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Heron Therapeutics Announces Partnership with CrossLink Life Sciences to Expand Promotional Effort for ZYNRELEF®, the First and Only Non-Opioid Dual Acting Local Anesthetic for Post-Operative Pain
SAN DIEGO, Jan. 7, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that it has entered into a five-year distributor partnership with CrossLink Life Sciences, LLC to expand the sales network supporting ZYNRELEF® (bupivacaine and meloxicam) extended-release solution.
The partnership will launch in several phases, initially at a regional level, followed by an expanded national rollout. In total, approximately 650 representatives will be added to Heron's sales network over the next year. CrossLink will be the lead partner in the United States to expand ZYNRELEF promotion for orthopedic indications. Under the terms of the agreement, CrossLink is compensated on a fixed-fee per vial basis, based on growth over a pre-determined baseline period.
"This partnership will allow Heron to expand access to this pain-reducing product for orthopedic surgery patients, allowing more accounts to adopt ZYNRELEF as an essential part of their surgical procedures," said Craig Collard, Chief Executive Officer of Heron. "CrossLink has a proven track record of success in building relationships, providing superior service to healthcare providers and improving patient outcomes. We look forward to kicking off a successful collaboration and further positioning Heron to deliver substantial value and impact patient lives in the coming years."
"We are excited about the partnership with Heron and its upcoming potential expansion of the ZYNRELEF label and the vial-access needle (VAN) which will streamline the product preparation. We have seen first-hand the impact that ZYNRELEF can have on post-operative pain, and our team is excited to deliver ZYNRELEF to more patients across the country," said Thomas Fleetwood, Chief Executive Officer of CrossLink.
CrossLink is the largest private orthopedic, spine and sports medicine device distributorship in the United States, consisting of experienced sales, operations and logistics teams driven by the foundational goal of improving patient outcomes. Over the past 45 years, its world class specialty sales organization and national network of distributors have become the market leaders in each of the regional markets they serve.
About ZYNRELEF for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication. In December 2022, we submitted an sNDA to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures. On July 31, 2023, the FDA notified Heron of an extension of the PDUFA approval goal date by three months to provide for a full review of the submission. The FDA has set a new extended PDUFA approval goal date of January 23, 2024. ZYNRELEF is now indicated in the U.S. in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.
Forward-looking Statements
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, uncertainties related to market conditions; the potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; the net product sales guidance for the oncology care franchise and the acute care franchise; the EBITDA guidance provided by the Company; the results of the commercial launch of APONVIE; the timing of the FDA's review process and whether the FDA approves the sNDA for ZYNRELEF to further expand the U.S. label; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF, if approved; the timing of the Company's development of the VAN program; the timing of the Company's submission of the PAS to the FDA for the VAN; the timing of the FDA's review process and whether the FDA approves the PAS for the VAN; the outcome of the Company's pending ANDA litigation related to CINVANTI; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; any inability or delay in achieving profitability; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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SOURCE Heron Therapeutics, Inc.
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Someone screwed me for 8k last month. Where I come from In New Jersey, we keep silent for a while and then without notice, we send out collectors that you don't wanna know. People mask themselves as being honest and then BOOM they stab you in the back. I have a story back in 2005 that will blow your mind. The worst evil exists in the stock market along with other places on this Earth
I was on a conference call this morning with a group of total Wall Mart ass wipes that wasted 45 minutes of my valuable time. I was pissed off for 15 minutes then went outside and had a cigarette and came back totally calm. The newbie, well maybe he didn't read my response so I'm not gonna rag him. We are dealing with people from all around this evil World and as you are well aware most are slime baskets with the mentality of a weasle. You and I along with a few other sweet people on Ihub have to look out for ourselves. This is our bread and butter.
Yeah, all is well bro, I'm adding another line of work in Feb. In Vegas. :)
Hey buddy! Happy New Year! CCCC looks fantastic even with the short sellers and the new offering. :)
Most likely because it began yesterday. https://www.otcmarkets.com/filing/html?id=17167586&guid=AxJ-k6p3ktlHJth
5 million dollar offering in effect https://www.otcmarkets.com/filing/html?id=17167586&guid=AxJ-k6p3ktlHJth
With all the massive $$ made last year, many are selling this week to avoid 2024 taxes. Now they have 16 months to pay! SMART. Opposite of a January effect
It's just a bad week.
LOL that's what I wanna know too :)
Maybe you can tell me what is making AIMD explode.
On December 28, 2023, Inspire Veterinary Partners, Inc. (“Inspire” or the “Company”) entered into an agreement (the “Agreement”) with Tumim Stone Capital LLC (the “Investor”), pursuant to which the Investor and the Company agreed to certain amendments to the previously disclosed common stock purchase agreement (the “Purchase Agreement”) and the registration rights agreement (the “Registration Rights Agreement”), each dated as of November 30, 2023, by and between the Company and the Investor.
Pursuant to the Agreement, the Company and the Investor agreed to amend the Purchase Agreement to provide that, if the number of commitment shares required to be issued by the Company to the Investor and its affiliates (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 promulgated thereunder) pursuant to the Purchase Agreement would result in the beneficial ownership by the Investor of more than 4.99% of the outstanding shares of Class A common stock of the Company, then the Company shall be obligated to deliver to the Investor: (i) the number of shares of Class A common stock that, after giving effect to the issuance thereof to the Investor, would result in the Investor and its affiliates beneficially owning one (1) share less than 4.99% of the outstanding shares of Class A common stock of the Company, and (ii) a warrant to purchase shares of Class A common stock (such warrant, the “Warrant” and the shares issuable upon exercise thereof, the “Warrant Shares”), granting the Investor the right to purchase, at an exercise price of $0.0001 per Warrant Share, up to that number of Warrant Shares equal to the difference between (x) the number of shares that would be required to be issued to the Investor as commitment shares but-for the 4.99% ownership limitation, and (y) the number of shares of Class A common stock to be issued to the Investor as commitment shares.
The Agreement further amends the Purchase Agreement to provide that, if the issuance of the total number of commitment shares of Class A common stock and Warrant Shares by the Company to the Investor would cause the beneficial ownership of the Investor and its affiliates to exceed 19.99% of the outstanding shares of Class A common stock of the Company, and the Company has not obtained stockholder approval for the issuance of such shares of Class A common stock in an amount in excess of the 19.99% ownership threshold in accordance with the applicable rules of The Nasdaq Capital Market on or before May 24, 2024, then the Company shall be obligated to pay to the Investor an amount in cash equal to $600,000 minus the value of the shares of Class A common stock issuable to the Investor as commitment shares and the value of the Warrant Shares issuable upon exercise of the Warrant.
Also pursuant to the Agreement, the Company and the Investor amended the Registration Rights Agreement to extend the filing deadline by which the Company must file an initial registration statement with the U.S. Securities and Exchange Commission (the “Commission”) with respect to the resale by the Investor of the shares of Class A common stock of the Company issuable to the Investor pursuant to the Purchase Agreement, including the commitment shares and the Warrant Shares, to January 31, 2024.
The summary descriptions in this Current Report on Form 8-K of the Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Agreement. The Company will file the Agreement with the Commission as an exhibit to its next Annual Report on Form 10-K.
NEWS
Safe and Green Development Corporation Announces Update on LOI for Acquisition of Xene Real Estate AI Software
https://ml.globenewswire.com/Resource/Download/17839f00-6850-4387-943e-d6c3144ad010/Safe and Green Development.png
XENE Platform
MIAMI, Fla, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Safe and Green Development Corporation (NASDAQ: SGD) (“SG Devco” or the “Company”) is pleased to announce an update to the previously announced proposed investment in Majestic World Holdings (“MWH”), a real estate technology firm and owner of the Xene AI Software platform (“XENE Platform”). After conducting initial due diligence, the Company has negotiated a complete acquisition of Xene Platform along with its parent company MWH. The company will look to complete the acquisition by the end of the first quarter subject to final approval by the Board of Directors and execution of definitive documents.
The XENE Platform, powered by advanced AI technology, has the goal of creating a decentralized real estate marketplace, creating an all-in-one solution that brings banks, institutions, home builders, clients, agents, vendors, gig workers, and insurers into a seamlessly integrated and structured AI-driven environment. This development is expected to significantly save time and resources for all parties involved. The XENE Platform streamlines property transactions, offering a cost-effective alternative to traditional buyers' agent models.
The XENE Platform completed a successful BETA launch earlier in 2023 and MWH has already started generating revenues. The XENE Platform is expected to launch to the public within the first quarter of 2024.
David Villarreal, President & CEO of Safe and Green Development Corporation, stated, “The successful BETA run earlier in 2023 has given us the confidence to move forward with a complete acquisition of the XENE Platform. This unique platform is expected to save banks and financial institutions time and money on foreclosure listings by leveraging the technology, property preservation, eviction, listing and sales, title, home warranty and homeowners’ insurance all in one place. We look forward to adding this line of business and diversifying our business portfolio.”
About Safe and Green Development Corporation
NEWS
Immunic Highlights 2023 Accomplishments and Upcoming Milestones
– Evidence for Neuroprotective Activity of Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis, Consistent Across the Entire Progressive Multiple Sclerosis Population and All Subtypes –
– Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing –
– Improvements in Gut Health Demonstrated in Phase 1b Clinical Trial of IMU-856 in Celiac Disease –
– Expanded Vidofludimus Calcium Patent Portfolio with Additional New Patents Granted; Exclusivity Protection Expected Into 2041 in the United States, Unless Extended Further –
– Significantly Strengthened Balance Sheet; Cash Runway Extended Into the Third Quarter of 2025 Based on First Tranch of January 2024 Financing –
NEW YORK, Jan. 5, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today highlighted its 2023 accomplishments and upcoming milestones.
"The past year has been an extra-ordinarily productive and successful one for Immunic, with key clinical data releases highlighting the uniqueness and enormous value potential of each of our two latest-stage clinical assets," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team. Regarding our lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium, the interim biomarker analysis from the phase 2 CALLIPER trial demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS). This effect was observed across all subpopulations, including non-active secondary progressive multiple sclerosis, which we believe represents the segment of greatest unmet need in multiple sclerosis (MS). We look forward to continuing development of this potentially groundbreaking asset. Enrollment in CALLIPER is complete, with top-line data expected in April 2025. Meanwhile, enrollment in our phase 3 ENSURE program remains active, with an interim futility analysis expected in late 2024 and the read-out of the first of the ENSURE trials anticipated in the second quarter of 2026."
Dr. Vitt continued, "Regarding IMU-856, our orally available and systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), results from our phase 1b trial demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. We believe this data provides initial clinical proof-of-concept for a potentially new therapeutic approach to a multitude of gastrointestinal disorders through the regeneration of bowel architecture rather than the traditional immunomodulatory approaches in many gastrointestinal indications. We are currently preparing for phase 2 testing in ongoing active celiac disease (OACD), with further clinical applications in other gastrointestinal disorders also being considered."
"On a scientific level, we announced preclinical evidence showing that vidofludimus calcium acts as a potent Nurr1 activator, which may be associated with both its hypothesized neuroprotective effects and the reduced disability-worsening events observed in our phase 2 EMPhASIS trial in relapsing-remitting MS patients. We have also continued to strengthen our patent portfolio for vidofludimus and its salt and free acid forms, with additional new layers of patents granted, now providing protection into 2041 in the United States and into 2038 internationally. We expect to continue to expand the patent protection around vidofludimus calcium in the future," Dr. Vitt continued.
"Financially, we announced a three-tranche private placement of up to $240 million earlier today. We expect the first $80 million tranche to extend our cash runway into the third quarter of 2025, which well covers the top-line data readout of our CALLIPER trial in Aprill 2025. The second tranche, assuming it is excersied, would even finance us into the first quarter of 2027. Despite challenging capital markets, we are proud to see enormous support from new and existing investors, including lead investor BVF Partners, as well as Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. Finally, I want to share my pride in our broader team, who were honored to win multiple, prestigious international awards in 2023 recognizing Immunic's excellence in a number of clinical, corporate and communications categories. I am very excited to see what our team can achieve in 2024 and beyond," concluded Dr. Vitt.
A more thorough review of recent events and upcoming milestones follows:
Corporate Highlights
Announced a three-tranche private placement of up to $240 million with participation from select new and existing investors today.
Strengthened Board of Directors in April 2023 with the addition of Richard Rudick, M.D., a thought-leader in MS with decades of experience in the clinic, academia and industry.
Vidofludimus Calcium 2023 Highlights and Upcoming Milestones
Reported positive interim data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS in October. Serum NfL improvements were consistently observed for vidofludimus calcium across PMS and all disease subtypes, as well as in patients who showed or did not show disease and/or magnetic resonance imaging (MRI) activity. Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential. Enrollment of the trial was completed in August. In total, 467 patients with primary PMS, or active or non-active secondary PMS, were randomized to either 45 mg of vidofludimus calcium or placebo.
Published preclinical data in the peer-reviewed, high impact, Journal of Medicinal Chemistry in May, confirming that vidofludimus calcium acts as a potent Nurr1 activator, in addition to its known mode of action as a dihydroorotate dehydrogenase (DHODH) inhibitor. Data showed that activation of Nurr1 could be responsible for the drug's postulated neuroprotective effects and may contribute to the previously reported reduction of confirmed disability worsening events seen in the phase 2 EMPhASIS trial in relapsing-remitting MS patients.
Reported positive data from the maintenance phase of the phase 2b CALDOSE-1 trial of vidofludimus calcium in patients with moderate-to-severe ulcerative colitis in April.
Significantly strengthened the multiple layers of patent protection around vidofludimus calcium, and other salt and free acid forms, with the receipt of two Notices of Allowance from the USPTO, covering the dosing regimens in MS and the dose strength for the treatment of RMS. The current patent portfolio provides protection into 2041 in the United States and into 2038 internationally, unless extended further.
Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025.
An interim futility analysis of the ENSURE program is expected in late 2024. The read-out of the first of the ENSURE trials is currently anticipated in the second quarter of 2026; and the second ENSURE trial in the second half of 2026.
IMU-856 2023 Highlights and Upcoming Milestones
Announced, for the first time, IMU-856's molecular mode of action as a highly selective and potent small molecule modulator of SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium, in May.
Announced positive results from the part C portion of the phase 1 clinical trial of IMU-856 in patients with celiac disease in May. The data demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. Immunic believes this data provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.
The company is preparing for clinical phase 2 testing of IMU-856 in OACD patients.
Award Recognition
MS R&D webcast held in November 2022:Gold German Stevie Awards for 'Best Medical Event' and 'Best B2B Event'American Business Gold Awards in the 'Conferences & Meetings – Medical Congress' and 'Conferences & Meetings – Scientific Congress' categories and Bronze Award in the 'Corporate & Community – B2B Event' categoryInternational Business Gold Award in the 'Conferences & Meetings - Medical Congress' category
Newly designed, accessibility-friendly website:Gold German Stevie Award for 'Best Overall Design' and Bronze Stevie Award for 'Special Achievement in Diversity & Inclusion'American Business Silver Award in the 'Achievement in Diversity & Inclusion' category
BioTech Breakthrough Award winner for the 'Developmental Immunology Solution of the Year' for the IMU-856 development program, including the positive phase 1b clinical trial results in celiac disease
Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, was awarded a Silver Stevie Award for Women in Business in the 'Women in Healthcare' category
Immunic's management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 42nd Annual J.P. Morgan Health Care Conference taking place January 8-11, 2024 in San Francisco. To schedule a meeting, please contact: Jessica Breu at jessica.breu@imux.com.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding expected future events, including the private placement and expected proceeds, strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's ability to raise additional capital, if needed; Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves
Do you have a link to the news? tia
Thank you, buddy! Hope you're doing well and happy new year!
Win or loose I had to take a shot. You know me well lol
Zorro just filled at $1.12 now gonna sleep on it lol
Nothing makes sense anymore! Most of the Pink Sheets have no liquidity anymore. This BS on the NASDAQ is the only game of chance lol
I'm jumping in now
I have to think a good chunk of that 7 million offering got bought. I'm thinking about taking a slice on a dip because IMHO this could fly past $2.00 tomorrow. Total game of craps but I'm a compulsive gambler :)
This baby is flying to new heights! Will be interesting how she does tomorrow
I used to trade this one. Haven't seen it in a while. There is an offering for 7.1 million shares
NEWS
Dermata Expands Global Intellectual Patent Portfolio with Issuance of Japanese Patent for DMT410 for the Treatment of Hyperhidrosis
- This is the Company's first patent issued for DMT410, using its Spongilla technology to topically deliver botulinum toxin for hyperhidrosis -
- The Company is currently discussing partnership opportunities to advance development of DMT410 -
- In 2022, the Japanese prevalence of hyperhidrosis was 10%, with approximately 6% having primary axillary hyperhidrosis -
SAN DIEGO, CA / ACCESSWIRE / January 4, 2024 / Dermata Therapeutics, Inc. (Nasdaq:DRMA, DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced the issuance of a new patent in Japan for its DMT410 program for the treatment of hyperhidrosis. The patent, entitled "Compositions for the treatment of skin conditions," (Japanese Patent No. 7395576) further strengthens Dermata's intellectual property for DMT410 for the treatment of hyperhidrosis and could lead to further protections for additional indications.
"We believe this patent issuance further validates DMT410's novel concept to easily deliver botulinum toxin topically instead of requiring patients to receive multiple injections," says Gerry Proehl, Dermata's Chairman, President, and CEO. "We are excited about the opportunities the DMT410 program can bring to patients, not only for the treatment of axillary hyperhidrosis as we have seen in our proof-of-concept study, but potentially for palmer and plantar hyperhidrosis which has no currently approved products. We also believe there are opportunities to use DMT410 to treat many aesthetic skin conditions like reducing pore number and size, decreasing sebum production, and reducing fine lines and wrinkles, all while improving the look and quality of facial skin," continued Mr. Proehl. "We also believe this new patent could aid us in our partnership discussions with a company that has a botulinum toxin to further develop the DMT410 program for multiple indications."
About DMT410
So tell me who's baby is this?
NEWS
CCC Intelligent Solutions Announces Pricing of Upsized Secondary Offering of 22 Million Shares of Common Stock
CHICAGO--(BUSINESS WIRE)-- CCC Intelligent Solutions Holdings Inc. (the “Company”) (NASDAQ: CCCS) today announced the pricing of the previously announced secondary offering of shares of the Company’s common stock (the “Offering”) by affiliates of Advent International, L.P. (the “Selling Stockholders”). The Offering consists of 22 million shares of the Company’s common stock, upsized from the previously announced 20 million shares. The shares will be offered from time to time for sale through negotiated transactions or otherwise at market prices prevailing at the time of sale. The Offering is expected to close on or about January 8, 2024, subject to the satisfaction of customary closing conditions. The Offering consists entirely of shares of the Company’s common stock to be sold by the Selling Stockholders, and the Company will not receive any proceeds from the sale of the shares being offered by the Selling Stockholders.
J.P. Morgan, Barclays and Citigroup are acting as joint book running managers for the Offering. The Offering is being made pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333-267793), which has been filed with the Securities and Exchange Commission (“SEC”) and became effective on October 14, 2022. The Offering is being made only by means of a prospectus supplement and the accompanying base prospectus. You may get these documents for free, including the prospectus supplement, once available, by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the prospectus supplement, once available, and the accompanying base prospectus may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, by mail at 1155 Long Island Avenue, Edgewood, New York 11717, by telephone: (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com, Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at barclaysprospectus@broadridge.com or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (800) 831-9146.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Arena Group Shares Surge 42% on Report of Takeover Offer
Published: Jan. 3, 2024 at 5:57 p.m. ET
C4 Therapeutics (CCCC) Gains 310% in 3 Months: Here's Why = https://finance.yahoo.com/news/c4-therapeutics-cccc-gains-310-161000432.html
Omega Therapeutics Stock Surges 99% Following Pact with Novo Nordisk to Treat obesity
Published: Jan. 4, 2024 at 7:06 a.m. ET
Novo Nordisk enters into research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases
January 04, 2024 05:59 ET
| Source: Novo Nordisk A/S
Share
Omega collaboration will leverage the company’s platform to develop an epigenomic controller as part of a new approach to obesity management
Cellarity collaboration will build upon initial work and engage the company’s platform to develop a small molecule therapy in metabolic dysfunction-associated steatohepatitis (MASH)
First two research programmes signed under existing partnership between Novo Nordisk and Flagship Pioneering
Novo Nordisk will reimburse R&D costs and each company and Flagship’s Pioneering Medicines are eligible to receive up to 532 million US dollars in upfront and milestone payments, as well as tiered royalties
Bagsværd, Denmark, Cambridge, Mass., and Somerville, Mass. 4 January, 2024 – Novo Nordisk, Omega Therapeutics, Inc.
https://www.globenewswire.com/news-release/2024/01/04/2803788/0/en/Novo-Nordisk-enters-into-research-collaborations-with-Omega-Therapeutics-and-Cellarity-on-novel-treatment-approaches-for-cardiometabolic-diseases.html
Omega Therapeutics Stock Surges 99% Following Pact with Novo Nordisk to Treat obesity
Published: Jan. 4, 2024 at 7:06 a.m. ET
Novo Nordisk enters into research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases
January 04, 2024 05:59 ET
| Source: Novo Nordisk A/S
Share
Omega collaboration will leverage the company’s platform to develop an epigenomic controller as part of a new approach to obesity management
Cellarity collaboration will build upon initial work and engage the company’s platform to develop a small molecule therapy in metabolic dysfunction-associated steatohepatitis (MASH)
First two research programmes signed under existing partnership between Novo Nordisk and Flagship Pioneering
Novo Nordisk will reimburse R&D costs and each company and Flagship’s Pioneering Medicines are eligible to receive up to 532 million US dollars in upfront and milestone payments, as well as tiered royalties
Bagsværd, Denmark, Cambridge, Mass., and Somerville, Mass. 4 January, 2024 – Novo Nordisk, Omega Therapeutics, Inc.
https://www.globenewswire.com/news-release/2024/01/04/2803788/0/en/Novo-Nordisk-enters-into-research-collaborations-with-Omega-Therapeutics-and-Cellarity-on-novel-treatment-approaches-for-cardiometabolic-diseases.html
Won't Get Fooled Again
Won't Get Fooled Again
You should give these clowns a call and ask them why. https://abvcpharma.com/
The company is dumping new shares into buyers.
Yeah! Nice! :)
NEWS
Sigma Additive Solutions Completes Acquisition of Travel Technology Company NextTrip Holdings
Sigma Additive Solutions Shareholders Approved Proposals Enabling Acquisition of NextTrip Holdings, Inc. on December 28, 2023
NextTrip Specializes in Using Proprietary Technology, Analytics and Strategic Partnerships to Provide Specialized Solutions in Leisure, Wellness and Business Travel
SANTA FE, NM / ACCESSWIRE / January 3, 2024 / Sigma Additive Solutions, Inc. (NASDAQ:SASI) ("Sigma", "we," "our," or the "Company") today announced the completion of its acquisition of NextTrip Holdings, Inc., a travel technology company based in Sunrise, Florida ("NextTrip"), through a previously announced share exchange. The acquisition, which was first announced October 2023, closed on December 29, 2023, at which time NextTrip became a wholly owned subsidiary of the Company. Additionally, effective upon closing of the acquisition, Jacob Brunsberg, President and Chief Executive Officer of Sigma, resigned from such roles, and Bill Kerby, Chief Executive Officer of NextTrip, was appointed a Chief Executive Officer of Sigma. Mr. Brunsberg will continue to serve as a director on Sigma's board.
On December 28, 2023, at Sigma's 2023 annual meeting of shareholders, Sigma shareholders voted to approve the issuance of shares of Sigma common stock associated with the acquisition of NextTrip, pursuant to the Share Exchange Agreement entered into with NextTrip and certain other parties in October 2023, and to further approve the terms of such Share Exchange Agreement.
"We are pleased to have received the overwhelming support of shareholders that voted for this transformative acquisition," said Jacob Brunsberg, former President and Chief Executive Officer of Sigma. "We look forward to integrating NextTrip in the near-term and working with the NextTrip team to increase shareholder value by providing a significant opportunity to participate in a leading travel brand with an array of product offerings and concierge services."
Bill Kerby, Chief Executive Officer of NextTrip and the newly appointed Chief Executive Officer of Sigma, commented, "We thank everyone who participated in the meeting and vote, and believe the acquisition will maximize value for all shareholders. This transaction will allow NextTrip the ability to execute our strategic growth plans and expand our reach into new markets as part of a public company for the benefit of Sigma equity holders, while tying the issuance of additional earn out equity to clear business objectives for NextTrip. Our growth and expansion plans are highly focused on the roll out of key technology developments that will broaden our footprint as an innovative travel technology company specializing in using proprietary technology, analytics, and strategic partnerships to provide customized, unique and differentiated travel solutions in leisure, wellness, and business travel. As a public company with access to additional sources of capital, we will be focused on scaling our travel booking engine that, prior to the COVID-19 pandemic, had an over 6 million legacy customer database and generated over $400 million in bookings in 2019."
Lyndsey North, President of NextTrip, commented, "This transaction is the capstone to a foundation-building 2023 for NextTrip, and we believe that it positions us for a transformational year ahead. Throughout the year we continued to position NextTrip as a significant player in the travel space, building over 200 direct relationships with blue-chip travel organizations, as well as major industry suppliers for air, hotel and other travel and travel-related services to ensure robust products and an offering of more than 2 million hotels worldwide. Our focus was on contracting and re-contracting with travel product suppliers and connecting APIs with vendors and suppliers. Our platform is now directly connected to top channel managers such as Dingus, HBSI and more. We also have in place a dedicated U.S.-based call center team with decades of product and destination knowledge.
"Our team has been diligently working on a comprehensive technology update and integration of our acquired scalable travel booking engine into the NextTrip ecosystem in preparation for its full launch. A soft launch in late November 2023 resulted in top-line revenue growth of over 75% vs the prior month. At go-live, we expect to have over 3 million properties available in more than 200 countries worldwide. Additionally, we have a curated collection of more than 200 of the most sought-after resorts in Mexico and the Caribbean that we intend to strategically scale. In the past several weeks, we have been beta testing the platform, technology, and connections. A marketing beta program received strong opens and conversions to bookings. We are now preparing to shift to the live production site and ramping up marketing to our 6+ million customer database, with a target launch in the next 30-60 days. Looking ahead into 2024, we are highly enthusiastic for our business and expect the launch and ramp of our booking platform will act as a significant accelerator for NextTrip," concluded North.
Additional information about the acquisition and the terms thereof are included in the Current Reports on Form 8-K filed by Sigma with the Securities and Exchange Commission (SEC) on October 10, 2023 and January 3, 2024, as well as the Definitive Proxy Statement filed by Sigma with the SEC on December 1, 2023. Additional information about Sigma's annual meeting of shareholders and items approved at thereat are included in the Current Report on Form 8-K filed by Sigma with the SEC on January 2, 2023, as well as the Definitive Proxy Statement filed by Sigma with the SEC on December 1, 2023.
Highlights of NextTrip & the Acquisition
As previously announced on October 13, 2023, Sigma entered into a Share Exchange Agreement with NextTrip and certain other parties, pursuant to which it agreed to acquire 100% of the capital stock of NextTrip in exchange for shares of Sigma common stock constituting 19.99% of its outstanding common stock at closing of the acquisition, plus additional contingent shares of Sigma common stock upon the achievement of post-closing milestone earnouts tied to the business performance of NextTrip.
Assuming all business milestones are achieved, NextTrip's equity holders will receive a total of 6 million shares of Sigma common stock, resulting in existing Sigma holders retaining, on a pro forma basis, approximately 11.5% of the total outstanding shares.
At closing, Sigma President and CEO, Jacob Brunsberg, resigned from such roles (but will remain a director on the company's board), and NextTrip CEO, William Kerby was appointed as CEO of the company. Additionally, Mark Ruport, chairman of the company's board of directors, resigned, and Donald Monaco, who was designated by NextTrip, was appointed as a director and chairman to fill the vacancy created by Mr. Ruport's resignation.
Going forward, the remaining board seats will continue to be filled by Sigma's current directors during the realignment period, with NextTrip earning the right to designate additional board members and officers upon reaching business milestones in accordance with the Share Exchange Agreement.
The company intends to change its ticker symbol to "NTRP" in the near future, and subject to stockholder approval, to change the name of the company to NextTrip, Inc.
Lake Street Capital Markets acted as the financial advisor to Sigma in connection with the acquisition.
The acquisition provides the opportunity for NextTrip to become a publicly traded company on Nasdaq. The transaction will be transformational since, as a public company, NextTrip is expected to have access to additional sources of capital on more favorable terms to fund strategic growth initiatives, as well as the ability to tap into adjacent markets and more efficiently scale existing operations.
NextTrip recently completed the acquisition and integration of a scalable travel booking engine that, prior to the COVID-19 pandemic, had a 6 million + legacy customer database and generated over $400 million in bookings in 2019. The parties expect that the booking engine acquisition will act as a significant accelerator to the company's business.
NextTrip has assembled a team with more than 100 years of combined travel experience that brings deep experience across key areas of the travel industry including online travel distribution, wholesale distribution and travel technology. We believe that the team's strong relationships and industry experience serve as a catalyst for positioning NextTrip as a significant player in the travel space.
In 2023, NextTrip established more than 200 direct relationships with blue-chip travel organizations, as well as major industry suppliers for air, hotel and other travel and travel-related services to ensure robust products and an offering of more than 2 million hotels worldwide.
Following a period of strategic realignment which is tied to certain NextTrip business objectives, NextTrip's potential future initiatives will be focused on driving the company's renewed growth agenda, exploring strategic M&A to drive revenue synergies through the expansion of product and travel consumer offerings, and continuing to invest in the development of innovative technologies to connect travel customers for discovery and booking domestic and international destinations.
About NextTrip
NextTrip is a technology-driven platform delivering innovative solutions for business and leisure travel. NextTrip Leisure provides individual and group travelers with vacations to the most popular and sought-after destinations in Mexico, the Caribbean and across the world. NextTrip Business is an online corporate travel and expense management solution with a large inventory of travel options and discounted rates. NextTrip Solutions offers travel technologies that make the jobs of alternative lodging property managers, wholesalers, distributors and other travel industry players easier and more efficient. For more information and to book a trip, visit https://investors.nexttrip.com/.
About Sigma Additive Solutions
Sigma Additive Solutions, Inc. has historically been a provider of in-process quality assurance (IPQA™) solutions to the additive manufacturing industry. Sigma has specialized in the development and commercialization of real-time monitoring and analytics known as PrintRite3D® for 3D metal and polymer advanced manufacturing technologies. PrintRite3D detects and classifies defects and anomalies real-time during the manufacturing process, enabling significant cost-savings and production efficiencies by reducing waste, increasing yield, and shortening cycle times.
As previously disclosed in Sigma's filings with the SEC, in October 2023 Sigma entered into an Asset Purchase Agreement, pursuant to which it has agreed to sell its historic business to Divergent Technologies, Inc. The sale is expected to be completed in January 2023, at which time the NextTrip business will become the sole business of the company.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of
All a game of Craps my friend.
Excellent! Once the market opens this could blow its top!
As of November 9, 2023, there were 7,231,940 shares of common stock, par value per share $0.001, issued and outstanding.
ABVC BioPharma and its Subsidiary Receive $460M From AiBtl BioPharma as the First Milestone Payment of Global Licensing Fees
FREMONT, CA , Jan. 03, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) and its subsidiary BioLite, Inc. ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and oncology/hematology, announced today that the Company and its subsidiary received an aggregate of 46 million shares from AiBtl BioPharma Inc. ("AiBtl"), as its first milestone payment under a global licensing agreement. The agreement between the Company and AiBtl placed a value of $460 ($10 per share) on such payment. AiBtl is a private company, and the share value is based on the terms of the agreement between the parties and the valuation report done by an independent third party.
The Company entered into a definitive global licensing agreement with AiBtl on November 12, 2023, for the Company's CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder). According to the terms of the agreement, AiBtl delivered 46M shares to the Company as the first milestone payment. The Company expects AiBtl to achieve the further milestones under the agreement, upon which the Company may receive the remaining licensing fees of up to $7M cash and 5% royalties of net sales, up to $200M.
"I am pleased with the progress of ABVC and AiBtl's collaborative work, which reflects ABVC's strength to grow and increase cash flow," said Uttam Patil, Ph.D., Chief Executive Officer of ABVC. He continued, "After this licensing payment, AiBtl becomes a subsidiary of ABVC, which holds 57% of the consolidated shares of AiBtl; accordingly, AiBtl is now also considered a related party.
“We believe this milestone payment marks the beginning of ABVC's revenue generation through licensing deals and opens new avenues that could potentially increase ABVC's revenue. AiBtl will help ABVC conduct international business development for the MDD and ADHD markets and bridge the partnership with international pharmaceutical companies."
"Completing out-licensing for the licensed products is our priority to strengthen our collaboration with ABVC," said AiBtl's Chief Executive Officer Russman Jaimes. He further commented, "AiBtl is a US company registered in Delaware. We are working on progressive joint ventures in Asia to expand the healthcare business and are poised to strengthen it. With ABVC's strong pipeline of products, we believe AiBtl has a strong future."
Management believes the Company's pipeline of products has excellent market potential. As per the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032 with a CAGR of 2.8% over the forecast period[1]. According to the Polaris market research report, the global ADHD treatment market was valued at $15.23 billion in 2022 and is expected to grow at a CAGR of 7.3% over the forecast period between 2023-2032.[2] Straits Research reports that the global botanical drug market size was valued at $163 million in 2021 and is expected to be valued at $3.2 billion; the market is expected to grow at a CAGR of 39% during the forecast period (2022–2030).[3]
About ABVC BioPharma & Its Industry
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company's network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials for PMA (pre-Market Approval).
Forward-Looking Statements
This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential," or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company's securities in any state or jurisdiction in which such offer, solicitation or sale wo