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Great call bro! Huge! Here is the News = Trinity Biotech Announces Q3 2023 Financial Results & Business Update
-Investor call to be held today at 8:30 am EST
DUBLIN, Ireland, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) today announced the Company’s results for the quarter ended September 30, 2023.
Business Updates and Strategic Priorities
In December 2023, the Company announced the promotion of John Gillard from CFO to CEO and the promotion of Des Fitzgerald to the role of Interim CFO. The new management team has now put in place a clear set of strategies and priorities as set out below.
Biosensor technology acquisition
The Company has today announced the acquisition of the biosensor assets of Waveform Technologies Inc. (“Waveform”) for $12.5 million in cash and 9 million American Depositary Shares (“ADS”) plus contingent consideration.
Driven by this transaction, the Company intends to use its newly acquired biosensor platform to build a range of wearable biosensors together with an analytical engine that can deliver useful and actionable health & wellness insights based upon what is happening in, on and around the body.
We will begin that journey by launching a next generation Continuous Glucose Monitoring (“CGM”) device with an “engineered in” lower cost of care when compared with the current main CGM market participants.
We believe that this can be a business of true scale and significant profitability. Further details of this transaction and our plans can be found here.
The Company also today announced it has entered into a non-binding Letter of Intent with Bayer for a joint partnership to launch a CGM biosensor device into China and India – further details can be found here.
Revenue growth and cash generation from our rapid HIV business
We are working to scale and optimise our rapid HIV testing manufacturing capacity in light of the successful launch of our TrinScreen HIV product in Kenya.
As previously announced, in December 2023 we began shipments of our HIV screening test, TrinScreen, to Kenya as part of the receipt of an initial purchase order for 2.5 million tests. We expect to receive additional orders throughout FY2024 for Kenya, as the Kenyan Ministry of Health has received commitments from all relevant sponsors (including Global Fund and USAID) to fund the procurement from the Company of at least 10 million rapid screening HIV tests required by Kenya for 2024.
The additional volumes arising from these orders is expected to at least triple our annual rapid HIV test manufacturing volumes in 2024 compared to 2023. These additional volumes should commercially facilitate us changing the location of certain aspects of our manufacturing process of our rapid HIV products Uni-Gold and TrinScreen. We expect significant margin, EBITDA and cash flow generation accretion benefits from this manufacturing location change, which we plan to have in place by the end of 2024.
Optimization of our Diabetes business to help meet growth and profitability goals
We aim to significantly improve the cost structure of our existing Diabetes HbA1c testing business, which we expect will improve the profitability, cash generation and ultimately the value of that business.
These initiatives should facilitate a lower price point solution into the Diabetes HbA1c testing market which we expect will deliver renewed growth from our Premier 9210 system, which continues to be widely regarded as the gold standard for interference-free Diabetes HbA1c testing globally. As a management team, we are focused on the execution of the following initiatives, which we believe will allow us to successfully meet our growth and profitability goals for our Diabetes HbA1c business: In-house manufacturing process: Our revised in-house manufacturing process of our key Diabetes HbA1c consumable began in Q4 2023 as planned, and we expect to end external production by the end of Q1 2024.Launch of the Improved Column System: Our programme to develop an improved, backward compatible column system is expected to be completed in the coming weeks with a subsequent commercial launch in Q2, 2024.Supply Chain Optimisation: We continue to optimise our supply chain for our Diabetes HbA1c testing instrument. In Q4 2023 and so far in Q1 2024 we have secured additional savings and we remain on target to deliver a lower cost of instrument which supports our strategy of driving renewed growth by increasing the competitive positioning of our product.We remain on track to deliver approximately $4m of annualised recurring cost savings from these initiatives, based on expected production volumes, and we believe that these changes will allow us to deliver an increasingly cost competitive Diabetes HbA1c solution, putting us in a stronger position to grow market share over time.We also continue to critically examine other aspects of the manufacturing structure of our overall Haemoglobins business with a view to further reducing the cost of operations.
Optimise the value of our other businesses
We are seeking ways to identify the most value accretive use for our other smaller businesses. We have engaged external consultants to support our examination of the optimal path to value accretion for these businesses, with each business being examined across the following criteria: Its ability to scale in a meaningful manner.Is there existing intellectual property or can we create new intellectual property that creates true points of differentiation to drive meaningful operating margin and cash generation.The identification of alternative uses for the assets and capabilities of each business.
These reviews remain ongoing, and we will update shareholders in due course as we solidify plans for these businesses.
Overall focus on improved profitability and revenue growth
Overlaying each of our business segments is a key focus on profitability through optimizing our revenue and cost cycles. In late Q4, 2023 we notified a large number of customers of pending price increases where contractual and commercial conditions allowed, reflecting significant input cost increases we incurred in 2023. We expect this to deliver margin accretion in late Q1, 2024 for some of our business lines. We also continue to be focused on reducing ongoing costs. In addition to the previously communicated headcount reductions, management executed on additional headcount reductions in early 2024 in senior management and back-office functions, as we continue to simplify and optimise our operations. Although financial benefits of our headcount reductions started to be realised in Q3, 2023, the full financial impact of these is expected to be seen in the first half of 2024, with an annualised cashflow saving of over $4m expected, excluding the incremental hiring for Trinscreen HIV and our new wearable biosensor business.
Amended Credit Agreement
Today the Company also announced it has entered into an amended credit agreement with its existing main lender, Perceptive Advisors (“Perceptive”) (the “Amended Term Loan”).
Under the Amended Term Loan, an additional $22 million of funding has been made available to the Company, with $12.5 million being used to acquire the Waveform assets. The remaining $9.5 million is available for general corporate purposes including for the further development of the CGM and biosensor technologies. In addition, the Amended Term Loan provides for additional liquidity of up to $6.5 million, that may be drawn down by the Company between April and December, 2024, and can be used for general corporate purposes, thereby providing further liquidity to fund the development of the CGM and biosensor technologies.
The Amended Term Loan immediately reduces the annual rate of interest on the loan by 2.5% to 8.75% (the “Base Rate”) plus the greater of (a) Term Secured Overnight Financing Rate (SOFR) or (b) 4.0% per annum and allows for a further 2.5% reduction in the Base Rate to 6.25% once the outstanding principal under the Amended Term Loan falls below $35 million. Additionally, the Amended Term Loan halves the early prepayment penalty from 8% to 4.0% and 7% to 3.5%, dependent on timing of prepayment. Furthermore, the Amended Term loan significantly reduces the Company’s revenue covenants which will enable the new management team to place increased focus on customer and product profitability, in line with its renewed focus on profitability. The Amended Term Loan matures in January 2026.
In connection with the Amended Term Loan, Perceptive will receive new warrants to purchase an additional 2.5 million ADSs and the Company has agreed to price these additional warrants and reprice the existing warrants to purchase 2.5 million ADSs that were issued to Perceptive under the original term loan, with an exercise price of $0.44 per ADS.
Q4 2023 Preliminary Unaudited Trading Update
We expect Q4, 2023 revenue to be between $13 million and $14 million with Gross Margin percentage expected to be broadly in line with the reported Gross Margin percentage for Q3, 2023.
We expect that Q4, 2023 revenues will be broadly in line with Q3, 2023 in the majority of our product lines, with expected reductions in our Haemoglobins and HIV businesses: Reported revenues from our Haemoglobins business are expected to be lower than Q3, 2023 as year-end shipments of products at sub-optimal pricing were deferred as we renegotiate contract terms with a key customer in line with the new management team’s focus on profitability.In our HIV business, shipments of Uni-Gold are expected to be lower than Q3, 2023 due to the typical irregular quarter on quarter ordering patterns in that business.
Third Quarter Results (Unaudited)
The results of the Fitzgerald Industries life sciences supply business, which was disposed of on April 27, 2023, have been reported separately as discontinued operations in the Consolidated Income Statements for all periods presented. In the Consolidated Balance Sheet at March 31, 2023, the assets and liabilities attributable to Fitzgerald Industries were separately presented within “Assets included in disposal group held for sale” and “Liabilities included in disposal group held for sale”. At June 30, 2023 and September 30, 2023, the assets and liabilities attributable to Fitzgerald Industries have been de-recognised from the Consolidated Balance Sheet.
Total revenues for Q3, 2023 were $14.7 million which compares to $15.7 million in Q3, 2022, a decrease of 6.5% and which were broken down as follows:
Table 1. Trinity Revenue Segments
2023
Quarter 3 2022
Quarter 3 Increase/
(decrease)
US$’000 US$’000 %
Clinical laboratory 11,981 13,168 (9.0 %)
Point-of-care 2,696 2,536 6.3 %
Total 14,677 15,704 (6.5 %)
Clinical laboratory revenues were $12.0 million, compared to $13.2 million in Q3, 2022, representing a decrease of $1.2 million or 9%.
This decrease in clinical laboratory revenues was primarily driven by lower lab services and autoimmune manufacturing revenue, which was down $1.1 million versus Q3, of 2022. As previously reported, in early 2023 we ceased transplant testing activity at our Buffalo, New York laboratory, which drove the majority of this decline. In addition, there was a reduction of just over $0.2 million in revenues from our COVID-19 VTM products and a reduction of $0.2 million in revenues from our Clinical Chemistry products when compared to Q3, 2022. These reductions were offset by an increase of $0.3 million within our Haemoglobins division as a result of increased sales of our consumables for our Premier 9210 product.
Point-of-care revenues for Q3, 2023 were $2.7 million, which was 6.3% higher than in Q3, 2022, due to higher sales of our HIV confirmatory test Uni-Gold during the quarter.
In Q3, 2023, gross profit was $4.3 million, equating to a gross margin of 29.2%, compared to a Q3, 2022 gross profit of $0.3 million equating to a gross margin of 2.1%. The lower gross margin in Q3, 2022 reflected excess inventory obsolescence charges of $4.7 million and excluding this charge, Gross Margin for Q3, 2022 would have been 32.0%.
In Q3, 2023 an excess inventory obsolescence charge of $0.9m was recognised, driven by a write down of COVID-19 VTM inventory of $0.6 million, as expected demand for that product did not materialise in Q4 2023 or the early part of 2024 and a further write down of inventory relating to our Tri-Stat instrument of $0.3 million as part of the sunsetting of that product line. Excluding these excess inventory obsolescence charges in Q3, 2023, Gross Margin would have been 35.5%, an increase of 350 basis points above Q3, 2022 Gross Margin analyzed on the same basis.
Other operating income of $70,000 for Q3, 2023, compared to $1,000 for the same period in 2022. This income relates to a transition services agreement with the acquirers of Fitzgerald Industries.
Research and development expenses of $1.2 million in Q3, 2023 increased from $1.0 million in Q3, 2022 mainly due to lower capitalization of payroll costs into product development intangible assets.
Selling, general and administrative (“SG&A”) expenses of $7.7 million increased by $2.5 million in Q3, 2023, compared to $5.2 million in Q3, 2022. The $2.5 million increase was primarily related to:
An elevated level of advisory and professional services costs which increased by $0.5 million,
Higher non-cash share-based compensation accounting charges of $0.6 million due to options granted since Q3, 2022,
Lower foreign exchange gains of $0.4 million, and
Restructuring costs of $0.2 million associated with our previously announced headcount reductions.
In Q3, 2023 our non-product development professional advisory, audit and consulting fees were approximately $1.0 million, which is higher than our expected future spend. This spend was mainly driven by a) higher legal and financial advisory transaction fees incurred as part of our acquisition of the biosensor assets of Waveform and b) external consulting fees incurred as we continue the examination of the optimal path to value accretion for some of our smaller business lines. Although we also expect an elevated level of advisory and professional fees in Q4 2023 driven by the same activities, these projects are time limited, and we expect our annualized non-product development professional advisory, audit and consulting fees expenses to be broadly half of that level per quarter through 2024, unless we engage in additional transactions.
Operating loss for the quarter was $4.5 million, compared to an operating loss of $8.1 million in Q3, 2022. The lower loss was due to an impairment charge recognised in Q3, 2022 of $2.3 million and higher excess inventory obsolescence charges in Q3, 2022 of $3.8 million when compared to Q3, 2023, partly offset by higher SG&A costs in Q3, 2023.
Financial income for Q3, 2023 was $0.4 million compared to $0.3 million for Q3, 2022 and related to fair value adjustments to warrants granted to the Group’s principal lender. Financial expenses in Q3, 2023 were $2.4 million compared to $2.2 million in Q3, 2022, an increase of $0.2 million, which was attributed to higher prevailing interest rates on the senior secured loan.
The loss after tax for continuing operations for the quarter was $6.7 million compared to a loss of $10.0 million for the comparable period last year. The variance is due to the impairment charge and excess inventory obsolescence charges in Q3, 2022, partly offset by higher SG&A costs in Q3, 2023.
Loss before interest, tax, depreciation, amortization and share option expense (EBITDASO) for continuing operations for Q3, 2023 was $3.5 million. This is broken out in more detail in Table 2 below.
Table 2. EBITDA and EBITDASO Calculation:
$m
Operating loss (4.5 )
Depreciation 0.2
Amortisation 0.1
EBITDA for continuing operations (4.2 )
Share option expense 0.7
EBITDASO for continuing operations (3.5 )
Note: table contains rounded numbers.
The basic loss per ADS for Q3, 2023 was $0.18 compared to a basic loss per ADS of $0.24 in Q3, 2022. Diluted loss per ADS is the same as basic loss per ADS for both current and comparative quarters.
Use of Non-IFRS Financial Measures
The attached summary unaudited financial statements were prepared in accordance with International Financial Reporting Standards (IFRS). To supplement the consolidated financial statements presented in accordance with IFRS, the Company presents non-IFRS presentations of, adjusted EBITDA and adjusted EBITDASO. The adjustments to the Company’s IFRS results are made with the intent of providing both management and investors a more complete understanding of the Company’s underlying operational results, trends, and performance. Non-IFRS financial measures mainly exclude, if and when applicable, the effect of share-based payments, excess inventory obsolescence charges, depreciation, amortization and impairment charges.
EBITDA for continuing operations and EBITDASO for continuing operations are presented to evaluate the Company's financial and operating results on a consistent basis from period to period. The Company also believes that these measures, when viewed in combination with the Company's financial results prepared in accordance with IFRS, provides useful information to investors to evaluate ongoing operating results and trends. EBITDA for continuing operations and EBITDASO for continuing operations, however, should not be considered as an alternative to operating income or net income for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. EBITDA for continuing operations and EBITDASO for continuing operations are not measures of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. Reconciliation between the Company's operating profit/(loss) and EBITDA for continuing operations and EBITDASO for continuing operations are presented.
Liquidity
The Group’s cash balance decreased from $14.2 million at the end of Q2, 2023 to $6.3 million at the end of Q3, 2023, a decrease of $7.9 million. Cash used by operating activities for Q3, 2023 was $4.7 million compared to $0.7 million generated in Q3, 2022, which was inclusive of a negative net working capital movement of $2.3 million. During Q3, 2023 the Company had investing cash outflows related to acquisitions of property, plant and equipment, product development and transaction costs of $0.9 million (Q3, 2022: $1.3 million) and payments for property leases of $0.6 million (Q3, 2022: $0.7 million). Interest payments in the quarter were $1.9 million (Q3, 2022: $1.7 million).
Conference Call
The Company will host a conference call on Wednesday, January 31 at 8:30 a.m. EST to discuss its recent Waveform acquisition and third quarter results. To access the call, please dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and use conference ID 13744109.
A live webcast and replay of the conference call is available at: https://viavid.webcasts.com/starthere.jsp?ei=1654009&tp_key=270fbd0272
Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe-harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterised by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this presentation may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on our purchase of the assets of Waveform, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2022 and Trinity Biotech’s other periodic reports filed from time to time with the United State
SINTX SUBSIDIARY TECHNOLOGY ASSESSMENT & TRANSFER TO DEVELOP 3D PRINTING AND CMCs WITH DEVCOM-ARMY RESEARCH LABORATORY
SALT LAKE CITY, Jan. 30, 2024 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (www.sintx.com) (NASDAQ: SINT; “SINTX” or the “Company”), a manufacturer and developer of advanced ceramic materials and related technologies, announced that its wholly owned subsidiary Technology Assessment & Transfer, Inc. (TA&T) has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Combat Capabilities Development Command Army Research Laboratory (DEVCOM ARL). This partnership is expected to leverage the strengths of both organizations in the areas of ceramic additive manufacturing (ceramic 3D printing) and ceramic matrix composites (CMCs).
According to its website, the U.S. Army DEVCOM Army Research Laboratory is the U.S. Army’s research laboratory strategically placed under the Army Futures Command. DEVCOM ARL is the Army’s sole foundational research laboratory focused on cutting-edge scientific discovery, technological innovation, and transitioning capabilities for the future Army (See: (https://arl.devcom.army.mil/).
SINTX’s Millersville, MD facility, Technology Assessment and Transfer, Inc., began work on ceramic 3D printing in the mid 1990’s, printing its first component in 1998. SINTX now provides prototype and Low-Rate Initial Production (LRIP) ceramic 3D printing services, sells ceramic-filled resins that customers use in their own printing processes, and works with multiple customers in the development of printing solutions for new materials.
In parallel to ceramic 3D printing, SINTX’s Maryland site has also been developing ultra-high temperature CMCs, and building extensive capabilities in the densification of fiber-based preforms using both chemical vapor infiltration and polymer infiltration and pyrolysis. SINTX is excited to participate in the dramatic increase in the market need for these materials in hypersonic vehicle applications as one example.
Ann Kutsch, General Manager of the Maryland site, commented: “We have a highly skilled team of engineers and technicians here in Maryland, all of whom are instrumental in pushing this cutting-edge work forward. I look forward to optimizing our offerings in these markets while also working with DEVCOM ARL to build both teams’ knowledge and capabilities in advanced technologies.”
Volume has tailed off from a couple of weeks ago. CEO takes 1 million dollars out of his pocket and buys at $0.94 is telling us we're gonna go big. I rarely average up but I did here lol
Nextimmune Inc (NASDAQ:NEXI) stock is up 170.2% to trade at $25.13, looking to extend its winning streak to three days as it stands at the top of the Nasdaq. Yesterday, NEXI added 73.8% following news that it expects its existing cash and cash equivalents to meet anticipated requirements through mid-February. Already in 2024, the stock is up more than 968%.
Cool. Hey, take a look at MRAI. All my DD is posted on the thread. Let me know your thoughts Tia.
Wow!!!! Thanks for sharing that info! Made me smile :))))
I can't,I have outstanding speeding tickets. As of November 1, 2023, the registrant had 1,058,125 shares of common stock, $0.0001 par value per share, outstanding.
I just bought more at $0.97 and I love the volatility. She will run as all the writing is on the wall. Patients are a must for great stocks.
Hey bro! Yeah, I know this Company very well and was a high flyer last summer. They had to do several PPs to get cash for the FDA and general funding for the Company. The powers behind the Company have the scientific knowledge to bring their men's health drugs to fruition. The key is they want men to be able to buy the meds without a prescription which will bring massive revenues. So the FDA requested 2 separate meetings with them in March. I think it's gonna be great news otherwise IMHO the FDA would have just shot them down in an instant. My speculation only.
WHOOPS!!!!!! Someone left the water running
I have read all of your posts here and it clearly makes perfect sense!
Hahahaha I'm jumping in LOL :)
As of October 31, 2023, the registrant had 13,050,007 ordinary shares, $0.01 par value per share, outstanding.
Still running on historical volume!
Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
Phase 3 REASSURE Trial Met Primary Endpoint of Non-Inferiority to Augmentin®; Demonstrated Statistical Superiority
Re-submission of NDA to FDA Expected in Q2 2024
Potential to be First Oral Penem Approved in the U.S.
Management to host a conference call at 8:30 a.m. ET today
DUBLIN and CHICAGO, Jan. 30, 2024 /PRNewswire/ -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced positive topline results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTIs).
"We are very pleased to announce positive data from this confirmatory trial, which was conducted under special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA)," said Corey Fishman, Iterum's Chief Executive Officer. "With the positive data from this trial, we plan to resubmit our New Drug Application (NDA) for oral sulopenem for the treatment of uUTI in the second quarter of 2024. At the same time, with these results in hand, we will be focusing on a strategic process to sell, license, or otherwise dispose of our rights to sulopenem with the goal of maximizing value for our stakeholders. We believe there is tremendous value in sulopenem as a potential new, oral antibiotic for the uUTI indication which has over 30 million infections annually in the U.S., rising resistance to all currently prescribed oral antibiotics, and a complete lack of new product innovation over the last 20 years."
Results demonstrate that oral sulopenem was non-inferior to Augmentin® with respect to the trial's primary endpoint, overall response (combined clinical cure plus microbiologic eradication) at the test-of-cure (TOC) visit in the microbiological-modified-intent-to-treat susceptible (m-MITTS) population. Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin®, demonstrating statistically significant superiority of oral sulopenem versus Augmentin®.
The table below summarizes the key efficacy data from the REASSURE trial at the TOC visit:
Sulopenem/probenecid500 mg/500 mgBIDN=480n (%)
Augmentin® (Amoxicillin/clavulanate)875 mg/125 mgBIDN=442n (%)
Treatment Differencei (95% CI)
Overall Responseii
296 (61.7)
243 (55.0)
6.7 (0.3, 13.0)
Clinical Successiii
371 (77.3)
339 (76.7)
0.6 (-4.8, 6.1)
Microbiological Successiv
361 (75.2)
295 (66.7)
8.5 (2.6, 14.3)
Difference in oral sulopenem versus Augmentin® in the m-MITTS population
[ii]
Combined clinical and microbiological success (primary endpoint)
[iii]
Clinical success at TOC = symptom resolution + no new uUTI symptoms
[iv]
Eradication of qualifying uropathogen to <103 CFU/mL at TOC visit
Both oral sulopenem and Augmentin® were well tolerated in this study with discontinuations due to adverse events occurring in <1% of patients on both regimens. No serious adverse events (SAE) were reported in patients receiving oral sulopenem, while five SAEs occurred in patients receiving Augmentin®, with no drug-related SAEs. The safety profile for oral sulopenem was consistent with those observed in each of the previously conducted Phase 3 trials, with no new safety signals noted beyond those associated with ß-lactams.
Iterum expects to present complete results from the REASSURE trial at an upcoming scientific meeting.
"In addition to achieving non-inferiority for the primary endpoint of overall response at the TOC visit in the Augmentin®-susceptible population in the REASSURE trial, the lower limit of the 95% confidence interval around the treatment difference was above zero, indicating statistical superiority of oral sulopenem over Augmentin® for the treatment of uUTI. Furthermore, consistent results were observed for all key secondary efficacy endpoints in this population," said Sailaja Puttagunta, M.D., Iterum's Chief Medical Officer. "These results bring us one step closer to delivering a much-needed oral treatment option for women suffering from uUTIs. In addition, we believe these results, along with evidence from our prior Phase 3 studies, support the potential of sulopenem in other indications, such as complicated urinary tract infections (cUTI)."
Iterum expects to resubmit its NDA for oral sulopenem to the FDA in the second quarter of 2024. Provided that the resubmitted NDA addresses all of the deficiencies identified in the Complete Response Letter (CRL) Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the fourth quarter of 2024).
Conference Call and Webcast Details
Iterum will host a conference call and webcast today, Tuesday, January 30, 2024, at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows:
United States: 1 833 470 1428 / International: 1 404 975 4839
Access code: 781689
The conference call will also be webcast live. The webcast can be accessed here.
About REASSURE
The REASSURE trial is designed as a non-inferiority (10% margin) trial comparing oral sulopenem and Augmentin® in the Augmentin®-susceptible population and is entitled "A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women." If the lower bound of the 95% CI is greater than -10%, non-inferiority of oral sulopenem over Augmentin would be concluded. If the lower bound of the 95% CI is greater than 0%, superiority of oral sulopenem over Augmentin would be concluded. Patients were randomized to receive either oral sulopenem twice daily for five days or Augmentin® twice daily for five days. The primary endpoint was the overall response (clinical and microbiologic combined response) at Day 12 (+/- 1 day) (TOC visit) of the trial. The trial enrolled 2,222 patients and is being conducted under a SPA agreement with the FDA.
About Urinary Tract Infections (UTIs)
UTIs are among the most common bacterial infections encountered in the community. There are approximately 15 million emergency room and office visits for symptoms of UTIs and over 30 million uUTIs treated in the United States annually, with approximately 30% of those infections caused by a quinolone non-susceptible organism, and approximately 1% of those infections caused by pathogens that are resistant to all commonly available classes of oral antibiotics. As a result, the treatment of UTIs has become more challenging because of the development of resistance by pathogens responsible for these infections. uUTIs are infections of the bladder occurring mainly in women. Half (50%) of all women experience at least one uUTI at some point in their lives.
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is currently advancing its first compound – sulopenem – a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem also has an IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, our ability to address the deficiencies set out in the complete response letter received in July 2021, the expected timing of resubmission of the NDA, the expected timing of review by the FDA and Iterum's strategic process to sell, license, or otherwise dispose of its rights to sulopenem. In some cases, forward-looking statements can be identified by words such as "may," "believes," "intends," "seeks," "anticipates," "plans," "estimates," "expects," "should," "assumes," "continues," "could," "would," "will," "future," "potential" or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, unce
Insane after-hours move on no NEWS up 100%
That is a nice find. I had stopped following MIMO and just saw that the shares have tripled in price during this month! Huge.
Bit of a after hours jump to $1.12
Maybe more to come. I hope so.
Yeah, man. A little better today. Thinking that some short coverings. Hope it continues
Caught some much-needed love today!
SOUNDS PROMISING ++++++++======= Petros Pharmaceuticals Announces Two Upcoming FDA Meetings to Review Progress and Path Forward for STENDRA(R) (avanafil) Rx-to-OTC Switch
FDA requests meeting to review the Company's technology component and discuss further development and requirements
NEW YORK, NY / ACCESSWIRE / January 24, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has scheduled two meetings with the U.S. Food and Drug Administration (FDA) to review the Company's progress and path forward in developing STENDRA as the first PDE-5 inhibitor approved as an over-the-counter medication for erectile dysfunction. (Please see Important Safety Information below.)
The Company has scheduled a Type C meeting with the FDA on March 26, 2024, to review the Company's developing digital app for use under the FDA's Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) proposed rule.[1] Primary topics of the meeting are expected to include how to continue the development of the app, protocols for upcoming studies, including the Summative Human Factors Study. In addition, the FDA has requested a listen-only meeting during the week of March 11th to review the app for improved productivity during the Type C meeting.
"We believe this meeting is significant and highlights the important progress that Petros has made as we work with the FDA in our quest towards achieving OTC status for STENDRA. It is particularly notable that the Agency has specifically asked for a listen-only meeting ahead of our Type C meeting, providing the opportunity for us to describe and demonstrate the app we are developing that will facilitate the self-selection process. We believe this step will be a differentiating factor relative to previous companies' attempts to bring their PDE-5 inhibitors OTC. We think these two meetings demonstrate the success of what we have achieved to date, that the Agency is taking an interest in the STENDRA nonprescription development program and continues its willingness to collaborate with us in the steps we need to take to potentially bring STENDRA over the counter," stated Fady Boctor, Petros's President and Chief Commercial Officer.
About Petros Pharmaceuticals
Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA, via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics.
About the OTC Pathway
The process of switching a prescription medication to over the counter (OTC) first involves the design of a Drug Facts Label (DFL) that is well understood by potential consumers. Then data must show that consumers can make an appropriate decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish these things, the FDA ordinarily requires a consumer tested OTC DFL. This testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting.
The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process.
Important Safety Information about STENDRA® (avanafil)
STENDRA® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. STENDRA® was designed and developed expressly for erectile dysfunction.
STENDRA is contraindicated with any form of organic nitrates, in patients with known hypersensitivity to any component of the tablet, and in patients who are using a guanylate cyclase stimulator.
Patients should not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason. Before taking STENDRA tell your doctor if you have had any kind of heart issues including heart attack, heart failure, angina and irregular heartbeat or have elevated or low blood pressure.
Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension.
Patients should seek emergency treatment if an erection lasts greater than 4 hours.
Patients should stop STENDRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss with patients the increased risk of NAION in patients with a history of NAION.
Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing.
STENDRA can potentiate the hypotensive effect of nitrates, alpha blockers, antihypertensives, and alcohol. CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase STENDRA exposure.
Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies is not recommended.
The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.
The use of STENDRA offers no protection against sexually transmitted diseases including HIV. Consider counseling
That would be fantastic! :)
Halted $1.24
Amazing news bro! Thanks!!! :)
ParaZero Achieved Positive Results from Mutual Project with Fortune 500 Automotive Manufacturer
ParaZero is furthering its collaboration with the same esteemed customer, having recently secured an additional order
Tel Aviv, Israel, Jan. 29, 2024 (GLOBE NEWSWIRE) -- ParaZero Technologies Ltd. (Nasdaq: PRZO) (the "Company “ParaZero”), an aerospace company focused on drone safety systems for commercial drones and urban air mobility aircraft, announced recently the successful completion of a significant drone safety project with a leading Fortune 500 automotive manufacturer (“the Customer”) for their proprietary drone program. As announced on December 20, 2023, and in line with the project agreement, ParaZero has received full payment for the development of a first-of-its-kind custom variant of their innovative SafeAir™ drone safety system.
This project involved the development and testing of a custom ParaZero SafeAir™ system designed and engineered to meet extremely demanding flight conditions and specifications to accommodate the Fortune 500 automotive manufacturer's proprietary aircraft program. This project was initiated from the design stage, ensuring an optimized and seamless integration on the aircraft, at unique flight envelope and operational characteristics. This project reinforces ParaZero’s reputation as a provider of advanced safety solutions across a myriad of aerial platforms, including multirotor, single rotor, fixed-wing, VTOL, manned and unmanned, and urban air mobility vehicles. Additionally, this project is a testament to ParaZero's capabilities to develop custom product variants to meet unique requirements and standards across a range of aircraft from around the world.
In addition to this achievement, ParaZero has received its second purchase order from the Customer in late 2023. This ongoing project further strengthens ParaZero's position as a leader in the aerospace industry, particularly in the development and integration of aircraft safety systems.
Boaz Shetzer, CEO of ParaZero, commented, “We are thrilled with the completion of this project, which showcases our robust technical capabilities and our commitment to delivering top-tier solutions in drone safety. The second order we have recently secured from this automotive company is a clear indication of the growing trust and demand in our specialized services.”
Surging after market hours. I looked for news but found nothing to support this major move. Any new info on your end? Tia
I don't blame you, bro! Have a relaxing weekend. Plenty more action on Monday ")
January 26, 2024
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Palisade Bio, Inc.
Request for Withdrawal of Registration Statement on Form S-1
File No. 333-276315
Ladies and Gentlemen:
On December 29, 2023, Palisade Bio, Inc. (the “Company”), a Delaware corporation, filed a Registration Statement on Form S-1 (File No. 333-276315) (together with the exhibits and supplements thereto, the “Registration Statement”) under the Securities Act of 1933, as amended (the “Securities Act”), with the Securities and Exchange Commission (the “Commission”) for the registration of the Company’s common shares in connection with its proposed public offering of securities. The Registration Statement has not been declared effective and no securities covered by the Registration Statement have been sold.
Pursuant to Rule 477 under the Securities Act, the Company hereby requests that the Commission consent to the withdrawal of the Registration Statement.
Pursuant to Rule 477(c) under the Securities Act, the Company advises the Commission that it may, upon consideration of its financing needs and options, undertake one or more subsequent private offerings in reliance on Rule 155(c) under the Securities Act.
In accordance with Rule 457(p) under the Securities Act, the Company requests that all fees paid to the Commission in connection with the filing of the Registration Statement be credited to the Company’s account to be offset against the filing fee for any future registration statement of the Company or an affiliate thereof.
If you have questions regarding this request, please contact the Company’s legal counsel, Raul Silvestre, Esq., of Silvestre Law Group, P.C., at +818-597-7552 or via email at rsilvestre@silvestrelaw.com. Thank you for your assistance with this matter.
Sincerely,
Palisade Bio, Inc.
That is there problem lol
That is a dangerous thing to do with a stock like this that is so unstable. You're lucky you covered it before it ran to 40.00 in the blink of an eye.
34.74 and halted
That is great technical info on your part. I bought a few yesterday @ $0.99 and might buy more now as this has a tiny float.
The number of shares outstanding of the registrant’s Common Stock as of November 13, 2023 was 2,046,308 shares.
Thank you again for your excellent survey on your DD
That is very interesting indeed. Thank you for the heads up 81vette
What did I tell you about those beings from another universe?
INSANITY RULES THE MARKET! tell you I miss the good ole OTC now dead in the water :(
INSANITY RULES THE MARKET! tell you I miss the good ole OTC now dead in the water :(
Just a bad month, it's all luck, all we do is speculate now we no longer have a real stock market of the past where mathematics = vision works. Now its just a throw of the dice. A worldwide game of Craps. I hear beings from another universe started this :)
Got its MOJO rising towards $3.00
$19.27 halted