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NEWS -- FuelPositive Approaches Activation as Strategic Alliances Strengthen
WINNIPEG, MB, Aug. 26, 2024 /CNW/ - FuelPositive Corporation (TSXV: NHHH) (OTCQB: NHHHF) (the "Company") is pleased to provide a comprehensive update highlighting significant progress as the Company closes in on system activation and broadens its network of strategic partners.
Key Highlights:
NEWS -- Scorpius Holdings CEO Provides Corporate Update; Highlights Expanding Sales Pipeline, Enhanced Manufacturing Capabilities, and Path Toward Positive Cash Flow
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today released a letter to shareholders from its CEO Jeff Wolf:
"We are excited to share an update on Scorpius as we continue to position the company to take a lead role in catering to the rapidly growing biologic and cell therapy markets. Over the past several years, we have made significant investments designed to establish Scorpius as a leading biologic manufacturing CDMO. Notably, we have expanded our mammalian and microbial production capability to enable us to offer a broad range of biologic manufacturing services to our customers. Our robust investments and ongoing efforts have already resulted in a threefold increase in revenue for the first half of 2024. Our current sales pipeline now includes more than $100 million in weighted opportunities across the biopharmaceutical and government sectors.
Given the extensive opportunities before us, we recently completed a financing, raising approximately $14.4 million in gross proceeds. These funds will enable us to better service our existing clients as well as attract larger prospective customers as we diversify our customer base with a strong mix of commercial and government opportunities. Additionally, we have started transitioning several key clients from the process development phase into full-scale manufacturing, enabling an additional revenue stream and marking a significant shift in our operational focus.
We believe that Scorpius is now exceptionally well-positioned to service new and existing clients, expand its service offering and achieve positive cash flow in the near future. Given these overarching goals, we are taking steps to align senior executive compensation with our growth objectives, contingent on meeting sales targets and booking goals.
We’ve built and staffed a state-of-the-art CDMO with a scalable and high-margin business model. Scorpius’ profile and reputation for quality biomanufacturing is indeed growing in the industry. With the closing of this financing, we are now well positioned to deliver significant returns to our shareholders in the years to come."
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as continuing to position the Company to take a lead role in catering to the rapidly growing biologic and cell therapy markets, the current sales pipeline now including more than $100 million in weighted opportunities across the biopharmaceutical and government sectors, the funds raised enabling the Company to better service its existing clients as well as attract larger prospective customers the Company being well-positioned to service new and existing clients, expand its service offering and achieve positive cash flow in the near future and being well positioned to deliver significant returns to the Company’s shareholders in the years to come. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to expand its large molecule biomanufacturing CDMO services, attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Scorpius Holdings Achieves 16% Year-Over-Year Increase in Revenue for the Second Quarter of 2024
Reduces operating expenses by 25%
Pipeline surpasses $100 million in weighted opportunities across the government and manufacturing sectors
DURHAM, N.C., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today provided strategic, financial, and operational updates for the second quarter ended June 30, 2024.
Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, “We are extremely proud of the progress Scorpius achieved in the second quarter of 2024. Despite facing a quarter with significant working capital challenges, our revenues still increased by 16% and we reduced our operating expenses by 25% over the same period last year. With our recently completed financing, we now have a much stronger balance sheet to capitalize on a number of exciting projects in front of us. We anticipate this funding will not only allow us to accelerate our revenue growth but should enable us to achieve our goal of positive cash flow.”
“Our success this year highlights the significant progress we’ve made in both innovation and customer-focused program management across our service platforms. This progress is most clearly reflected in the strength of our pipeline, which now surpasses $100 million in weighted opportunities across the government and manufacturing sectors. We anticipate closing many of these opportunities by year’s end. As we look ahead, we are confident in our ability to sustain this momentum as we continue to execute our strategic initiatives and deliver value to our shareholders.”
Second Quarter 2024 Financial Results
For the three months ended June 30, 2024, the Company recognized $0.8 million of revenue, primarily from process development, compared to $0.7 million of process development revenue recognized in the 2023 comparable quarter. The increase in process development revenue is attributable to the completion of services over a larger number of customer contracts.
Cost of revenues were $0.8 million and $0.4 million for the three months ended June 30, 2024, and 2023, respectively, and primarily consisted of the direct cost of labor, overhead and material costs at Scorpius. The increase in cost of revenues is due to the expanded service offerings and completed milestone work on multiple CDMO contracts.
Research and development expenses were $3.6 million for the three months ended June 30, 2024, compared to $5.2 million for the three months ended June 30, 2023.
Selling, general and administrative expenses were $5.0 million and $7.0 million for the three months ended June 30, 2024, and 2023, respectively. The decrease of $2.0 million was primarily due to decreases in consultant services of $1.1 million, professional services of $0.4 million, sales and marketing of $0.2 million, and stock-based compensation of $0.3 million.
For the three months ended June 30, 2024, there was no change in fair value of contingent earn-out receivable, related party.
Total non-operating expense was ($0.6) million for the three months ended June 30, 2024, which primarily consisted of $0.6 million from the loss on disposal of leasehold improvements, $0.2 million of interest expense on finance leases, partially offset by $0.2 million from gain on partial extinguishment of debt. Total non-operating expense was ($0.2) million for the three months ended June 30, 2023, which primarily consisted of ($0.2) million of interest expense, ($0.1) million of loss on disposal of equipment, partially offset by ($0.1) million of interest income.
Net loss attributable to Scorpius was approximately $8.9 million, or ($26.98) per basic and diluted share, for the three months ended June 30, 2024, compared to approximately $13.9 million, or ($106.67) per basic and diluted share, for the three months ended June 30, 2023.
As of June 30, 2024, the Company had approximately $1.5 million in cash and cash equivalents and short-term investments. As of August 19, 2024, the Company’s cash and cash equivalents and short-term investments were approximately $13.2 million.
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as being able to capitalize on a number of exciting projects in front of the Company, the funding allowing the Company to accelerate its revenue growth and enable it to achieve its goal of positive cash flow, the Company’s pipeline, surpassing $100 million in weighted opportunities across the government and manufacturing sectors, the closing of many of the pipeline opportunities by year’s end, and the Company’s ability to sustain the momentum as it continues to execute its strategic initiatives and deliver value to its shareholders. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to expand its large molecule biomanufacturing CDMO services, attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Scorpius Holdings, Inc. Announces Closing of Public Offering
Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the closing of its underwritten public offering of 14,375,000 shares of common stock (and/or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof), including full exercise of the underwriter’s over-allotment option. Each share of common stock (or Pre-Funded Warrant) was offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $14,375,000, before deducting underwriting discounts and offering expenses.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity acted as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887) relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions and include statements regarding the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
NEWS -- Theriva Biologics Announces Reverse Stock Split
ROCKVILLE, Md., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, announced today a reverse stock split of its issued and outstanding common stock, par value $0.001 per share, at a ratio of one (1) share of common stock for every twenty five (25) shares of common stock, effective as of 12:01 a.m. (Eastern Time) on August 26, 2024 (the “Effective Date”). The Company’s common stock will begin trading on a split-adjusted basis when the market opens on August 26, 2024. The reverse stock split was authorized by the Company’s Board of Directors on August 15, 2024. Pursuant to the laws of the State of Nevada, the Company’s state of incorporation, the Company’s Board of Directors has the authority to effect a reverse stock split without shareholder approval if the number of authorized shares of common stock and the number of outstanding shares of common stock are proportionally reduced. The Company will file a certificate of change to its articles of incorporation, as amended, with the Secretary of State of Nevada to effect the reverse stock split. The Company’s common stock will continue to trade on the NYSE American under the stock ticker “TOVX” but will trade under the new CUSIP number 87164U 508.
As a result of the reverse split, each twenty five (25) pre-split shares of common stock outstanding will automatically combine into one (1) new share of common stock without any action on the part of the holders, and the number of outstanding common shares will be reduced from 25,131,230 shares to 1,005,249 shares without taking into account fractional shares.
The reverse stock split is being effected to ensure that the Company can meet the per share price requirements of the NYSE American, the Company's current listing exchange.
No fractional shares will be issued as a result of the reverse stock split. Shareholders who otherwise would be entitled to a fractional share because they hold a number of shares not evenly divisible by the 1 (one) for twenty five (25) reverse split ratio, will automatically be entitled to receive an additional fractional share of the Company’s common stock to round up to the next whole share.
The Company’s transfer agent, Equiniti Trust Company, which is also acting as the exchange agent for the reverse split, will send instructions to stockholders of record who hold stock certificates regarding the exchange of their old certificates for new certificates, should they wish to do so. Stockholders who hold their shares in brokerage accounts or “street name” are not required to take action to effect the exchange of their shares.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at https://www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding our planned stock split. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the stock split having the desired effect, the ability to continue to enroll patients as planned, generating clinical data that establishes VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers; the Company’s and VCN’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s and VCN’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s and VCN’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s and VCN’s ability to maintain license agreements, the continued maintenance and growth of the Company’s and VCN’s patent estate, the ability to continue to remain well financed and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
NEWS -- Realbotix Corp. to Release its Financial Results for Q3-2024 on August 28, 2024
TORONTO--(BUSINESS WIRE)--Realbotix Corp. (TSX-V: XBOT | Frankfurt Stock Exchange: 76M | OTC: XBOTF) (“Realbotix” or the “Company”), a leading creator of humanoid robotics and relationship-based AI, is pleased to share that it will release its financial results for the three and nine months ended June 30, 2024 (“Q3-2024”) on August 28, 2024.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q3 2024 financial results starting at 1:00 pm ET on August 28, 2024.
Date: August 28, 2024
Time: 1:00 p.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_TjbW3o4WTr6xRrLkISqc-Q
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Realbotix
Transcending the barrier between man and machine, Realbotix creates customizable, full-bodied, human-like robots with AI integration that improve the human experience through learning, connection and play. Manufactured in Nevada, USA, Realbotix has built a reputation for having the highest quality humanoid robots and the most realistic silicone skin technology on the market. Our target addressable markets are massive, most of them in the tens or hundreds of billions USD.
Our mission is to create robots and AI that are indistinguishable from humans in appearance and social interaction. Realbotix replicates the physical and emotional aspects of being human, in hardware and software. This versatility makes our robots and their personalities customizable and programmable to suit a wide variety of use cases.
Visit https://Realbotix.AI to learn more.
Keep up-to-date on Realbotix.AI developments and join our online communities on Twitter, LinkedIn, and YouTube.
Follow Aria, our digital avatar on Instagram and TikTok.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as “may”, “will”, “plan”, “expect”, “anticipate”, “estimate”, “intend” and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedarplus.ca. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contacts
Realbotix Corp.
Andrew Kiguel, CEO
Email: mailto://contact@realbotix.ai
Jennifer Karkula, Head of Communications
Email: mailto://contact@realbotix.ai
Telephone: 647-578-7490
Again with the $1 a share. Wouldn't they have gobbled it up at $2 or even $3 a share?
NEWS -- Scorpius Holdings, Inc. Announces Pricing of Public Offering
DURHAM, N.C., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the new pricing of an underwritten public offering of 12,500,000 shares of common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The gross proceeds to the Company from the offering are expected to be approximately $12,500,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,875,000 shares of common stock and/or Pre-Funded Warrants solely to cover over-allotments, if any. As previously announced, the Company had terminated the pricing of its underwritten public offering that it had announced on August 6, 2024. Subsequently, the Company requested, and the NYSE American approved, a financial viability exception to the NYSE American stockholder approval rules that would allow the Company to proceed with the closing of the underwritten public offering upon the terms set forth above.
The offering is expected to close on August 19, 2024, subject to satisfaction of customary closing conditions and trading of the Company’s common stock on the NYSE American is expected to resume that same day.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions and include statements regarding the timing and completion of the proposed offering, the timing that trading will resume and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
NEWS -- Lineage Cell Therapeutics to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference
CARLSBAD, Calif., August 13, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will be presenting at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference being held on Thursday, August 15, 2024. Lineage’s presentation will be available for viewing on-demand, beginning on Thursday, August 15, 2024, at 7:00am ET, for registered conference attendees.
Interested parties can also register to view a replay of the presentation on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf" cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240813574683/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Plus Therapeutics Presents Positive Clinical Trial Results at the 2024 SNO/ASCO CNS Metastases Conference
Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, presented data from the FORESEE study of its CNSide platform for the diagnosis and management of LM. The data were presented in a podium presentation at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.
The study, titled “A Therapy Treatment Response Trial in Patients with Leptomeningeal Metastases (LM) Using CNSide (FORESEE Study, NCT05414123),” was a prospective, multi-center observational trial enrolling 39 patients with Breast (21 patients) or Non-Small Cell Lung Cancer (18 patients) with a suspected or confirmed diagnosis of LM. The primary endpoint of the study assessed how CNSide test results influenced clinical decision-making. Secondary endpoints assessed CNSide vs. the gold standard of LM diagnosis, CSF cytology, and its use for personalization of treatment selection based on tumor molecular phenotype. The study was presented by Priya U. Kumthekar, M.D., Associate Professor of Neurology and Medicine at Northwestern University and FORSEE Trial Principal Investigator.
Key results from the FORESEE trial:
Due to a trading halt, as of Friday, August 9, 2024, and until further notice, Scorpius Holdings, Inc., (CUSIP 42237K508) is no longer eligible for stock loan or collateral pledge at OCC (The Foundation for Secure Markets). Only share reducing transactions will be allowed on outstanding stock loan and borrow positions. Any equity pledges for collateral purposes will receive no value. If you have any questions regarding this memo, please contact your firm’s designated credit risk representative.
NEWS -- Plus Therapeutics Presents Positive Interim ReSPECT-LM Phase 1 Data for Leptomeningeal Metastases at 2024 SNO/ASCO CNS Metastases Conference
Respect-LM dosing shows continued feasibility and safety of up to 44 mCi of intrathecal Rhenium (186Re) Obisbemeda
High absorbed radiation doses, mean circulating tumor cell reductions, and median overall survival of 12 months continue to show clinical promise
AUSTIN, Texas, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, presented data in a podium presentation updating the progress of its ReSPECT-LM clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM). The data were presented at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.
The presentation, titled, “Phase 1 Dose Escalation of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Ongoing Clinical Study Update for Initial Safety and Feasibility,” provided a safety and efficacy update on the single dose trial for the first 4 cohorts (n = 16 patients). The trial is currently enrolling in Cohort 5. The study was presented by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.
Key ReSPECT-LM highlights through Cohort 4:
NEWS -- Scorpius Holdings, Inc. Provides Update on its Previously Announced Public Offering
August 09 2024 - 3:38PM
Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced a delay in its previously announced public offering. The Company has requested, and the NYSE has approved, a financial viability exception to the NYSE American shareholder approval rules that would allow it to proceed with the closing of an underwritten public offering. The Company intends to pursue the sale of 12,500,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof, exclusive of the over-allotment option) at a price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The underwriting agreement was terminated in connection with the previously announced offering and a new underwriting agreement will be entered into if the offering is consummated. There can be no assurance that the Company will be able to consummate an offering under these terms or otherwise. The Company will adhere to all applicable provisions relating to the exemption, as outlined in Section 710 of the NYSE American Company Guide, and a closing is intended to occur ten days following the mailing of a notification letter to the Company’s shareholders.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions and include statements regarding the repricing of the offering, the ability to consummate an offering under the specified terms or otherwise the timing and completion of the proposed offering and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
Class action is on the way.
NEWS -- Lineage Cell Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
NEWS -- Plus Therapeutics to Announce Second Quarter Financial Results and Host Conference Call on August 14, 2024
AUSTIN, Texas, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report second quarter 2024 financial results on Wednesday, August 14, 2024, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Webcast and Conference Call
Date/Time: Wednesday, August 14, 2024 @ 5:00 PM ET
Webcast: https://edge.media-server.com/mmc/p/mtnrwhh5
Dial-in Link: https://register.vevent.com/register/BI1c575c6aa37840b9872f3ad10091195c
Participants are encouraged to pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
NEWS -- Scorpius Holdings, Inc. Announces Pricing of Public Offering
DURHAM, NC / ACCESSWIRE / August 6, 2024 / Scorpius Holdings, Inc. (NYSE American:SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), today announced the pricing of an underwritten public offering of 12,500,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The gross proceeds to the Company from the offering are expected to be approximately $12,500,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,875,000 shares of common stock and/or Pre-Funded Warrants solely to cover over-allotments, if any. The offering is expected to close on August 8, 2024, subject to satisfaction of customary closing conditions.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions and include statements regarding the timing and completion of the proposed offering and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company's annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
SOURCE: Scorpius BioManufacturing
NEWS -- Scorpius Holdings Weighted-Average Pipeline Surpasses $100 Million in Business Develop Opportunities Across Both Manufacturing Client and Government Sectors
Anticipates substantial booked business and associated revenues in Q3/Q4
DURHAM, NC / ACCESSWIRE / August 6, 2024 / Scorpius Holdings, Inc (NYSE American:SCPX), ("Scorpius" or the "Company"), an integrated contract development and manufacturing organization (CDMO), today announced that it has surpassed $100 million in weighted average pipeline of its near-term business development opportunities across both government and manufacturing client sectors. The weighted average pipeline is represented by written proposals which are subject to the execution of definitive agreements. The Company expects these opportunities to translate into substantial booked business and associated revenues over the next two quarters; however there can be no assurance of this.
Key opportunities include:
NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at Canaccord Genuity's 44th Annual Growth Conference
SAN DIEGO and CALGARY, AB, Aug. 2, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Chief Medical Officer Dr. Thomas Heineman will participate in a fireside chat at Canaccord Genuity's 44th Annual Growth Conference, which is taking place August 13-15, 2024 at the InterContinental Boston Hotel in Boston, MA. Additional details on the fireside chat can be found below.
Date: Tuesday, August 13, 2024
Time: 8:30 a.m. ET
Location: InterContinental Boston, Hutchinson Room
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Canaccord representative, or email mailto://jpatton@oncolytics.ca.
A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-canaccord-genuitys-44th-annual-growth-conference-302213197.html
SOURCE Oncolytics Biotech® Inc.
NEWS --Oncolytics Biotech® Reports Second Quarter 2024 Financial Results and Operational Highlights
https://www.newswire.ca/news-releases/oncolytics-biotech-r-reports-second-quarter-2024-financial-results-and-operational-highlights-830755680.html
NEWS -- Lineage Cell Therapeutics to Report Second Quarter 2024 Financial Results and Provide Business Update on August 8, 2024
CARLSBAD, Calif., August 01, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its second quarter 2024 financial and operating results on Thursday, August 8, 2024, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 8, 2024, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2024 financial and operating results and to provide a business update.
Interested parties may access the conference call on August 8th, 2024, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 15th, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6024260.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240801608382/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Theriva™ Biologics Receives Rare Pediatric Drug Designation by the U.S. FDA for VCN-01 for the Treatment of Retinoblastoma
ROCKVILLE, Md., July 31, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma. VCN-01, Theriva’s lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.
“The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. Most recently, results from the investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Data from this study will further inform our clinical development pathway in this area of high unmet need.”
The FDA grants RPDD for rare diseases (fewer than 200,000 affected persons in the United States) that are serious and life-threatening and primarily affect children ages 18 years or younger. If a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA, Theriva may be eligible to receive a Priority Review Voucher that can be redeemed to receive a priority review for any subsequent marketing application or may be sold or transferred.
About Retinoblastoma
Retinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 - 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population < 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In the U.S., retinoblastoma shows an incidence rate of 3.3 per 1,000,000 with only about 200 to 300 children diagnosed per year according to the American Cancer Society. Preserving life and preventing the loss of an eye, blindness and other serious effects of treatment that reduce the patient’s life span or the quality of life, remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.
About VCN-01
VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at https://Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at https://www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding continuing to work closely with leading physicians and regulatory agencies to refine the Company’s clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma, the data from the investigator sponsored Phase 1 trial at Hospital Sant Joan de Déu in Barcelona evaluating intravitreal VCN-01 in pediatric patients with refractory retinoblastoma informing the Company’s clinical development pathway and being eligible to receive a Priority Review Voucher. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s and VCN’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned and receive a Priority Review Voucher, the Company’s and VCN’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits,; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s and VCN’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s and VCN’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s and VCN’s ability to maintain license agreements, the continued maintenance and growth of the Company’s and VCN’s patent estate, the ability to continue to remain well financed and the cash providing a runway into the first quarter of 2025, and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
Source: Theriva Biologics, Inc.
NEWS -- Scorpius Holdings Announces Removal of NYSE American Trading Suspension; Expected to Resume Normal Trading on August 2, 2024
DURHAM, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today announced that the staff of NYSE Regulation has withdrawn its delisting determination and will be lifting the trading suspension of the Company's common stock on the NYSE American. The NYSE Regulation staff determined that the Company's common stock was now trading above the threshold of low selling price issues as further defined by Section 1003(f)(v) of the NYSE American Company Guide. Scorpius’ common stock is expected to resume trading on the NYSE American on Friday, August 2, 2024, under the symbol "SCPX" and Cusip “42237K 508.”
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, Texas. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding the Common Stock resuming trading on the NYSE American on Friday, August 2, 2024, under the symbol "SCPX." Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to resume trading on Friday, August 2, 2024 and have its Common Stock remain listed and recommence trading on the NYSE American; the Company’s financing needs; its cash balance being sufficient to sustain operations and its ability to raise capital when needed; the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements; regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO; and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website
“Working to Save Lives Together” Theme Highlights Two Decades of Successful Collaboration with the International Medical and Research Communities to Help Patients Survive Life-Threatening Illnesses
PRINCETON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of deadly conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, is proud to announce the launch of its newly redesigned and consolidated website at https://www.cytosorbents.com. The theme of “Working to Save Lives Together” highlights two decades of successful collaboration with the international medical and research communities to continuously refine how our therapies, such as CytoSorb®, ECOS-300CY®, and VetResQ® are being used to help patients survive life-threatening illnesses.
A Modern, Unified Online Presence
The new website, built from the ground up, unifies our corporate and product information into a single, cohesive and comprehensive information hub for healthcare professionals, investors, and other key stakeholders. Visitors will find a streamlined modern design, intuitive navigation, and extensive content on our company, technology, therapies, pipeline that includes DrugSorb™-ATR and HemoDefend-BGA™, clinical studies, investor conferences, and much more.
Key Features of the New Website:
NEWS -- Plus Therapeutics Showcases Leptomeningeal Metastases Programs at 2024 SNO/ASCO Conference
Company to present new data, highlighting progress in its therapeutics and diagnostics programs for Leptomeningeal Metastases
AUSTIN, Texas, July 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) / American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, in Denver, Colorado.
“This year’s SNO/ASCO Metastases conference is a key opportunity for Plus to highlight advancements in our LM therapeutics and diagnostics programs,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “The conference gathers key influencers and clinicians to discuss important topics in the field and we are honored to have multiple opportunities to share our results with the scientific community.”
Events and data presentations include:
Symposium:
The Company will be hosting a symposium titled, “Emerging Novel Diagnostic and Therapeutic Approaches for Leptomeningeal Metastases” on August 8, 2024, at 6:15-7:15 p.m. MDT in the Plaza Ballroom (DEF) of the Sheraton Denver Downtown Hotel. Speakers include:
NEWS -- Scorpius Holdings Set to Launch First Mammalian cGMP Campaign at San Antonio Facility in the 2024 3rd Quarter
DURHAM, N.C., July 24, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced that the Company expects to launch its first cGMP mammalian manufacturing campaign at its San Antonio manufacturing facility in the 3rd quarter of 2024. This milestone highlights the expansion of the Company’s biomanufacturing capabilities, particularly in the field of mammalian cell culture production for advanced biopharmaceuticals.
Scorpius has previously initiated cGMP activities in its microbial facilities, and the commencement of mammalian cGMP campaigns marks a significant development as it opens additional revenue streams for the Company’s CDMO operations. Scorpius boasts a dedicated mammalian cell culture facility with cGMP-compliant controlled cleanrooms illustrating Scorpius' commitment to providing tailored and adaptable manufacturing solutions.
Jeff Wolf, CEO of Scorpius, remarked, “I am extremely proud of what our team has accomplished in a short period of time. Our manufacturing and quality teams have worked exceptionally hard to get our mammalian facilities operational in less than two years, well ahead of the typical timing for such complex buildouts. Scorpius is now extremely well-positioned to support a wide range of early-stage clinical programs."
“Our focus at Scorpius is providing each client the personalized attention and systematic flexibility they deserve. Our facility's design includes cleanrooms with mobile equipment, allowing for easily customized configurations to meet the specific needs of each project. Our strategy is to expand our scope of services as our clients advance their respective programs through clinical development. Looking ahead, Scorpius has already secured bookings for additional cGMP activities in the mammalian building for 2025, demonstrating the demand and confidence in our expanded capabilities,” concluded Mr. Wolf.
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as launching Scorpius’ first cGMP mammalian manufacturing campaign at its San Antonio manufacturing facility in the 3rd quarter of 2024, opening additional revenue streams for Scorpius’ operations, being extremely well-positioned to support a wide range of early-stage clinical programs, expanding the scope of services as Scorpius’ clients advance their respective programs through clinical development. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to launch its first cGMP mammalian manufacturing campaign and open additional revenue streams as planned; expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Thursday, August 1, 2024, at 4:30 p.m. ET
SAN DIEGO, Calif. and CALGARY, Alberta, July 24, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Thursday, August 1, 2024, at 4:30 p.m. ET to discuss a corporate update and financial results for the second quarter 2024.
Conference Call & Webcast
Date: Thursday, August 1, 2024
Time: 4:30 p.m. ET
Dial In – North American Toll-Free: (800) 836-8184
Dial In – International: (646) 357-8785
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 34386
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 34386#.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-second-quarter-financial-results-and-recent-operational-highlights-302204603.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/July2024/24/c1327.html
NEWS -- FuelPositive: Completes On-Farm Commissioning of the First Scalable Green Ammonia Production System and Announces New Manitoba-Based Partnerships
WINNIPEG, Manitoba, July 19, 2024 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company”) is thrilled to announce the completion of on-farm commissioning of its first scalable Green Ammonia production system.
Francisco Mora, FuelPositive's Lead Chemical Engineer, commented, “We are excited to unveil our technology to the world and initiate the production of Green Ammonia. We are virtually ready to activate our system and produce ammonia. Our only setback during commissioning has been related to two on-the-ground certifications specific to Manitoba, which are required before turning the system on fully.”
Ian Clifford, Co-Founder and CEO, explained further, “We are excited and prepared to activate ammonia production in our first on-farm system and demonstrate our groundbreaking technology to the world. Currently, we are awaiting the final go-ahead from the province before proceeding. Unfortunately, our team was inaccurately informed of the completion and timeline of two necessary Manitoba certifications. We have addressed this issue.
While these approvals are essential to comply with Manitoba's requirements and to complete the final activation of the system, we are confident that we are compliant and that obtaining these certifications is a formality. We will continue to advise on this progress.”
Luna Clifford, Co-Founder and CIO, added:
“Fortunately, our team's skill, resourcefulness, and strong connections and advisors in Manitoba have allowed us to address the situation promptly. We have been supported by skilled and reputable Manitoba-based companies that have helped facilitate the company's transition to the province.
Leading mechanical and electrical contractors Wescan and Tri-Star Automation, the engineering firm QPS Evaluation Services Inc., and site safety specialist Quint Services have been pivotal in this process.
These local alliances have facilitated the on-farm commissioning of our first system and have guided us through the final regulatory hurdles, helping minimize delays.
Their invaluable support has helped FuelPositive navigate and adapt to Manitoba's specific on-the-ground requirements, ensuring a smooth and efficient integration.”
Jon Treloar, Mechanical Division Manager of Wescan Construction Services https://wescan-services.com, commented,
“We’re excited about the transformative impact FuelPositive can have on agriculture in Manitoba and beyond. FuelPositive has contracted us to help navigate the specific regulatory landscape of Manitoba.
Our extensive experience in dealing with the Ministry of Labour requirements ensures that FuelPositive has the necessary guidance and that their final "on the ground" approvals are underway.
Additionally, Wescan has provided FuelPositive with highly skilled Manitoba-certified contractors to expedite the approval process and support commissioning the first FP300 unit. These contractors offer critical electrical and mechanical support, helping to accelerate the project timeline.
Manitoba is known for its stringent regulations. However, the good news is that once FuelPositive’s first system is certified as "ready" for Manitoba, the certification process for subsequent systems will be much quicker and largely routine.”
David Thorarinson, Owner and CEO of Tri-Star Automation https://tristarautomation.ca commented,
“Our team at Tri-Star Automation is leveraging its extensive expertise to empower FuelPositive by providing essential electrical contracting, optimizing collaboration with Manitoba Hydro, and consulting on developing cutting-edge mass production capabilities in the province.”
Reagan Coppicus, Owner of Quint Services Ltd. https://quintservices.com, added,
“At Quint Services, we recognize the critical importance of safety planning for FuelPositive’s first-of-its-kind on-farm Green Ammonia manufacturing system and related storage. Our thorough safety and emergency response services ensure that FuelPositive can produce and store Green Ammonia with complete assurance, safeguarding farmers in emergencies. With our expert consulting and dedicated emergency response team, we are committed to helping FuelPositive create a safer and more sustainable future in agriculture.”
FuelPositive is also pleased to share that the Company has received numerous visits from interested farmers, stakeholders, and new association members eager to see the Company’s system in person at the Hiebert’s farm in Sperling.
This interest highlights the excitement and potential FuelPositive’s technology and business model holds for the agricultural sector, particularly for farmers.
Rick Rutherford, a third-generation owner and farmer at Rutherford Farms in Grosse Isle, Manitoba, https://www.rutherfordfarms.ca, commented,
“We have closely followed FuelPositive's groundbreaking projects in Waterloo, Ontario and Sperling, Manitoba.
Excited by their innovative approach, we've eagerly participated in the initial tranche of their current financing round and are now closely monitoring the progress of our investment.
As a near-net-zero-carbon farming operation, one of our most significant challenges has been reducing the carbon footprint of our nitrogen fertilizers.
Integrating FuelPositive’s technologies on our 12,000-acre farm has the potential to propel us into a carbon net-zero reality.
This milestone would be an incredible achievement for us, and it would set a transformative precedent for sustainable agriculture in Canada and worldwide!”
Ian Clifford added, “We’re thrilled by the overwhelmingly positive response and support we've received from farmers, government agencies, and stakeholders across Manitoba since our arrival, resulting in many different site visits throughout July.
It's incredibly humbling to witness the enthusiasm, interest and demand for innovative solutions like ours in the agricultural sector.”
Luna Clifford concludes, “We're eager to produce ammonia on-site. While we have encountered some regulatory delays and are waiting to proceed, we continue to grow our network and promote FuelPositive interests and growth in Manitoba. Our commitment to delivering impactful solutions to farmers remains unwavering.”
About FuelPositive Corporation
FuelPositive is a Canadian technology company dedicated to delivering commercially feasible and sustainable clean technology solutions that follow a circular approach, ensuring the entire lifecycle of our products is environmentally friendly. This includes an on-farm/onsite, containerized Green Ammonia (NH3) production system that effectively eliminates carbon emissions during the production process.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See pre-sale details here: https://fuelpositive.com/sales/.
FuelPositive Corporation is based in Waterloo and Manitoba (Canada) and trades on the TSX Venture Exchange under the symbol NHHH and in the USA on the OTCQB under the symbol NHHHF.
For further information, please contact:
Ian Clifford
Co-Founder, Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
Tel: 416.535.8395
https://www.fuelpositive.com
Jodee Mason
Senior Account Director
Counsel Public Affairs, Inc.
mailto://jmason@counselpa.com
Tel: 204.898.7183
https://www.counselpa.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital Inc.
mailto://et@transcendcapitalinc.com
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including with respect to further testing and implementation of the FP300 system, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided to provide information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
NEWS -- Scorpius Holdings Successfully Executes First cGMP Microbial Batches at San Antonio Facility
Company poised to execute additional cGMP activities throughout the remainder of the year
DURHAM, N.C., July 18, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the successful execution of its first current Good Manufacturing Practice (cGMP) microbial batches at its San Antonio manufacturing facility. This significant milestone marks the beginning of Scorpius’ support for manufacturing programs through clinical manufacturing, with aspirations for future commercial activities.
Scorpius' facilities have already attracted significant interest, resulting in a substantial backlog of client program bookings. This achievement underscores Scorpius' ability to meet the stringent regulatory and client-driven standards essential for the contract manufacturing of microbial biologics. It also highlights the trust and confidence that clients place in its services. Scorpius is poised to execute additional cGMP activities throughout the remainder of the year, reinforcing its commitment to advancing U.S.-based GMP manufacturing capabilities.
Jeff Wolf, CEO of Scorpius Holdings, remarked, "We are thrilled to have successfully completed our first cGMP microbial batches at the San Antonio facility. This milestone is a result of the dedication and collaboration among Scorpius’ manufacturing, process development, quality, and operations teams. The successful execution is a testament to the robust systems we have built and marks another step forward in our commitment to U.S. based cGMP activities for both current and future Scorpius clients."
"The Company remains dedicated to leveraging our advanced capabilities to support our clients' needs and contribute to the advancement of breakthrough therapies. With completion of this milestone, we believe that Scorpius is ready to further solidify its position as a leader in clinical scale microbial manufacturing, offering our clients unparalleled quality and service," concluded Wolf.
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as Scorpius being poised to execute additional cGMP activities throughout the remainder of the year; aspirations for future commercial activities; Scorpius being ready to further solidify its position as a leader in clinical scale microbial manufacturing, offering its clients unparalleled quality and service Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to continue to validate its microbial facilities; expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Scorpius Holdings Announces Reverse Stock Split
DURHAM, N.C., July 17, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today announced that the Company’s Board of Directors approved a 1-for-200 reverse stock split (the “Reverse Stock Split”) of the Company’s common stock (the “Common Stock”), to increase the selling price of the Company’s Common Stock in order to regain compliance with the requirements and policies of the NYSE American. However, there can be no assurance that that the Reverse Stock Split will increase the Company’s stock price sufficiently in order to meet any requirements and policies of the NYSE American.
The Reverse Stock Split will take legal effect at 11:01 P.M. Eastern Time on July 17, 2024, and the Company's Common Stock will open for trading on the OTC Markets on July 18, 2024, on a post-split basis, under the existing ticker symbol "SCPX" but with new CUSIP number 42237K508.
At Scorpius Holdings, Inc’s Annual Meeting of Shareholders (the “Annual Meeting”) held on July 15, 2024, the Company’s stockholders approved a proposal to amend the Company’s certificate of incorporation to effect a reverse stock split of its Common Stock at a ratio of between 1-for-5 to 1-for-200, with the ratio within such range to be determined at the discretion of the Company’s Board. Following the Annual Meeting, the Board approved a final split ratio of 1-for-200. Following the Reverse Stock Split, the ownership percentage of each stockholder will remain unchanged, other than with respect to fractional shares.
Additional details regarding the Company’s Reverse Stock Split can be found in the Current Report on Form 8-K that the Company will file with the SEC.
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, Texas. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding regaining compliance with the requirements and policies of the NYSE American. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to successfully appeal the determination to the Exchange’s Listing Qualifications Panel and have its Common Stock remain listed and recommence trading on the NYSE American; the Company’s financing needs; its cash balance being sufficient to sustain operations and its ability to raise capital when needed; the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements; regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO; and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Realbotix Announces Strategic Partnership with Star Walk Partners
Realbotix Announces Strategic Partnership with Star Walk Partners
Realbotix Corp. (TSX-V: XBOT | Frankfurt Stock Exchange: 76M | OTC: XBOTF) (“Realbotix” or the “Company”), a leading creator of humanoid robotics and relationship-based AI, has acquired a strategic minority interest in Star Walk Partners LLC.
Star Walk is led by Gary Fuhrman, who has a long and distinguished track record of investing and providing assistance to middle market-branded consumer product and media companies. Gary is also the Chairman and CEO of GF Capital. Current and past investments of GF Capital include Tommy Hilfiger, Warner Music Group, Oscar de la Renta, Blue Man Group, 300 Entertainment, GF Sports, Jonathan Adler, and Airborne. As part of the acquisition, Star Walk will assist Realbotix with its product marketing and sales efforts, including expansion into new verticals.
“Our partnership with Star Walk is a pivotal step in our journey to revolutionize the field of humanoid robotics and AI,” said Andrew Kiguel, CEO of Realbotix. “We are confident that this collaboration will significantly enhance our operational strengths and accelerate our growth trajectory.”
“Next-generation, customizable robots with human-like appearance and movement integrated with AI is a large potential market spanning a number of key verticals including entertainment, healthcare, education, and other market segments” said Gary Fuhrman. “We are excited to work with Realbotix to help the company unlock its numerous growth opportunities.”
As consideration for the acquisition, Realbotix will issue to Star Walk an aggregate of 25 million warrants (the “Warrants”) to purchase common shares in the capital of the Company (the “Common Shares”), such Warrants exercisable at six (6) month intervals in seven (7) tranches (the “Tranches”) over a period of five (5) years, with an exercise price of: (a) US$0.15 per Common Share with respect to the issuance of the first 7,500,000 Warrants; and (b) US$0.20 per Common Share with respect to the issuance of the balance of the Warrants. Each Tranche of Warrants will be exercisable for a 24-month window from the date of their issue, subject to the exercise prices noted above. The exercise of the Warrants may result in Star Walk becoming an insider of the Company.
The Company will own a minority, non-controlling membership interest in Star Walk and has obtained conditional approval from the TSX Venture Exchange in connection with the transaction. Star Walk is an arm’s length party to the Company. No broker, agent or finder’s fee is payable in connection with the transaction.
To learn more about Realbotix, visit https://www.realbotix.ai.
About Realbotix
Realbotix creates customizable, human-like robots with AI integration that improve the human experience through learning, connection and play. Manufactured in Nevada, USA, we have built a reputation for having the highest quality humanoid robots and the most realistic silicone skin technology on the market.
We operate in a niche part of the massive robotics and AI sectors: Our robots provide companionship to humans. We achieve this through patented technologies that deliver human-like appearance and movements, and our proprietary companionship AI. In addition, our patented silicone skin technology has versatile uses within our robotic products and within healthcare markets such as prosthetics. We have thousands of customers across more than a hundred countries.
Visit https://Realbotix.AI to learn more.
Keep up-to-date on Realbotix.AI developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as “may”, “will”, “plan”, “expect”, “anticipate”, “estimate”, “intend” and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedarplus.ca. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Realbotix Corp.
Andrew Kiguel, CEO
Email: mailto://contact@realbotix.ai
Jennifer Karkula, Head of Communications
Email: mailto://contact@realbotix.ai
Telephone: 647-578-7490
View source version on businesswire.com: https://www.businesswire.com/news/home/20240710543310/en/
NEWS -- Realbotix Announces Strategic Partnership with Star Walk Partners
Realbotix Announces Strategic Partnership with Star Walk Partners
Realbotix Corp. (TSX-V: XBOT | Frankfurt Stock Exchange: 76M | OTC: XBOTF) (“Realbotix” or the “Company”), a leading creator of humanoid robotics and relationship-based AI, has acquired a strategic minority interest in Star Walk Partners LLC.
Star Walk is led by Gary Fuhrman, who has a long and distinguished track record of investing and providing assistance to middle market-branded consumer product and media companies. Gary is also the Chairman and CEO of GF Capital. Current and past investments of GF Capital include Tommy Hilfiger, Warner Music Group, Oscar de la Renta, Blue Man Group, 300 Entertainment, GF Sports, Jonathan Adler, and Airborne. As part of the acquisition, Star Walk will assist Realbotix with its product marketing and sales efforts, including expansion into new verticals.
“Our partnership with Star Walk is a pivotal step in our journey to revolutionize the field of humanoid robotics and AI,” said Andrew Kiguel, CEO of Realbotix. “We are confident that this collaboration will significantly enhance our operational strengths and accelerate our growth trajectory.”
“Next-generation, customizable robots with human-like appearance and movement integrated with AI is a large potential market spanning a number of key verticals including entertainment, healthcare, education, and other market segments” said Gary Fuhrman. “We are excited to work with Realbotix to help the company unlock its numerous growth opportunities.”
As consideration for the acquisition, Realbotix will issue to Star Walk an aggregate of 25 million warrants (the “Warrants”) to purchase common shares in the capital of the Company (the “Common Shares”), such Warrants exercisable at six (6) month intervals in seven (7) tranches (the “Tranches”) over a period of five (5) years, with an exercise price of: (a) US$0.15 per Common Share with respect to the issuance of the first 7,500,000 Warrants; and (b) US$0.20 per Common Share with respect to the issuance of the balance of the Warrants. Each Tranche of Warrants will be exercisable for a 24-month window from the date of their issue, subject to the exercise prices noted above. The exercise of the Warrants may result in Star Walk becoming an insider of the Company.
The Company will own a minority, non-controlling membership interest in Star Walk and has obtained conditional approval from the TSX Venture Exchange in connection with the transaction. Star Walk is an arm’s length party to the Company. No broker, agent or finder’s fee is payable in connection with the transaction.
To learn more about Realbotix, visit https://www.realbotix.ai.
About Realbotix
Realbotix creates customizable, human-like robots with AI integration that improve the human experience through learning, connection and play. Manufactured in Nevada, USA, we have built a reputation for having the highest quality humanoid robots and the most realistic silicone skin technology on the market.
We operate in a niche part of the massive robotics and AI sectors: Our robots provide companionship to humans. We achieve this through patented technologies that deliver human-like appearance and movements, and our proprietary companionship AI. In addition, our patented silicone skin technology has versatile uses within our robotic products and within healthcare markets such as prosthetics. We have thousands of customers across more than a hundred countries.
Visit https://Realbotix.AI to learn more.
Keep up-to-date on Realbotix.AI developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as “may”, “will”, “plan”, “expect”, “anticipate”, “estimate”, “intend” and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedarplus.ca. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Realbotix Corp.
Andrew Kiguel, CEO
Email: mailto://contact@realbotix.ai
Jennifer Karkula, Head of Communications
Email: mailto://contact@realbotix.ai
Telephone: 647-578-7490
View source version on businesswire.com: https://www.businesswire.com/news/home/20240710543310/en/
NEWS -- Navidea Biopharmaceuticals, Inc. Announces Results of Exploratory Analysis Completed on July 2, 2024
Navidea Biopharmaceuticals, Inc. has completed an exploratory analysis of its Rheumatoid Arthritis Program
COLUMBUS, Ohio, July 03, 2024--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (OTC: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced disappointing results of an exploratory analysis conducted on the Company’s pivotal NAV3-33 clinical trial titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)" (ClinicalTrials.gov Identifier: NCT05246280) the "RA Trial."
The purpose of the exploratory analysis was to optimize the diagnostic performance in support of the methodologies to be applied in the final pivotal trial. The results confirm that intravenous Tc 99m tilmanocept can target and produce reliable images of macrophage activity in RA patients, but that these images do not adequately predict which patients will respond to treatment with an anti-TNF alpha medication.
"We were very surprised and disappointed that the results of the exploratory analysis did not support the hypothesis of an overall accuracy of early treatment response approaching 90%, but rather, the overall accuracy of early treatment response was on average consistently below 70%," said Dr. Michael Blue, Navidea’s Chief Medical Officer. "Results with that predictive value are not indicative of a commercially viable product."
Given these results, Navidea is suspending all activities related to the RA Trial. The Company is pivoting to focus on exploring all opportunities related to the Company’s therapeutic assets.
About Navidea
Navidea Biopharmaceuticals, Inc. (OTC: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward- looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240703199069/en/
Contacts
Investor Relations
Navidea Biopharmaceuticals, Inc.
Craig A. Dais, Chief Financial Officer
mailto://cdais@navidea.com
(614)-822-2322
There's 2 recent patent applications by Novartis that reference Radiogel as an option for radionuclide therapy.
NEWS -- Lineage Cell Therapeutics Added to Membership of 2024 Russell 3000® Index
CARLSBAD, Calif., July 02, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that the Company has been added as a member of the broad-market Russell 3000® Index, effective after the U.S. market opens on July 1, 2024, as part of the 2024 Russell indexes reconstitution. The annual reconstitution of the Russell US indexes captures the 4,000 largest US stocks as of April 30, 2024, ranking them by total market capitalization. Membership in the Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
"We are pleased with Lineage’s continued inclusion within the Russell 3000, which can help continue to expand investor awareness, increase institutional ownership, and provide additional liquidity in our stock," stated Brian M. Culley, Lineage CEO, "This recognition of our progress comes during an exciting time, and we believe that a deeper understanding of Lineage’s near term and longer term strategic objectives can help increase support for our novel and exciting approach to cell transplant medicine."
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. According to data as of the end of December 2023, about $10.5 trillion in assets are benchmarked against the Russell US indexes, which belong to FTSE Russell, a prominent global index provider.
Fiona Bassett, CEO of FTSE Russell, an LSEG Business, comments:
"Russell indexes–now in their 40th year–continue to evolve to reflect the dynamic US economy. Annual rebalancing plays a vital role in establishing accurate benchmarks, ensuring they correctly mirror their designated market segments and remain unbiased in terms of size and style."
For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient's functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the impacts to Lineage as a result of being added to the Russell 3000 Index; and the potential of our cell therapy platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240702244492/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Plus Therapeutics to Present at the Gordon Research Conference Radionuclide Theranostics for the Management of Cancer
Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that Melissa Moore, Ph.D., Vice President, Clinical Research and Development, will give a presentation at 11:30 a.m. EDT at the Gordon Research Conference Radionuclide Theranostics for the Management of Cancer on July 8, 2024 in Newry, Maine.
The presentation will report data from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).
Details of presentations:
Title: Targeted Radiolabeled Nanoliposomes for Rare CNS Cancers: An Update on the
ReSPECT Phase 1/2 Trials
Date : July 8, 2024, 11:30 a.m. EDT
Session: Clinical Trial Updates in Radionuclide Theranostics
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
The day is still young!!!
NEWS -- Vivos Inc. Submits the Application to the FDA for Authority to Initiate Human Clinical Trials
Richland WA, June 28, 2024 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. filed the application for an Investigational Device Exemption (“IDE”).
The filing was an amendment, addressing the FDA comments to our previous application (Q211938/S001). Today’s IDE submission marks our first filing with the FDA following the grant of the FDA Breakthrough Device Designation for the Radiogel™ Precision Radionuclide Therapy. We are appreciative of the improved communication with the FDA since receiving the breakthrough designation. Our IDE filing contained reports on two complex studies, RadioGel® genotoxicity and the retention of RadioGel® at the injection site in VX2 tumors in rabbits. This current IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, we repeated underlying testing to strengthen our answers with current data. Dr. Korenko stated, “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly.”
In closing Dr. Korenko stated, “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.
Dr. Michael Korenko
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
Email: mailto://MKorenko@RadioGel.com
Follow Vivos Inc @VivosIncUSA, Radiogel® and Isopet® on X (Twitter):
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy™ medical device to treat tumors in animals (IsoPet®) and humans (RadioGel®). Using the company's proprietary hydrogel technology, PRnT™ uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel® is a hydrogel liquid containing tiny yttrium-90 phosphate microparticles that may be administered directly into a tumor. The hydrogel is a yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel® also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an outpatient procedure, and the patient may return home without subsequent concern for radiation dose to family members.
University veterinary hospitals use the IsoPet® Solutions division to demonstrate animal cancers' safety and therapeutic effectiveness. Testing on feline sarcoma at Washington State University was completed in 2018, and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019. The Company has obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling, which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices, so no additional approval was required to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel® for treating humans. The Food and Drug Administration advised using different product names to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
MKorenko@VivosInc.com
NEWS -- Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program
Clear path forward on key elements of the planned potential registration-enabling trial in HR+/HER2- metastatic breast cancer
On track to report overall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial in H2 2024
SAN DIEGO and CALGARY, AB, June 27, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, today announced that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.
"Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep's immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options."
Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients."
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot." This allows the anti-tumor immune cells, induced by pelareorep, to attack the cancer.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that we are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options; our belief that the outcome of the meeting with the FDA is an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC; our corporate objective of initiating a registration-enabling trial; our belief that we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year; our belief in the therapeutic potential of pelareorep; our commitment to improving the standard of care and addressing the high unmet medical needs of these patients; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Logo: https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-productive-fda-type-c-meeting-on-its-metastatic-breast-cancer-program-302184357.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2024/27/c9211.html
CEO would like to retire like everyone else,3 billion would be like 7.00 dollars a share, we aren't getting any younger here. FYI I would be happy with 2 billion.