providing scientific review and high-level technical and strategic guidance related to gene therapy targets, research and pre-clinical development and strategic research alliances as the Company works to expand its portfolio.
“The Relief Therapeutics team has built a strong foundation with their current portfolio and cost-effective capital approach to drug development,” said Dr. Gao. “I look forward to working with Dr. Forte and the highly capable leadership team to help build and proficiently execute the Relief Therapeutics genetic medicine program.”
Relief Therapeutics launched its genetic medicines initiative with the objective of developing life-altering, potentially curative therapies for patients suffering from devastating rare diseases that currently lack treatment options. The company is leveraging its strength and experience to identify monogenic disorders in therapeutic areas that align with its areas of focus, such as rare metabolic diseases. The SAB will support the Company’s genetic medicines initiative and additional appointments are forthcoming. To learn more about Relief Therapeutics’ approach to genetic medicine, please visit: https://www.relieftherapeutics.com/genetic-medicine.
“Dr. Gao’s extensive experience in the advancement of novel approaches to treat inherited rare diseases will be instrumental in helping us shape the direction of our genetic medicine portfolio,” said Jack Weinstein, chief executive officer at Relief Therapeutics. “We are honored to have Dr. Gao lead our new SAB and welcome him to Relief Therapeutic
wordman....thanks for posting ..............
Detail description.
Aviptadil was shown to restore barrier function at the endothelial/alveolar interface and to protect the lung and other organs from failure. In Europe, Aviptadil is approved for human use and has been shown to be safe in phase II trials for sarcoidosis, pulmonary fibrosis, bronchospasm, erectile dysfunction as well as in a phase I trial in ARDS in the past two decades. In the US, VIP has been given FDA Orphan Drug Designation for the treatment of ARDS and was admitted to the FDA Corona Virus Technology Accelerator Program.
In a phase I trial of Aviptadil performed by Sami Said in the early 2000s, eight patients with severe ARDS on mechanical ventilation were treated with ascending doses of intravenous VIP. Seven patients (88%) were successfully extubated and were alive at the five day time point. Six (75%) left the hospital and one (13%) died of an unrelated cardiac event. A phase II clinical trial using intravenous Aviptadil in patients with COVID-19 infection and ARDS has begun. Further, a phase II/III clinical trial will study the effect of inhaled Aviptadil for the treatment of non-acute lung injury in COVID- 19 and begins in June 2020. In Europe, two phase II trials of Aviptadil have been conducted. Further, studies with healthy volunteers have shown that inhaled Aviptadil is well tolerated with few adverse effects.
Thanks, Great Link panton.
Seems for a biotech, only a few times sales is pretty minimal, and
thats another reason to consider a substantial percentage increase in the longer run.
And with covid and all the other possibilities......tremendous potential.
A safe effective wonder drug, IMHO.
Excellent, excellent News, thanks Panton for the info on the RLF cancer med TD 011.
With a north american market value projected at over half a billion by 2028, it might be interesting
to speculate on the GLOBAL market value at that time or for this year. .
And thats not to mention other potential cancer applications for Relief Therapeutics.
Please refresh my thoughts on market value projections for CIP, ARDS or Sarcoidosis.
Thanks PW. Also....things are progressing as can be viewed in the link.
Never as quickly as I would like however. :)
https://www.relieftherapeutics.com/pipeline
G....you say you have moved on..
Obviously you have not.
You are still back here, and have NOT moved on and have NOT accepted your losses.
Good Luck. I hope you "move on" like you claim.
A worthwhile source of info on occasion.
https://twitter.com/search?q=Relief%20Therapeutics&src=typed_query&f=live
Thanks for all that post and share.
PW....After talking to several brokers at one of my accounts, it seems they have little information about the up coming 200 for 1 reverse split.
Do you have any info you could update us on as far as time frames and or costs to move into the new stock on the nazdaq. ? TIA.
PW.... thank you for all the info and posting the same.
Many Thanks to Bob and panton for sharing...... and all others also.
This link from Bert-Jan two days ago and on another board.
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06723-w
Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial
Abstract
Background
Despite the fast establishment of new therapeutic agents in the management of COVID-19 and large-scale vaccination campaigns since the beginning of the SARS-CoV-2 pandemic in early 2020, severe disease courses still represent a threat, especially to patients with risk factors. This indicates the need for alternative strategies to prevent respiratory complications like acute respiratory distress syndrome (ARDS) associated with COVID-19. Aviptadil, a synthetic form of human vasoactive intestinal peptide, might be beneficial for COVID-19 patients at high risk of developing ARDS because of its ability to influence the regulation of exaggerated pro-inflammatory proteins and orchestrate the lung homeostasis. Aviptadil has recently been shown to considerably improve the prognosis of ARDS in COVID-19 when applied intravenously. An inhaled application of aviptadil has the advantages of achieving a higher concentration in the lung tissue, fast onset of activity, avoiding the hepatic first-pass metabolism, and the reduction of adverse effects. The overall objective of this project is to assess the efficacy and safety of inhaled aviptadil in patients hospitalized for COVID-19 at high risk of developing ARDS.
Methods
This multicenter, placebo-controlled, double-blinded, randomized trial with 132 adult patients hospitalized for COVID-19 and at high risk for ARDS (adapted early acute lung injury score = 2 points) is conducted in five public hospitals in Europe. Key exclusion criteria are mechanical ventilation at baseline, need for intensive care at baseline, and severe hemodynamic instability. Patients are randomly allocated to either inhale 67 µg aviptadil or normal saline (three times a day for 10 days), in addition to standard care, stratified by center. The primary endpoint is time from hospitalization to clinical improvement, defined as either hospital discharge, or improvement of at least two levels on the nine-level scale for clinical status suggested by the World Health Organization.
Discussion
Treatment strategies for COVID-19 are still limited. In the context of upcoming new variants of SARS-CoV-2 and possible inefficacy of the available vaccines and antibody therapies, the investigation of alternative therapy options plays a crucial role in decreasing associated mortality and improving prognosis. Due to its unique immunomodulating properties also targeting the SARS-CoV-2 pathways, inhaled aviptadil may have the potential to prevent ARDS in COVID-19.
And too much more to post on here.... please follow the link
Hopefully the final results will be very favorable to RLF shareholders, with
a very considerable interest in the Neuro drug or significant monetary refunds.
>"On August 22, 2022, Relief announced that it has agreed to a tentative settlement of its pending litigation with NRx Pharmaceuticals and its subsidiary, NeuroRx, Inc. relating to Relief's September 2020 collaboration agreement with NeuroRx. The parties have agreed to work collaboratively to finalize the settlement within the next 30 days. Further, the parties have agreed to stay the litigation for an additional 60 days to allow for the negotiation and execution of the definitive settlement agreement and related terms. Terms of the settlement will be reported following execution of the definitive settlement terms. There can be no assurance that the settlement will be completed.<
Panton...lots to absorb here.... .Text of your link on artcle on Sept 15
GENEVA, SWITZERLAND / ACCESSWIRE / September 15, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), a Swiss, commercial-stage biopharmaceutical company seeking to provide patients therapeutic benefit from selected specialty, rare and ultra-rare diseases with high unmet need, today reported its results for the half-year ended June 30, 2022 and provided a corporate update.
Relief Therapeutics Holdings AG, Monday, September 12, 2022, Press release picture
Relief Therapeutics Holdings AG, Monday, September 12, 2022, Press release picture
"We achieved significant progress during the first half of 2022, continuing to execute on our goal of becoming a fully integrated, capital-efficient, commercial-stage biopharmaceutical company targeting rare and specialty disease indications. In particular, we have focused on preparations for the impending U.S. launch of PKU GOLIKE®, a differentiated medical food product engineered with the patent protected, proprietary Physiomimic drug delivery technology, for the dietary management of phenylketonuria ("PKU"), which is currently marketed in Europe, and we look forward to the U.S launch in the fourth quarter of this year, " stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. "The planned commercial introduction into the U.S. necessitated an expansion of our sales organization and commercial capabilities, and we were pleased to have appointed a number of highly seasoned biotech executives to lead this effort. These included Christopher Wick as Executive Director, Head of U.S. Sales; Drew Cronin-Fine, as Executive Director, Head of U.S. Marketing; and David McCullough, as Senior Director and Head of U.S. Market Access, all reporting to Anthony Kim, Senior Vice President, and Head of U.S. Commercial Operations. We also acquired from Meta Healthcare Ltd. the worldwide commercialization rights (except in the UK) for a novel dosage form of an already FDA-approved prescription drug, intended for the treatment of patients with PKU, adding to our offerings and solidifying our position in this market. We anticipate filing for registration approval through a 505(b)(2) NDA during 2023, further evidencing our cost-effective approach to drug development."
Dr. Selvaraju added, "Meanwhile, we continue to work closely with our partner, Acer Therapeutics Inc. ("Acer"), for a potential U.S. launch of ACER-001, a taste-masked, immediate-release, proprietary powder formulation of sodium phenylbutyrate (NaPB) to treat urea cycle disorders ("UCDs"). Acer resubmitted a New Drug Application ("NDA") to the FDA under the 505(b)(2) pathway for ACER-001 in UCDs in July 2022. The FDA accepted the NDA and assigned a Prescription Drug User Fee Act ("PDUFA") target action date of January 15, 2023. Assuming approval, we anticipate U.S. commercialization in the first half of 2023, marking an important milestone for the collaboration and representing our second commercialized product in the U.S. We also plan to submit a Marketing Authorization Application for approval of ACER-001 for the treatment of UCD in the U.K. and EU. Additionally, Acer submitted an Investigational New Drug ("IND") application to the FDA to evaluate the safety and efficacy of ACER-001 for the potential treatment of Maple Syrup Urine Disease ("MSUD"). We anticipate clinical studies to begin in the fourth quarter of 2022 and expect that data from these studies would be suitable for product registration in the U.S. and Europe. During the year, we also significantly strengthened the intellectual property portfolio of ACER-001 with receipt of patents covering methods-of-use claims for the potential treatment of UCDs and MSUD.
"We also made progress in our program targeting pulmonary diseases. Importantly, we announced promising three-month initial stability data on a new formulation of RLF-100®, which appears to be shelf-stable at temperatures suitable for shipping and long-term storage, thus, potentially having significant clinical and commercial value. We intend to continue to develop RLF-100® for a range of lung diseases. The inhaled formulation of RLF-100® is presently being evaluated in a European study for COVID-19-infected patients (the "Leuppi Study"), for which we expect to report top-line data sometime before year end 2022, subject to completion of patient enrollment. Additional indications include, pulmonary sarcoidosis, for which we have Orphan Drug Designation ("ODD"), and for which, during 2023 we plan to initiate a phase 2b dose-ranging study in 72 patients. We expect to schedule a pre-IND meeting with the FDA to confirm the efficacy and safety endpoints as well as the proposed dosing regimen and, based on a positive outcome, expect to begin this phase 2b study during 2023. We plan to also explore RLF-100® for checkpoint inhibitor-induced pneumonitis, for the treatment of non-COVID-19-related acute respiratory distress syndrome ("ARDS") and to conduct a European proof-of-concept of RLF-100® in the treatment of chronic berylliosis.
"In parallel to these activities, we continue to develop APR-TD011 for the treatment of epidermolysis bullosa ("EB"), for which we have received FDA ODD. Based on strong clinical results, GMP-grade pharmaceutical product is being prepared for clinical development under an FDA-authorized IND, with a clinical trial slated to start in the second quarter of 2023. Additionally, we will leverage our collaboration agreement with InveniAI LLC, a pioneer in the application of artificial intelligence which, we believe, will meaningfully complement our existing drug development expertise and generate numerous promising additions to our pipeline. We have also instituted an effort to pursue the inception and advancement of next-generation, disruptive genetic medicines, taking advantage of innovations in genetic technologies including gene therapy and genome editing to facilitate the development of potentially curative therapies for areas of high unmet medical need.
"Last year, we launched a Level 1 ADR program in the U.S. and are aggressively moving to a Level 3 ADR and an associated Nasdaq Stock Market listing, which we expect to occur in the fourth quarter of this year. To that end, on August 23, 2022, we filed an F-1 Registration Statement with the U.S. Securities and Exchange Commission to register our ADSs for sale in the United States. We ended June of 2022 with a solid cash position of CHF 29.9 million, providing a forecasted cash runway into the third quarter of 2023. We also expect that, with the launch of the PKU GOLIKE® franchise in the U.S. and a successful launch of ACER-001 in early 2023, Relief could achieve cash flow breakeven in late 2024 and positive operating cash flow in early 2025.
Today, we are a more mature, forward integrated, commercial-stage specialty drug company with a deep pipeline and multiple opportunities for growth and we will continue to actively pursue a strategy to diversify our pipeline and are continuously evaluating in-licensing and acquisition opportunities."
Key Clinical Development Highlights:
PKU GOLIKE®
In March 2022, APR Applied Pharma Research SA ("APR") announced that the International Journal of Molecular Sciences had published in vivo data on metabolic responses to formulations of amino acid mixtures for the treatment of PKU. The peer reviewed journal's paper indicated that prolonged release of amino acids, such as those present in formulations like PKU GOLIKE®, may have beneficial effects on the dietary treatment of PKU.
In April 2022, APR received a Notice of Allowance from the USPTO for Patent Application No. 15/303,121, entitled, "Modified Release Orally Administered Amino Acid Formulations." The allowance covers certain formulations of PKU GOLIKE® in APR's product line and supplements APR's PKU GOLIKE® intellectual property portfolio, which includes U.S. Patent No. 10,500,180.
ACER-001
In February 2022, Relief announced that Acer was issued U.S. patent 11,202,767 from the USPTO covering methods of use claims related to ACER-001's multi-particulate dosage formulation for oral administration for the potential treatment of UCD and MSUD. The patent builds upon previous issuance of U.S. patent 11,154,521, covering pharmaceutical composition claims of ACER-001.
In June 2022, Acer and Relief announced that the FDA had issued a Complete Response Letter ("CRL") regarding the New Drug Application ("NDA") for ACER-001 for UCD. The CRL stated that the FDA could not approve the NDA for ACER-001 for UCD in its current form due to an incomplete inspection of Acer's third-party contract packaging manufacturer. The FDA did not cite any other approvability issues in the CRL related to the NDA. Acer noted that it was actively working with its third-party contract packaging manufacturer and cooperating with the FDA to address the CRL and stated its intent to resubmit an updated NDA for ACER-001 for UCD in early-to-mid Q3 2022.
Subsequently, in July 2022, Relief announced that Acer had resubmitted its NDA for ACER-001 for the treatment of UCD to the FDA. Acer has advised Relief that the resubmission addressed, in full, the items raised by the FDA in the CRL. Later that same month, Relief and Acer announced the resubmitted NDA was accepted for review by the FDA, which designated the NDA as a Class 2 resubmission and set a PDUFA target action date of January 15, 2023.
In July 2022, Acer and Relief announced the submission of an IND application to the FDA to evaluate the efficacy and safety of ACER-001 for the potential treatment of MSUD.
In August 2022, Relief and Acer announced that the European Commission had granted orphan medicinal product designation in the EU to ACER-001 for the potential treatment of patients with MSUD.
APR-OD32
In March 2022, APR announced the acquisition of the worldwide commercial rights (excluding UK) from the UK-based company Meta Healthcare Ltd. ("Meta") for a novel, differentiated dosage form of a prescription drug already approved by the U.S. FDA and intended for the treatment of patients with PKU. This improved product is expected to enhance patient acceptance and compliance as well as enable easier, self or caregiver administered dosing and dispensing.
In July 2022, the final agreement was executed. Pursuant to the final agreement, Meta shall transfer to Relief all data, know-how, as well as any intellectual property related to "APR-OD32" as developed or generated by Meta. Relief shall only be responsible for funding the remaining development activities as well as for filing and obtaining a new drug application in all countries worldwide except for the UK where Relief shall grant a license back to Meta, enabling Meta to market the product in that country.
RLF-100® (aviptadil)
In April 2022, Relief reported that the Swiss Patent Office IPI issued a patent WO2020/225246 entitled, "Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis," to Relief's subsidiary, AdVita Lifescience GmbH ("AdVita"). The patent provides intellectual property protection to Relief's inhaled formulation of RLF-100® into at least 2039.
In May 2022, Relief provided a corporate update noting that it intends to continue clinical assessment of both inhaled and IV formulations of RLF-100® for pulmonary indications, including (1) the continuation of the European study of inhaled RLF-100® for COVID-19-infected patients (2) the initiation of a clinical trial of RLF-100® in early 2023 in patients with sarcoidosis (3) the exploration of RLF-100® for checkpoint inhibitor-induced pneumonitis (4) testing of RLF-100® in the treatment of non-COVID-19-related ARDS and (5) conducting a European proof-of-concept of RLF-100® in the treatment of chronic berylliosis.
Sentinox
In March 2022, APR Applied Pharma Research SA ("APR") reported final data from its clinical trial of Sentinox in SARS-CoV-2 infected patients. Although the primary endpoint was not achieved, the results suggest the potential efficacy of Sentinox, with a better response in subjects dosed 3 times per day versus the control group, in the reduction of the nasal viral load, negativization and infectivity and confirmed its safety and tolerability.
CAMBIA
In January 2022, APR received a Notice of Allowance from the USPTO for Patent Application No. 16/713,052 entitled, "Ready to Use Diclofenac Packs." Diclofenac potassium is an off-patent, potent non-steroidal anti-inflammatory drug ("NSAID") widely used therapeutically for inflammatory conditions and pain management.
Management and Board Additions
Relief expanded the Board of Directors with highly experienced life science industry executive Michelle Lock.
To match its fast pace of development, Relief has appointed seasoned executives to newly created roles including, Christopher Wick, as Executive Director, Head of U.S. Sales; Drew Cronin-Fine as Executive Director, Head of U.S. Marketing, and David McCullough as Senior Director and Head of U.S. Market Access.
Additionally, Relief appointed Serene Forte, Ph.D., MPH, to the newly created role of Senior Vice President, Head of Genetic Medicine, to spearhead Relief's new genetic medicine initiatives.
Business Update
On July 20, 2022, Relief's Registration Statement on Form 20-F under the Securities Exchange Act of 1934 became effective, and Relief is now a publicly reporting company in the United States.
In August 2022, Relief filed a Registration Statement on Form F-1 under the Securities Act of 1933 for a proposed offering of its ordinary shares in the form of American Depositary Shares ("ADSs"). The number of ADSs to be offered and the price range for the proposed offering have not yet been determined. As part of the registration process, Relief plans to apply to list its ADSs on the Nasdaq stock market, and such listing is expected to become effective on effectiveness of its registration statement. There can be no assurance that Relief's Form F-1 registration statement will become effective, that Relief will successfully complete an offering of its ADSs, or that Relief will be successful in its efforts to up-list its ADSs to the Nasdaq Stock Market. Any offering, if made, will only be made by an effective prospectus.
On August 22, 2022, Relief announced that it has agreed to a tentative settlement of its pending litigation with NRx Pharmaceuticals and its subsidiary, NeuroRx, Inc. relating to Relief's September 2020 collaboration agreement with NeuroRx. The parties have agreed to work collaboratively to finalize the settlement within the next 30 days. Further, the parties have agreed to stay the litigation for an additional 60 days to allow for the negotiation and execution of the definitive settlement agreement and related terms. Terms of the settlement will be reported following execution of the definitive settlement terms. There can be no assurance that the settlement will be completed.
Financial Highlights for the Six Months Ended June 30, 2022
Results of Operations
In the first six months of 2022, Relief generated CHF 3.24 million of revenue from product sales, licensing fees, and royalties. Prior to the business combination with APR at the end of June 2021, Relief did not generate any revenue.
Other gains were CHF 1.3 million for the six months ended June 2022, compared to CHF 0.9 million for the six months ended June 2021. In the current period, other gains consisted mainly of a change in the fair value of provisions for contingent liabilities and an impairment reversal following the repayment of a loan issued to NeuroRx in 2020 and for which Relief had recorded a complete impairment allowance. In the comparative period, other gains related to write-offs of liabilities.
External research and development expenses increased to CHF 10.6 million for the six-month period ended June 30, 2022, from CHF 8.3 million for the six months ended June 30, 2021, an increase of CHF 2.3 million primarily due to higher expenses incurred by Acer under the license and collaboration agreement and secondarily due to the addition of in-process programs through the acquisition of APR in June 2021. The increase in expenditures associated with ACER-001 and other in-process programs was partially offset by a reduction of CHF 5.7 million in development expenses associated with RLF-100.
Personnel expenses increased to CHF 5.8 million in the six-month period ended June 30, 2022, compared to CHF 3.4 million for the six-month period ended June 30, 2021, an increase of CHF 2.4 million mainly due to an increase in employee headcount resulting from the acquisitions of APR and AdVita and the establishment of our U.S. sales force. As of June 30, 2022, Relief had 57 full-time equivalents on its payroll.
Other administrative expenses increased to CHF 4 million in the six-month period ended June 30, 2022, compared to CHF 3.2 million for the six-month period ended June 30, 2021, an increase of CHF 0.8 million primarily attributable to expanded activities with the addition of APR and AdVita. Consulting expenses associated with the preparation of the market launch of PKU GOLIKE® in the U.S. further contributed to the increase. Legal fees remain flat as costs related to Relief's effort to become a publicly reporting company in the United States and to list its ADSs on Nasdaq were offset by a reduction in costs incurred for other legal and regulatory matters.
Relief conducted an impairment test of intangible assets as of June 30, 2022, and concluded that the carrying amount of certain assets, mainly intangible assets associated with PKU GOLIKE® and Sentinox™, exceeded their recoverable amount. As a result, the company recognized a non-cash impairment charge on intangible assets of CHF 8.2 million in the current period. The impairment charge reflects a reduction of estimated future net cash flows from PKU GOLIKE® following changes in market assumptions, and, for Sentinox™, a one-year delay in the estimated launch date.
Amortization and depreciation expenses were CHF 2 million for the six-month ended June 2022 and were nil for the six months ended June 2021. Prior to the acquisition of APR in June 2021, Relief did not have amortizable intangible assets nor material property, plant, and equipment assets on its balance sheet.
Financial expenses increased to CHF 1.1 million in the six-month period ended June 30, 2022, compared to CHF 0.3 million for the six-month period ended June 30, 2021, an increase of CHF 0.8 million primarily due to the recognition of an interest expense of CHF 0.7 million in relation with contingent liabilities that may become due upon achievement of milestones contractually agreed with the former shareholders of APR and AdVita.
Income taxes were a gain of CHF 1.6 million in the six months ended June 2022, compared to income tax expenses of CHF 0.01 million for the six-month period ended June 30, 2021. The income tax gain resulted mainly from the amortization of intangible assets and a corresponding reduction in the temporary difference between the carrying amount of these assets and their tax base.
Net loss for the period was CHF 26.5 million, compared to a net loss of CHF 14.7 million for the same period last year.
Relief's Half-Year 2022 Report, including the interim consolidated financial statements, is available for download here.
ABOUT RELIEF
Relief is a Swiss, commercial-stage, biopharmaceutical company focused on identification, development and commercialization of novel, patent protected products intended for the treatment of rare and ultra-rare diseases including metabolic disorders, pulmonary diseases and connective tissue disorders. Relief's diversified pipeline consists of assets that have the potential to effectively address significant unmet medical needs, including PKU GOLIKE®, engineered with the proprietary Physiomimic technology, which is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria ("PKU"). Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders ("UCDs") and Maple Syrup Urine Disease ("MSUD"). Relief also continues to develop aviptadil for several rare pulmonary indications. Further, Relief is in clinical development for APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa ("EB"), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA. Finally, Relief is commercializing several legacy products via licensing and distribution partners.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY.
For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Panton...Thanks for keeping us informed of the timely news articles.
Very much appreciated..
Deadlines are here .....Lotsa info here... and some fairy tales.
Thanks in large part to Wonger.......
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