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Will IPIX need to run another trial for variants??
True and Covid cases in Israel have gone down significantly as more of the population has been vaccinated.
ProMIS Neurosciences Completes US$7M (CDN$8.75M) Financing with Distinguished Group of Boston Based Investors
By Promis Neuro Admin on Mar 22, 2021 10:39 am
TORONTO, Ontario and CAMBRIDGE, Mass. — March 22, 2021— ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, is pleased to announce today the completion of an US$7M (CDN$8.75M) private placement of convertible unsecured debentures (the “Debentures“).
The investors include Mike Gordon of Fenway Sports Group, the Kraft Group, Henry McCance, co-founder of the Cure Alzheimer’s Fund, and Jeremy Sclar of WS Development Group. “After conducting diligence with a number of experts in the field, we are impressed with the tremendous potential of ProMIS Neurosciences and its unique platform of drug candidates to have a profound impact in the fight against Alzheimer’s and other neurodegenerative diseases. Our group is pleased to provide funding for the next phase of the company’s exciting future”, stated Mike Gordon of Fenway Sports Group.
“We are honored to have the support of such a distinguished group of investors, all of whom are accomplished leaders in the business and life sciences arenas” said Gene Williams, ProMIS Executive Chairman.
Debenture Terms
The Debentures are convertible into ProMIS common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum, which is payable annually. At the company’s election, accrued interest may be paid in cash or common shares (such number of shares determined by dividing the interest due by the 5-day volume-weighted average trading price or “VWAP” of the common shares).
The Debenture mature on March 22, 2026. Prior to the maturity date, the Company may force conversion of the Debentures at the conversion price upon raising US$50M in equity and/or debt cumulatively. On the maturity date, the Company may redeem the outstanding principal amount of the Debentures in either cash or common shares (at the then 5-day VWAP less a 10% discount) or a combination thereof at its election. Amounts redeemed in common shares on the Maturity Date will be subject to TSX acceptance.
The investors were granted a right to participate, on a pro rata basis, in subsequent company offerings of equity securities for cash consideration pursuant to a public offering or a private placement.
The Debentures and any common shares issued on conversion are subject to a four-month hold period that expires on July 22, 2021. Net proceeds will be used for working capital and general corporate purposes.
ProMIS plans to accelerate progress toward a number of top priorities, including:
Advancing the PMN310 monoclonal antibody, our potential “best in class” next generation Alzheimer’s treatment, into clinical testing;
Enhancing our partnering prospects for programs under active discussion by allowing us to invest in additional validation data;
Expanding our portfolio of products and intellectual property into new target areas, using our proprietary discovery platform;
Advancing our partnered diagnostic programs;
Achieving NASDAQ listing;
Expanding our Board of Directors; and
Expanding our management team, capitalizing on the talent pool in Boston, to support a growing and ambitious scope of activity.
Retirement of our CEO
Finally, a note of great appreciation for our CEO, Dr. Elliot Goldstein. Elliot, who just turned 70, has announced his intention to retire from a full time role by the end of 2021. Even though Elliot is irreplaceable, ProMIS has initiated a search for a new CEO to help us achieve our potential. “Elliot has been a close friend and valued business partner for decades,” said Gene Williams, “without his significant contributions, we would not have been able to take ProMIS from just a great science idea to a company with a growing portfolio of therapies that have the potential to be life-altering for patients. On behalf of the entire ProMIS community, and patients who in the future may benefit from our therapies, I offer Elliot our sincere thanks and gratitude”.
“ProMIS Neurosciences was launched six years ago based on a world class scientific platform from our CSO and scientific founder, Dr. Neil Cashman. Playing a key role in this endeavor has been one of the most challenging yet rewarding experiences of my 40 odd years in pharmaceutical drug development. I am delighted for this exciting new phase of the Company”, stated Dr. Elliot Goldstein, ProMIS CEO.
Why isn’t this at 50 cents ?
Reminds me of Prurisol.
50 cents is the new $1.00 dollar
Checks a lot of the boxes. FDA news not imminent but in very short order with June 2 meeting, which of course is just prior to the July 25/26 PDUFA date.
The company has PR’ed all of this.
Market cap currently is below where I think its true value is. This is going into the $2.00’s....then higher.
Iterum Therapeutics Appoints Beth P. Hecht to Board of Directors
Source: GlobeNewswire Inc.
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the appointment of Beth P. Hecht to the Company’s Board of Directors replacing Patrick Heron, who announced he would be leaving the Board, effective as of March 12, 2021. Ms. Hecht will also serve as a member of the Audit Committee and Compensation Committee of the Board.
“I want to thank Patrick for his leadership and steadfast support of Iterum since our founding in 2015. As the representative of one of Iterum’s founding venture capital firms, Patrick’s insights and experiences were invaluable in helping us build the solid foundation we now have,” said Corey Fishman, Iterum’s Chief Executive Officer.
Mr. Fishman continued, “I am very pleased to welcome Beth to the board at this important time for Iterum. Beth brings a wealth of extensive experiences from across the industry, and an in-depth understanding of commercial operations, regulatory, legal and compliance matters, as well as transactional experience that complements the expertise of our current board colleagues,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc. “As Iterum transitions from a development company to a commercial organization, we are looking forward to leveraging Beth’s diverse pharmaceutical experiences and collaborating with us to shape our strategic plans and advance our vision.”
“It’s an exciting time to join the Board of Iterum, and I’m looking forward to partnering with Iterum’s leadership as they work toward a bringing the first branded oral antibiotic for the treatment of uncomplicated urinary tract infections to the market in over 20 years, addressing a very important women’s health issue,” said Beth Hecht.
Ms. Hecht currently serves as Senior Vice President, General Counsel and Corporate Secretary of Xeris Pharmaceuticals, Inc. (NASDAQ: XERS). She has over 25 years of experience as a corporate executive in the life science industry, most recently serving as Managing Director and Chief Legal and Administrative Officer for Auven Therapeutics, a global biotechnology and pharmaceutical private equity firm. Ms. Hecht is also a member of the Board of Directors of Neos Therapeutics (Nasdaq: NEOS) where she chairs the Nominating and Governance Committee. Ms. Hecht is a graduate of Amherst College and Harvard Law School and started her career as an attorney specializing in intellectual property and corporate transactions at Willkie Farr & Gallagher (NY) and then Kirkland & Ellis (NY). She has established and led legal, compliance, licensing, human resources, and security departments at companies including Durata Therapeutics, Sun Products, MedPointe Inc. (formerly known as Carter-Wallace Inc.), Warner Chilcott PLC, ChiRex Ltd., and Alpharma Inc.
Your take on the trial or potential trial data?
Post of the day! Next RABBIT HOLE !!!
GlaxoSmithKline Plc and Vir Biotechnology Inc. said their Covid-19 antibody therapy showed a significant reduction of hospitalization and death for at-risk patients in an advanced-stage trial that progressed faster than expected.
The companies said Thursday that they will immediately seek emergency-use authorization in the U.S. after they finished a late-stage study early on the recommendation of an independent monitoring board. The treatment, VIR-7831, reduced the numbers of patients who were hospitalized or died by 85% compared to a placebo, the companies said.
New cases down significantly from their peak in the US.
Vaccine numbers keep increasing. Hurry Leo.
NDA accepted for priority review by FDA with PDUFA goal date of July 25, 2021: In January 2021, the FDA accepted for review our NDA for uUTI in patients with a quinolone non-susceptible organism. The FDA has designated our application as a priority review and consequently assigned a PDUFA goal date for completion of the review of oral sulopenem of July 25, 2021. The FDA currently plans to hold an advisory committee meeting to discuss the NDA on June 2, 2021.
Upcoming Investor Presentations
Corporate presentation at the Needham & Company 20th Annual Healthcare Virtual Conference from April 12-15, 2021
Corporate presentation at the RBC Capital Markets Global Healthcare Virtual Conference from May 18-19, 2021
The FDA currently plans to hold an advisory committee meeting to discuss the NDA on June 2, 2021.
Thank you. Hope for good results and the dilution will slow down.
Will the company release the trial results? If so when?
I still hope to see the Prurisol P2B trial results...anyone else?
Brilacidin competitor?
Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir
Save
March 6, 2021 12:01 am EST
The findings reported on a secondary objective to reduce time to negativity of infectious SARS-CoV-2 virus isolation from nasopharyngeal swabs from participants with symptomatic COVID-19
Primary and other secondary findings to be presented at an upcoming medical meeting
MIAMI & KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics, LP today announced preliminary results from Ridgeback’s Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral agent. The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. These preliminary findings were presented today during Science SpotlightsTM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005610/en/
This multi-center U.S. Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs. Periodic samples were collected for virologic analysis. Of the 182 participants with an evaluable nasopharyngeal swab, 42% (78/182) showed detectable levels of cultured virus at baseline. The full study results remain blinded and will be shared at a later date, as they become available. Other Phase 2 and Phase 2/3 studies are underway.
Today’s presentation described findings from the secondary endpoint of reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. At day 5, there was a reduction (nominal p=0.001, not controlled for multiplicity) in positive viral culture in subjects who received molnupiravir (all doses) compared to placebo: 0% (0/47) for molnupiravir and 24% (6/25) for placebo.
Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. In addition to the ongoing clinical studies, Merck has conducted a comprehensive nonclinical program to characterize the safety profile of molnupiravir. This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo. Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies. The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems.
“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”
“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising and if supported by additional studies, could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally,” noted Dr. William Fischer, lead investigator of the EIDD-2801 2003 study and Associate Professor of Medicine, Division of Pulmonary Diseases and Critical Care Medicine at the University of North Carolina School of Medicine.
“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
About Molnupiravir
Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally-bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.
About Merck
For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
PR released as the stock approaches .20
Interesting. Thanks for sharing.
If ITRM gets a deal similar to Cubist/Trius 700m plus and this could be around $5.00
Total disconnect, bio world, what has changed...nothing material IMO
FDA Approval will be a rocket PDUFA date set
Adding.
Getting choppy...waves getting taller and lower.
Will there be an announcement soon of a Kevetrin trial planned ? That’s a signal.
Undervalued.
That was a rather brief PR.
Good info Sox. New cases nationally are dropping significantly.
How about that. Wow.
10-Q Contingent Liability - Disputed Invoices
As described in Note 6. Accrued Salaries and Payroll Taxes, the Company accrued payroll to Dr. Krishna Menon, ex-President of Research of approximately $1,443,000 for his past services with the Company, and this amount was included in accrued salaries and payroll taxes. As described in Note 10. Related Party Transactions, the Company has a payable to KARD of approximately $1,486,000 for its research and development expenses and this amount was included in accounts payable. KARD is a company owned by Dr. Menon. Dr. Menon’s employment was terminated with the Company on September 18, 2018, and Dr. Menon resigned from the Company’s Board of Directors on December 11, 2018. Dr. Menon, on behalf of himself and KARD, demanded payment of these amounts in October 2019; however, the Company disputes the underlying basis for these amounts and notified Dr. Menon in November 2019 of the Company’s intent not to pay them.
All of the above disputed invoices were reflected as current liabilities as of December 31, 2020
Management need more time?
Has there been a fumble here? Little transparency
RSI bounce
One word...... Russia.
Good catch
8-k the CSO resigned. Probably getting a better gig somewhere else
Corey Fishman, Chief Executive Officer, will provide a company overview and business update at the following upcoming investor conferences:
SVB Leerink Annual Global Healthcare Conference: Thursday, February 25, 2021 at 3:00 pm ET
HC Wainwright Global Life Sciences Conference: on-demand beginning at 7:00 am ET on March 9, 2021
The company presentation may also be accessed by visiting the “Investors” section of the Company’s website under the “Events and Presentations” tab at www.iterumtx.com.
10-Q is out. Read away.