Purple City Labs Introduces OnSight, a Molecular Assay for In-house Testing of Hop Latent Viroid

Purple City Labs Introduces OnSight, a Molecular Assay for In-house Testing of Hop Latent Viroid




Purple City Labs Introduces OnSight, a Molecular Assay for In-house Testing of Hop Latent Viroid

OAKLAND, Calif., Jan. 27, 2023 (GLOBE NEWSWIRE) — Purple City Labs, a plant molecular biology company developing germplasm and technologies for the management of breeding programs and nurseries, is rolling out a Reverse Transcription- Loop Mediated Isothermal Amplification (RT-LAMP) based assay for testing and surveillance of Hop Latent Viroid.

Hop Latent Viroid is the principal viral agent affecting cannabis plants, it has the propensity to spread quickly through a nursery via tools (and likely run-off and insect vectors). Infected plants often appear asymptomatic in a vegetative state only to show symptoms once flowering. It can cause catastrophic damage to a facility with cannabinoid levels and yields reduced by more than 30%.

The assay was custom developed for Purple City Genetics (PCG), a California cannabis breeding company, after they had a disappointing experience with outside testing labs.

“We spent hundreds of thousands of dollars collecting and sending samples to labs without being able to get ahead of this nasty pathogen. Finally we realized that what was available on the market was inappropriate for the problem at hand. We needed to test in-house, frequently with fast turnaround times. So we asked Purple City Labs to develop a test for us. Pretty swiftly we were able to cull sick plants, and after a few generations we have brought our mother block infection rates to zero,” said Purple City Genetics’ founder, Auryn McCafferty.

The OnSight testing platform uses a crude sample preparation, which significantly cuts down cost and time compared to RT-PCR testing. A trained operator is able to test hundreds of samples with same-day results.

The current sensitivity of the molecular reaction, expected to increase in future versions, has been quantified at 375 copies of viroid per microliter. Purple City Labs conducted a number of proficiency tests comparing OnSight with six other commercially available assays, finding it to be as accurate.

“In the field of molecular diagnostics, whether it be Hop Latent Viroid in a nursery or SARS-CoV-2 in a human population, the epidemiological context of the pathogen dictates your testing paradigm. One size does not fit all. We designed OnSight to accommodate high-throughput, rapid testing at an affordable cost. We firmly believe that this approach is the only way for an operation with intensive production such as PCG to tackle and overcome this problem,” said Ali Bektaş, co-founder and CEO of Purple City Labs.

Purple City Labs conducted a successful pilot study to test the feasibility of adapting the system in other facilities, and over a dozen nurseries, cultivators and labs in the US and Canada are early adopters.

“OnSight is an extremely easy and rapid test that has fixed many issues we have experienced when testing our cannabis plants for Hop Latent Viroid. It has removed countless delays and inefficiencies out of the testing equation and replaced them with quick and efficient ways to determine whether a plant is positive or negative for a viroid that spreads quickly in non-symptomatic plants. The program that OnSight offers has allowed us to create a much needed program to keep our facility free of issues and decrease in yield and potency,” said Brent Barnes, VP of Breeding and Cultivation, Co-Founder, Claybourne Co.

The molecular assay is part of a package where PCL scientists advise customers on best practices in their facility, the appropriate equipment needed to run OnSight assays and provide comprehensive training to execute the assay.

For more information on fast, affordable and effective Hop Latent Viroid testing, reach out to Purple City Labs, Inc.

https://labs.purplecitygenetics.eu/

instagram.com/therealpurplecitygenetics/

Purple City Labs, Inc.
(650) 670-0228
onsight@purplecitylabs.com
https://labs.purplecitygenetics.eu/

Achieve Life Sciences Announces Granting of New Hire Inducement Award

Achieve Life Sciences Announces Granting of New Hire Inducement Award




Achieve Life Sciences Announces Granting of New Hire Inducement Award

SEATTLE, Wash and VANCOUVER, British Columbia, Jan. 27, 2023 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that the Company has issued an inducement grant of stock options to a new employee.   

Achieve’s Board of Directors approved the new employment inducement grant to purchase 15,000 shares of Achieve’s common stock with the grant awarded on January 25, 2023. Achieve granted the stock options as a material inducement to the new employee for entering into an employment agreement with Achieve in accordance with Nasdaq Listing Rule 5635(c)(4). 

The stock options approved under the inducement grant were issued pursuant to a stock option agreement on terms substantially similar to Achieve’s 2018 Equity Incentive Plan and have a per share exercise equal to the closing price of Achieve’s common stock on January 25, 2023. The stock options vest over four years, with 25% vesting on the first anniversary of the employee’s start date and 1/36TH of the remaining shares vesting monthly thereafter, subject to the employee’s continued employment on each such date. The stock options have a 10-year term and are subject to the terms and conditions of the stock option agreements.   

About Achieve and Cytisinicline 
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2

In addition, there are nearly 11 million adults in the United States who use e-cigarettes, also known as vaping.3 While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.4 In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.5 Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.6 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.
 
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com.

Investor Relations Contact  
Rich Cockrell  
achv@cg.capital  
(404) 736-3838  

Media Contact  
Glenn Silver 
Glenn.Silver@Finnpartners.com 
(646) 871-8485 

References
1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
2U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
3Cornelius ME, Wang TW, Jamal A, Loretan CG, Neff LJ. Tobacco Product Use Among Adults — United States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:1736–1742. DOI: 10.15585/mmwr.mm6946a4
4Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].
5Gentzke AS, Wang TW, Cornelius M, et al. Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no. SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.
6Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593.

Bright Minds Biosciences Announces Receipt of Nasdaq Notification Letter Regarding Minimum Bid Price Deficiency

Bright Minds Biosciences Announces Receipt of Nasdaq Notification Letter Regarding Minimum Bid Price Deficiency




Bright Minds Biosciences Announces Receipt of Nasdaq Notification Letter Regarding Minimum Bid Price Deficiency

VANCOUVER, British Columbia, Jan. 27, 2023 (GLOBE NEWSWIRE) — Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) (“Bright Minds” or the “Company”) announces that it has received a notification letter (the “Notification Letter”) from the Nasdaq Stock Market LLC (“NASDAQ”) dated January 26, 2023, notifying the Company that due to thirty consecutive business days of closing bid prices for the common shares in the capital of the Company (the “Shares”) being below US$1.00 per Share, Bright Minds is not compliant with the minimum bid price requirement set forth in NASDAQ Listing Rule 5550(a)(2).

The Company has been provided 180 calendar days, being until July 25, 2023 (the “Compliance Period”), to regain compliance, which may be done by having a closing bid price of at least US$1.00 for a minimum of 10 consecutive business days during the Compliance Period.

The receipt of the Notification Letter has no immediate effect on the listing of the Company’s Shares, which will continue to trade uninterrupted on each of the Canadian Securities Exchange and NASDAQ under the symbol “DRUG.” To address the issue, the Company will continuously monitor its closing bid prices between now and July 25, 2023, and evaluate its options to regain compliance with NASDAQ Listing Rule 5550(a)(2) before such date. The Company anticipates resolving the deficiency within the compliance period.

About Bright Minds

Bright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as psilocybin.

Investor Contacts:
Lisa Wilson
E: lwilson@insitecony.com
T: 917-543-9932

Ian McDonald
CEO and Director
E: ian@brightmindsbio.com
T: 917-543-9932

This news release includes certain statements that may be deemed “forward-looking statements”. All statements in this new release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Forward-looking information in this news release includes statements related to future remedies of the Company’s non-compliance with NASDAQ Listing Rule 5550(2)(a), including its continuous monitoring of the closing price of the Shares or related actions that may be taken to regain compliance. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include market prices, continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

Pliant Therapeutics Announces Closing of Upsized Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

Pliant Therapeutics Announces Closing of Upsized Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares




Pliant Therapeutics Announces Closing of Upsized Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

SOUTH SAN FRANCISCO, Calif., Jan. 27, 2023 (GLOBE NEWSWIRE) — Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced the closing of its previously announced upsized underwritten public offering of 9,583,334 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,250,000 additional shares, at a price to the public of $30.00 per share. The aggregate gross proceeds from the offering were approximately $287.5 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Pliant. All shares of common stock were offered by Pliant.

J.P. Morgan and Piper Sandler acted as lead book-running managers for the offering. RBC Capital Markets acted as a book-running manager for the offering. Cantor, Oppenheimer & Co. and H.C. Wainwright & Co. acted as lead managers for the offering.  

Pliant intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and short-term investments, to develop its ongoing and future preclinical and clinical programs including bexotegrast and PLN-101095, further develop its integrin targeting platform, to fund working capital, operating expenses and capital expenditures, and for other general corporate purposes.

The securities were offered by Pliant pursuant to registration statements on Form S-3 (File Nos. 333-257684 and 333-269397) previously filed and declared effective by the Securities and Exchange Commission (the “SEC”). A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained for free from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at prospectus@psc.com; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by email at equityprospectus@rbccm.com.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of Pliant, 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 Pliant Therapeutics, Inc.

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant is advancing its discovery and clinical stage portfolio by applying its deep understanding of fibrosis biology, medicinal chemistry, translational medicine and integrin structure and biology.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements, including statements regarding the anticipated use of net proceeds from the public offering. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to market conditions, the development and commercialization of our product candidates, including any delays in our ongoing or planned preclinical or clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, our reliance on third parties for critical aspects of our development operations, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 1, 2022, as amended, and as updated by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the SEC on November 8, 2022, each available on the SEC’s website at http://www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Investor and Media Contact:

Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com

ZyVersa Therapeutics Reports Inducement Grant to Newly Appointed Chief Medical Officer Under Nasdaq Listing Rule 5635(c)(4)

ZyVersa Therapeutics Reports Inducement Grant to Newly Appointed Chief Medical Officer Under Nasdaq Listing Rule 5635(c)(4)




ZyVersa Therapeutics Reports Inducement Grant to Newly Appointed Chief Medical Officer Under Nasdaq Listing Rule 5635(c)(4)

WESTON, Fla., Jan. 27, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases with high unmet medical needs, today announced the grant of an inducement equity award outside ZyVersa’s 2022 Equity Incentive Plan to its newly appointed Chief Medical Officer and Senior Vice President of Medical Affairs, Dr. Pablo Guzman. The grants were approved by the Compensation Committee of the Board of Directors, effective as of January 26, 2023, as inducements material to Dr. Guzman entering into employment with ZyVersa in accordance with Nasdaq Listing Rule 5635(c)(4).

The inducement grants consisted of a nonqualified stock option to purchase 100,000 shares of common stock. The option has an exercise price of $2.11 per share, the closing price per share of the Company’s common stock as reported by Nasdaq on January 25, 2023. The option has a ten-year term and vests in three equal annual installments commencing on January 26, 2024, subject to Dr. Guzman’s continued service with ZyVersa through the applicable vesting dates.

About ZyVersa Therapeutics, Inc.

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. ZyVersa’s focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. The company’s development pipeline includes phase 2a-ready VAR 200, a cholesterol efflux mediator for treatment of rare kidney disease, focal segmental glomerulosclerosis (FSGS). Other potential indications for VAR 200 include Alport syndrome and diabetic kidney disease. ZyVersa’s development pipeline also includes a novel inflammasome ASC inhibitor, IC 100, to control damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com. 

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:

Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.

Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
Dschemelia@tiberend.com
609-468-9325

Jasper Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

Jasper Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares




Jasper Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

REDWOOD CITY, Calif., Jan. 27, 2023 (GLOBE NEWSWIRE) — Jasper Therapeutics, Inc. (Nasdaq: JSPR) (“Jasper”), a biotechnology company focused on developing novel antibody therapies targeting c-Kit (CD117) to address diseases such as chronic spontaneous urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) as well as novel stem cell transplant conditioning regimes, announced today the closing of its previously announced underwritten public offering of 69,000,000 shares of its common stock, at a public offering price of $1.50 per share, which includes the exercise in full by the underwriters of their option to purchase up to 9,000,000 additional shares of common stock. The gross proceeds from this offering are approximately $103.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by Jasper.

Credit Suisse Securities (USA) LLC and William Blair & Company, L.L.C. acted as the active book-running managers for the offering. Oppenheimer & Co. Inc. acted as a passive book-running manager for the offering.

The securities described above were offered by Jasper pursuant to an effective “shelf” registration statement on Form S-3 (File No. 333-267777) previously filed with the Securities and Exchange Commission (the “SEC”) on October 7, 2022 and declared effective by the SEC on October 18, 2022. A final prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, by calling toll-free (800) 221-1037 or by emailing newyork.prospectus@credit-suisse.com, William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by calling toll-free (800) 621-0687, or by emailing prospectus@williamblair.com or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Jasper

Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) and as a conditioning agent for stem cell transplants for rare diseases such as sickle cell disease (SCD), Fanconi anemia (FA) and severe combined immunodeficiency (SCID). To date, briquilimab has a demonstrated efficacy and safety profile in over 130 dosed subjects and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, acute myeloid leukemia (AML), MDS, FA, and SCD. In addition, briquilimab is being advanced as a transformational non-genotoxic conditioning agent for gene therapy.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions and our ability to satisfy closing conditions applicable to the offering, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, and the final prospectus supplement and the accompanying prospectus related to the public offering filed with the SEC. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contacts:

John Mullaly (investors)
LifeSci Advisors
617-429-3548
jmullaly@lifesciadvisors.com

Jeet Mahal (investors)
Jasper Therapeutics
650-549-1403
jmahal@jaspertherapeutics.com

Lauren Barbiero (media)
Real Chemistry
646-564-2156
lbarbiero@realchemistry.com

Extraordinary General Meeting of February 15, 2023: Notice of publication of the preparatory documents

Extraordinary General Meeting of February 15, 2023: Notice of publication of the preparatory documents




Extraordinary General Meeting of February 15, 2023: Notice of publication of the preparatory documents

Extraordinary General Meeting of February 15, 2023: Notice of publication of the preparatory documents

Paris, France, January 27, 2023 – 6.00 pm CET – Pixium Vision SA (Euronext Growth Paris – FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, informs its shareholders that an Extraordinary General Meeting of the Company will be held on Wednesday February 15, 2023, at 2.00 pm CET at the headquarter of Pixium Vision, 74 rue du faubourg Saint Antoine in Paris (75012).

The prior notice of the Extraordinary General Meeting containing the agenda and the draft resolutions presented by the Board of Directors for agreement by the shareholders was published in the BALO n°5 (Bulletin des Annonces Légales Obligatoires) on January 11, 2023 and the convening notice was published in the BALO n°12 on January 27, 2023 and in the Affiches Parisiennes (legal newspaper).

The information regarding the Extraordinary General Meeting mentioned in article R. 225-83 of the French Commercial Code can be found as of today on the Company’s website www.pixium-vision.com, under « Investors », « Shareholder’s General Meeting ».

The documents and information mentioned in articles R.225-81 and R.225-83 of the French Commercial Code can be sent to shareholders upon request to the Company.

Shareholders will also be able to consult the documents at the Company’s registered office located in Paris (75012), 74, rue du Faubourg Saint Antoine, during 15 days prior to the General Meeting.

About Pixium Vision

Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, PA. The Company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.

For more information: http://www.pixium-vision.com/fr

Follow us on @PixiumVision; www.facebook.com/pixiumvision

               www.linkedin.com/company/pixium-vision  

Contacts

Pixium Vision
Offer Nonhoff
Chief Financial Officer
investors@pixium-vision.com
+33 1 76 21 47 68
Media Relations

LifeSci Advisors
Sophie Baumont
sophie@lifesciadvisors.com
+33 6 27 74 74 49

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
gvanrenterghem@lifesciadvisors.com
+41 76 735 01 31

 

 

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Avenue Therapeutics Announces $3.25 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules

Avenue Therapeutics Announces $3.25 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules




Avenue Therapeutics Announces $3.25 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules

MIAMI, Jan. 27, 2023 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, today announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale of 1,940,299 shares of common stock and pre-funded warrants to acquire common stock in a registered direct offering. In a concurrent private placement, the company also agreed to issue to the same investor a total of 1,940,299 warrants to purchase up to one share of common stock each at an exercise price of $1.55 per share. The private placement warrants will be exercisable immediately subject to registration and will have a 3-year term from the initial exercise date. Aggregate gross proceeds to the Company of both transactions are expected to be approximately $3.25 million. The transactions are expected to close on or about January 31, 2023, subject to the satisfaction of customary closing conditions.

The purchase price of each share is $1.55. The purchase price of each pre-funded warrant is $1.5499 with an exercise price of $0.0001. The purchase price of each warrant is $0.125 with an exercise price of $1.55. The entire transaction has been priced at the market under Nasdaq rules.

Avenue expects to use the net proceeds from the offering, together with its existing cash, for general corporate purposes and working capital.

Aegis Capital Corp. is acting as Exclusive Placement Agent for the offering.

The registered direct offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-261520) previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on December 10, 2021. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, by contacting Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010.

The offer and sale of the securities in the private placement are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investor, the Company has agreed to file one or more registration statements with the SEC covering the resale of the common stock and the shares issuable upon exercise of the pre-funded warrants and warrants.

Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Avenue Therapeutics
Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases. Avenue is headquartered in Miami, Florida and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO).

Forward-Looking Statements
This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: expectations for increases or decreases in expenses; expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidate or any other products we may acquire or in-license; our use of clinical research centers and other contractors; expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities; expectations for generating revenue or becoming profitable on a sustained basis; expectations or ability to enter into marketing and other partnership agreements; expectations or ability to enter into product acquisition and in-licensing transactions; expectations or ability to build our own commercial infrastructure to manufacture, market and sell our product candidate; acceptance of our products by doctors, patients or payors; our ability to compete against other companies and research institutions; our ability to secure adequate protection for our intellectual property; our ability to attract and retain key personnel; availability of reimbursement for our products; estimates of the sufficiency of our existing cash and cash equivalents and investments to finance our operating requirements, including expectations regarding the value and liquidity of our investments; the volatility of our stock price; expected losses expectations for future capital requirements; uncertainty around the integration of the Baergic Bio acquisition; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors.

Contact:
Jaclyn Jaffe
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com

Savista Receives HFMA Peer Review Designation

Savista Receives HFMA Peer Review Designation




Savista Receives HFMA Peer Review Designation

CHICAGO, Jan. 27, 2023 (GLOBE NEWSWIRE) — The Healthcare Financial Management Association (HFMA) recently reviewed Savista’s revenue cycle services using the Peer Review process. After undergoing the rigorous review, Savista has been awarded the “Peer Reviewed by HFMA®” designation.

Savista has delivered revenue cycle management services to healthcare providers – including healthcare systems, community hospitals, and physician groups – for more than 30 years. The company works alongside healthcare organizations to understand their challenges and finds the right-sized solution, offering audit and assessments, and staffing in areas of Eligibility and Enrollment, CDM, Coding, AR and more. Savista touts one of the most highly trained workforces in the industry with an average of 7.5 years of experience and more than 20+ accreditations including Epic certified trainers. Savista incorporates its clients’ existing software into their processes, eliminating the need for additional costly tech investments.

Key findings from HFMA Peer Review evaluation include:

  • 100 percent of respondents agreed Savista meets expectations.
  • 96 percent said Savista satisfies industry needs.
  • 96 percent feel Savista is easy to partner with.

“We are honored that our revenue cycle services have met the requirements of the Peer Review process, the most rigorous and prestigious in the industry,” said Jan Grimm, CEO of Savista. “This designation is a testament of our dedication to the healthcare industry and commitment to our clients’ success. We are excited to continue to provide new and innovative ways to drive results for our clients across the country.”

HFMA’s Peer Review process provides healthcare financial managers with an objective, third-party evaluation of business solutions used in the healthcare workplace. The rigorous, 11-step process includes a Peer Review panel review composed of current customers, prospects who have not made a purchase, and industry experts. The Peer Review status of the healthcare business solution and its performance claims are based on effectiveness, quality and usability, price, value, and customer and technical support.

“We’re pleased to have Savista achieve their HFMA Peer Reviewed designation,” said HFMA President and CEO Joseph J. Fifer, FHFMA, CPA. “The HFMA Peer Review process assures our members, through a rigorous evaluation, that the reviewed healthcare business solution meets an objective, third-party assessment of overall effectiveness, quality, and value.”

About HFMA  
The Healthcare Financial Management Association (HFMA) equips its more than 96,000 members nationwide to navigate a complex healthcare landscape. Finance professionals in the full range of work settings, including hospitals, health systems, physician practices and health plans, trust HFMA to provide the guidance and tools to help them lead their organizations, and the industry, forward. HFMA is a not-for-profit, nonpartisan organization that advances healthcare by collaborating with other key stakeholders to address industry challenges and providing guidance, education, practical tools and solutions, and thought leadership. We lead the financial management of healthcare.

About Savista
Savista is a prominent provider of healthcare revenue cycle management services, partnering with hospitals, systems, physician practices and ambulatory surgery centers for more than 30 years. The company solves revenue cycle challenges through its comprehensive audits and assessments and expert staffing solutions that span eligibility and enrollment, CDM, coding, AR and more. Its global organization delivers custom solutions to more than 300 clients at 770+ facilities across 49 states. To learn more about Savista please visit SavistaRCM.com.

Press inquiries should be directed to:  

Brad Dennison    
Healthcare Financial Management Association  
(708) 492-3385
bdennison@hfma.org

Kim Wiethorn    
Savista
(513) 884-7597
kim.wiethorn@savistarcm.com

Spark Therapeutics Enters Into Strategic Collaboration with Neurochase for Use of Proprietary Delivery Technology for CNS Disorders

Spark Therapeutics Enters Into Strategic Collaboration with Neurochase for Use of Proprietary Delivery Technology for CNS Disorders




Spark Therapeutics Enters Into Strategic Collaboration with Neurochase for Use of Proprietary Delivery Technology for CNS Disorders

PHILADELPHIA, Jan. 27, 2023 (GLOBE NEWSWIRE) — Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, and Neurochase, a company specializing in the development of scalable therapeutic strategies and enabling technology for direct delivery to the central nervous system (CNS), today announced a strategic collaboration to develop Neurochase’s proprietary delivery technology for use with selected gene therapies for rare diseases in CNS. Through this collaboration, Neurochase will bring their deep expertise in direct drug delivery technology to Spark’s leading AAV platform.

“There continues to be high unmet medical need in treating CNS disorders, and at Spark we see the significant potential of gene therapy to provide new treatment options for patients,” said Federico Mingozzi, Chief Science & Technology Officer, Spark Therapeutics. “Neurological conditions are known to be challenging to target and treat, and we look forward to collaborating with Neurochase toward our goal in improving delivery of AAV-gene therapies to the brain. Leveraging our combined expertise further supports Spark’s ongoing research and development of gene therapies for diseases affecting the CNS, like Huntington’s Disease.”

Neurochase is developing a proprietary drug delivery system and this collaboration enables Spark to develop selected gene therapies for CNS disorders using the Neurochase technology, which aims to improve targeted delivery of AAV gene therapy to neural structures using the method of Convection Enhanced Delivery (CED).

“Applying CED-based delivery systems for AAV gene therapies is an emerging strategy for the treatment of neurological disorders,” said Sharon Kane, CEO, Neurochase. “Advanced delivery systems for AAV gene therapies are promising techniques to allow targeted delivery past the blood-brain barrier with the ability to achieve therapeutic drug concentrations. This collaboration with Spark is an important milestone in our company’s work to improve outcomes for patients and extend tolerability of therapies for central nervous system disorders, including novel gene therapies.”

About Spark Therapeutics
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases. At Spark, a member of the Roche Group, we see the path to a world where no life is limited by genetic disease. For more information, visit www.sparktx.com, and follow us on Twitter and LinkedIn.

About Neurochase
Neurochase, founded by Professor Steven Gill, aims to bring transformative therapies to patients with neurological diseases using state of the art technology. Neurochase specializes in direct drug delivery to the CNS and provides globally scalable treatment strategies and solutions for the pharmaceutical and biotech industry. Neurochase Ltd. is a Registered Company Number 12428919; www.neurochase.com.

Media Contact:
Wendy Kouba
communications@sparktx.com
(267) 583-8482