Pii Expands Prefilled Syringe Services with $3.6M Investment in Capacity and Technology Upgrades




Pii Expands Prefilled Syringe Services with $3.6M Investment in Capacity and Technology Upgrades

New Capabilities Simplify Supply Chain, Reduce Lead Times, and Enhance Quality Control for Biopharmaceutical Customers

HUNT VALLEY, Md.–(BUSINESS WIRE)–Pharmaceutics International, Inc. (Pii), a leading contract development and manufacturing organization (CDMO), has announced a significant expansion of its prefilled syringe (PFS) capabilities with a $3.6 million investment in advanced labeling, fill/finish, and automated visual inspection technologies. This development reflects Pii’s commitment to supporting pharmaceutical and biotech companies with end-to-end, streamlined solutions for drug manufacturing and supply chain efficiency.

Driven by the rising demand for prefilled syringe solutions in the pharmaceutical and biotech industries, Pii’s investment includes a state-of-the-art Optima syringe labeler and Antares automated visual inspection (AVI) system. These additions enable Pii to offer integrated fill/finish and labeling services for PFS, simplifying the supply chain and reducing the time required to bring critical medicines to market.

“With this expansion, Pii strengthens its role as a comprehensive partner, allowing clients to achieve faster time-to-market by managing every step of the PFS process,” said John Fowler, Chief Executive Officer at Pii. “Our streamlined approach will support customers in optimizing both cost and quality, meeting stringent regulatory demands, and ultimately improving patient access to essential therapies.”

The Optima syringe labeler, currently being installed, will be fully operational for client use by late first half / early second half of 2025. This equipment automates essential processes, including syringe labeling, plunger insertion, and safety device integration. By combining fill/finish, automated visual inspection and labeling within Pii, customers minimize the need for multiple contract organizations, reducing logistical and regulatory complexities while streamlining product delivery timelines which is critical for time-sensitive injectables. A unified approach to fill/finish and labeling ensures rigorous quality control across all production stages, minimizing the risk of errors.

Pii’s new AVI technology from Antares, expected to be client-ready by Q3 2025, further enhances quality and compliance by automating the inspection process. This system detects particles, air bubbles, cracks, and fill-level discrepancies with unmatched precision, ensuring consistent product safety and reliability. The AVI system’s high-throughput inspection capability reduces the dependence on manual inspections and improves turnaround times for large-scale production. It also supports stringent regulatory requirements by documenting inspection data for quality analysis and traceability, crucial for FDA and other global regulatory standards.

Pii’s commitment to innovation and patient-centric solutions is central to this investment, aligning with industry trends toward self-administered therapies and ready-to-use delivery formats. By integrating advanced PFS capabilities with a comprehensive quality management system, Pii provides an efficient, reliable manufacturing solution for customers, particularly small and mid-sized pharmaceutical companies aiming for rapid clinical trials or market entry.

About Pii

Pharmaceutics International, Inc. (Pii) is a leading Contract Development and Manufacturing Organization (CDMO) that provides comprehensive solutions for aseptic and oral dosage forms. Founded in 1994 by Dr. Syed Abidi, a pioneering formulation scientist, Pii has over 30 years of experience handling complex formulations, potent compounds, and controlled substances. Based in Hunt Valley, MD, Pii’s capabilities include lyophilization, high potency isolation, and robotic filling. Our expert teams ensure the highest quality and safety standards, supporting small to medium-volume projects with scalable solutions and unmatched flexibility. Committed to client-centric drug development, Pii’s mission is to enhance quality of life through innovative and high-quality pharmaceuticals. Discover more about our services and how we can support your projects at www.pharm-int.com.

Contacts

Josie Zohny

Clarity Quest Marketing

josie@clarityqst.com
877-887-7611

Entrepreneur Training Gets a Boost Through Collaboration Between ABIC and CETAC-WEST




Entrepreneur Training Gets a Boost Through Collaboration Between ABIC and CETAC-WEST

SASKATOON, Saskatchewan–(BUSINESS WIRE)–#agrifood–Entrepreneurs will have increased access to training thanks to a collaboration between the Agricultural Bioscience Innovation Centre (ABIC) and CETAC-WEST. A new agreement between the organizations will allow donations made to the ABIC Foundation to be designated to support CETAC’s entrepreneur programs.

ABIC is a charitable organization managed by Ag-West Bio whose goal is to promote science as a powerful tool for addressing global challenges. ABIC programs include educational events and training for entrepreneurs.

CETAC is a not-for-profit that supports small to medium-sized enterprises in Saskatchewan and Alberta to commercialize environmental and clean technologies within the energy and agriculture sectors. CETAC’s flagship event is its “Entrepreneur to CEO” workshop, an intensive five-day program where entrepreneurs learn business fundamentals and develop practical strategies to successfully deliver environmental solutions to market. CETAC draws on the expertise of over 85 mentors who are currently running or have sold successful businesses.

Brent Zettl is president and CEO of Zyus Life Sciences and serves as chair of CETAC-WEST. He says successful businesspeople are often looking to give back to the organizations that helped them in the early stages of their career, and this is a great opportunity. “We want them to know that by donating to ABIC they can help support CETAC’s unique and effective training programs for early entrepreneurs. CETAC doesn’t pick winners – we build them.”

Karen Churchill, president and CEO of Ag-West Bio, says “As well as being excited about the prospect of increasing training access for entrepreneurs, this is a great opportunity to fulfill ABIC’s mandate and raise the profile of the charity. This collaboration will make both organizations more effective. I am certain this is just the start of a long-term, successful partnership between two like-minded organizations.”

About CETAC-WEST

Founded in 1993, CETAC provides mentoring programs and services to help clients learn management, market and financial concepts and skills, to develop and execute strategies needed to successfully commercialize innovations and prepare to receive and manage funding and investment. Clients range from concept-stage innovators to established SMEs focused on gaining market traction and managing growth. www.cetac.ca

About ABIC

The ABIC Foundation is a registered charity managed by Ag-West Bio, Saskatchewan’s bioscience industry association. ABIC’s vision is “creating value in agriculture, food, health, energy, and bio-based industries for the benefit of humankind.” ABIC programs include the Beyond Entrepreneurship training program and the ABIC Speaker Series. ABIC also provides funding for Ag-West Bio’s Investment Bootcamp. www.agwest.sk.ca/abic-ca

Contacts

Jackie Robin

Communications Director

Ag-West Bio

jackie.robin@agwest.sk.ca
306 229-0391

Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose




Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose

− Single Dose of Nucresiran 300mg or Higher Led to Rapid Knockdown of Mean TTR Levels of Greater than 90% by Day 15 that was Sustained at Six Months −

− At These Doses, Peak Reduction of Mean TTR Levels of Greater than 96% were Achieved by Day 29 −

− Data Support Potential for Biannual or Annual Subcutaneous Dosing, Representing a New Paradigm in the Treatment of ATTR Amyloidosis −

− Encouraging Safety and Tolerability Observed −

− Alnylam Continues to Expect to Share Phase 3 Development Plans in Q1 2025 –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the presentation of new results from its Phase 1 study of nucresiran (formerly ALN-TTRsc04), a next-generation RNAi therapeutic in development for the treatment of transthyretin (ATTR) amyloidosis. The data were presented in an oral session at the American Heart Association Scientific Sessions 2024 in Chicago.

These new results demonstrated that a single dose of nucresiran at 300 mg or higher led to rapid knockdown of serum TTR with low inter-patient variability, with mean reductions of greater than 90% from baseline achieved at Day 15 and sustained through at least Day 180. At these doses, peak reduction of mean TTR levels of greater than 96% were achieved by Day 29. Furthermore, serum TTR levels remained substantially reduced at Day 360 with a mean reduction of greater than 70% after a single 300 mg dose. Day 360 results are not yet available for the 600 mg and 900 mg dose cohorts. All doses of nucresiran have been well tolerated to date.

“We are very excited by these new Phase 1 data with nucresiran, our next-generation TTR-targeting RNAi therapeutic, which demonstrated that a single dose of ≥300 mg achieved rapid knockdown of TTR greater than 90% from Day 15 that was sustained to at least six months,” said Pushkal Garg, M.D., Chief Medical Officer, Alnylam. “Furthermore, we are encouraged by the potential of nucresiran to reduce interpatient variability in TTR lowering. Nucresiran utilizes our IKARIA platform, which has now demonstrated the potential to achieve durability supportive of biannual or annual dosing, representing a potential new paradigm in the treatment of ATTR amyloidosis. Importantly, nucresiran has been well tolerated at all dose levels tested to date. We look forward to sharing Phase 3 development plans in the first quarter of 2025.”

The ongoing Phase 1 dose-finding study evaluated the safety, as well as pharmacodynamics and pharmacokinetics, of single doses of nucresiran in healthy subjects. As previously presented at Alnylam’s R&D Day in December 2023, a single dose of nucresiran led to rapid knockdown of serum TTR that was highly durable.

In subjects receiving a single 300 mg dose of nucresiran, mean serum TTR reduction of 90.3% was observed at Day 15, 96.5% at Day 29, and 92.6% at Day 180. At Day 360, mean serum TTR Reduction was 71.12%. In subjects receiving a single 600 mg dose, mean serum TTR reduction of 95.0% was observed at Day 15, 97.8% at Day 29, and 96.0% at Day 180. In subjects receiving a single 900 mg dose, mean serum TTR reduction of 91.7% was observed at Day 15, 96.7% at Day 29, and 94.2% at Day 180. As of the data cutoff date, TTR knockdown levels at Day 360 were not available for either the 600 mg or 900 mg cohort.

There has been low inter-patient variability in the TTR reduction observed; at Day 29, TTR reduction ranged from 96.0 – 96.7% in the 300 mg cohort, 96.6 – 98.6% in the 600 mg cohort, and 96.0 – 97.3% in the 900 mg cohort.

In the study, nucresiran has been well tolerated at all tested doses. The majority of adverse events across doses have been mild and none have been considered to be related to treatment. There have been no injection site reactions and no safety signals identified, including no liver-related signals.

Phase 1 Study Design

The Phase 1 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of nucresiran in healthy adult subjects. The study enrolled 48 healthy adult subjects randomized 3:1 to receive a single ascending dose of 5, 25, 100, 300, 600, or 900 mg of nucresiran or placebo. The primary endpoint of the study is safety and secondary endpoints include the change from baseline in serum TTR over time, as well as characterization of plasma and urine pharmacokinetics (PK) of nucresiran.

About Nucresiran

Nucresiran is an investigational RNAi therapeutic in development to deliver rapid knockdown of mutant and wild-type transthyretin (TTR) and address the underlying cause of transthyretin (ATTR) amyloidosis. As part of Alnylam’s proprietary IKARIA™ platform, nucresiran has the potential to achieve deeper and more durable rapid knockdown of TTR, allowing for less frequent dosing. The safety and efficacy of nucresiran have not been established or evaluated by the FDA, EMA or any other health authority.

About ATTR

Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by misfolded transthyretin (TTR) proteins, which accumulate as amyloid deposits in various parts of the body, including the nerves, heart and gastrointestinal tract. Patients may present with polyneuropathy, cardiomyopathy or both manifestations of disease. There are two different forms of ATTR – hereditary ATTR (hATTR), which is caused by a TTR gene variant and affects approximately 50,000 people worldwide, and wild-type ATTR (wtATTR), which occurs without a TTR gene variant and impacts an estimated 200,000-300,000 people worldwide.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors that encode for disease-causing or disease pathway proteins – thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on X (formerly Twitter) at @Alnylam, or on LinkedIn, Facebook, or Instagram.

Alnylam Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, the potential for nucresiran to achieve durability supportive of biannual or annual dosing and to represent a new paradigm in the treatment of ATTR amyloidosis; the potential to reduce interpatient variability in TTR lowering with nucresiran; and the timing of Alnylam’s release of Phase 3 development plans for nucresiran should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to: Alnylam’s ability to successfully execute on its “Alnylam P5x25” strategy; Alnylam’s ability to successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates; actions or advice of regulatory agencies and Alnylam’s ability to obtain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; successfully launching, marketing and selling Alnylam’s approved products globally; and any delays, interruptions or failures in the manufacture and supply of Alnylam’s product candidates or its marketed products; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s 2023 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam’s subsequent Quarterly Reports on Form 10-Q and in its other SEC filings. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

Contacts

Alnylam Pharmaceuticals, Inc.
Christine Regan Lindenboom

(Investors and Media)

+1-617-682-4340

Josh Brodsky

(Investors)

+1-617-551-8276

Dante Genomics to Launch Generative AI Features in Dante Labs Whole Genome Platform




Dante Genomics to Launch Generative AI Features in Dante Labs Whole Genome Platform

Leading Genomics Information Company brings new innovation to genomics interpretation and consultation, in its mission to enhance the utility of the genome

NEW YORK–(BUSINESS WIRE)–Dante Genomics, a global leader in genomics and personalized medicine, announced today that it will begin integrating Generative AI features into its first product, the Dante Labs Whole Genome platform. This milestone represents a significant step forward in the company’s mission to make genomic data more actionable and accessible for both researchers and individuals.

“Generative AI cannot be a black box in genomics and diagnostics,” said Andrea Riposati, CEO and co-founder of Dante Genomics. “We are taking the approach of autopilots on airplanes, supporting the human pilot to make important more informed decisions.”

The integration of Generative AI is the result of months of rigorous development and testing, ensuring that the technology meets the highest standards of accuracy and reliability in genomic interpretation. The initiative aligns with Dante Genomics’ broader vision to provide scalable, user-friendly tools for decoding the complexities of the human genome.

A Generative AI Revolution in Genomics

The new Generative AI features are designed to transform the way genomic data is interpreted:

• Interactive Features: ability to explore the genome with interactive features.
• Advanced Data Processing: Generative AI significantly reduces processing times, delivering actionable insights in record time.
• Personalized Insights: Users will benefit from AI-powered narrative reports that make complex genomic information understandable and meaningful.
• Medical Database: The AI integration supports diagnostic accuracy by identifying patterns not possible with traditional methods.
• Scalable Innovation: Designed to meet the needs of individuals, researchers, and healthcare providers, the platform’s AI tools adapt to diverse use cases.

Commitment to Quality and Impact

This announcement builds on Dante Genomics’ history of excellence in genomics. The company remains steadfast in its commitment to quality, having achieved multiple certifications for its technologies and adhering to stringent international standards. The Generative AI integration reflects the company’s continued investment in technologies that make a tangible difference in people’s lives.

The updated Dante Labs Whole Genome platform with Generative AI features will be available globally starting Q1 2025, with early access offered to select customers.

Contacts

Laura Rossi

media@dantelabs.com
+39 0862 191 0671

3rd Philadelphia Jury Finds in Favor of Monsanto in Roundup Trial




3rd Philadelphia Jury Finds in Favor of Monsanto in Roundup Trial

Womack verdict marks 15^th favorable outcome in last 22 trials for the Company

WHIPPANY, N.J.–(BUSINESS WIRE)–Today, the jury reached a verdict in favor of Monsanto in the Womack Roundup™ product liability trial before Judge Michael Erdos in the Philadelphia Court of Common Pleas.

In response to the decision, Monsanto issued the following statement:

“The jury’s verdict in favor of the Company marks the 15^th favorable outcome in the last 22 trials, including three in the PCCP, and validates the Company’s strategy of taking cases to trial based on strong scientific and regulatory evidence. The verdict is consistent with the overwhelming weight of scientific evidence and the consensus of regulatory bodies and their scientific assessments worldwide supporting the safety of glyphosate-based herbicides. While we have great sympathy for anyone who suffers a loss or injury, the science proves that Roundup™ is safe to use and not carcinogenic.

“The Company has been clear that the cross-cutting state-based failure to warn claim in this and other cases in the Roundup litigation is preempted by federal law consistent with the Schaffner decision by the Third Circuit Court of Appeals. This decision created a circuit split within the federal courts that warrants review by the U.S. Supreme Court. The Company is currently evaluating the cases which would present the best opportunity for review. The Company will file a petition for certiorari in or before 2025, and if granted, the Supreme Court would decide the case during its 2025-2026 session.

“Additionally, outside the courtroom, we will continue supporting legislation at the state and federal level alongside hundreds of agricultural organizations to ensure that any pesticide reviewed and registered by the U.S. EPA – and sold under a label consistent with the EPA’s determinations – is sufficient to satisfy requirements for health and safety warnings. Without legislative certainty, the litigation industry will continue to target crop protection tools that have been deemed safe by experts at the U.S. EPA.

“We continue to stand fully behind the safety of Roundup™ products – critical tools that farmers rely on to produce affordable food and feed the world.”

Contacts

Brian Leake

(314) 370.3285

Alpha Cognition Announces Financial Results for the Second Quarter and Six Months Ended June 2024 and Provides Corporate Update




Alpha Cognition Announces Financial Results for the Second Quarter and Six Months Ended June 2024 and Provides Corporate Update

VANCOUVER, British Columbia–(BUSINESS WIRE)–Alpha Cognition Inc. (NASDAQ: ACOG) (CSE: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the second quarter and six months ended September 30, 2024, and provided a corporate update.

“The FDA approval of ZUNVEYL represents an important breakthrough for patients with Alzheimer’s disease. Alpha Cognition is focused on commercial preparation in the US market and ex-US licensing opportunities to bring this important therapy to market. The team is adding important expertise in marketing, sales, product reimbursement, and medical to bring ZUNVEYL to patients in Q1, 2025” said Michael McFadden, the Company’s Chief Executive Officer.

Third Quarter 2024 Business Accomplishments and Corporate Highlights

• The Company raised $4.5M gross proceeds in a bridge financing. Use of proceeds will be to build commercial supply and prepare for commercialization.

• Manufacturing stability tests were successful, which will extend the commercial shelf life of ZUNVEYL to 24 months.

• The Company continued progress in a pre-clinical study in partnership with Seattle Institute for Biomedical and Clinical Research to assess ALPHA-1062 intra nasal’s reduction of behavioral and functional deficits and brain-wide burden of neuropathology following single or multiple blasts compared to placebo and sham. The Company expects the results of this study in the fourth quarter.

• The Company completed preparation to list on the NASDAQ exchange, filing an S1, securing banking partner to complete a necessary capital raise to fund it’s commercialization strategy.

• The Company advanced commercialization preparation for our Q1 2025 launch into the Long-Term Care (“LTC”) market segment. The acetylcholinesterase inhibitor prescription market in the U.S. from the LTC market is large, representing 36% of the over 11 million prescriptions filled in pharmacies each year and is characterized by both patient and physician dissatisfaction.

“The company is excited to launch ZUNVEYL and bring this much-needed treatment option to patients suffering from Alzheimer’s disease. The team is working diligently to prepare for this launch, ensuring that healthcare providers have the information and patients have the resources and support they need. ZUNVEYL offers dual-action benefits with the established efficacy of galantamine and no insomnia. It was uniquely designed to bypass the gut with the potential of minimizing GI side effects. We believe that ZUNVEYL’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease. The team is preparing for a successful rollout and broad accessibility for ZUNVEYL” said Lauren D’Angelo, the company’s Chief Operating Officer.

Financial Highlights for Third Quarter and Nine Months ended September 30, 2024 (Expressed in United States Dollars and prepared in conformity with U.S. Generally Accepted Accounting Standards) (Unaudited)

• Research and development (R&D) expenses were $1.0 million for the three months ended September 30, 2024, and $2.9 million for the nine months ended September 30, 2024, compared to $1.4 million and $3.8 million in the same periods in 2023, respectively. R&D expenses decreased from the prior year primarily due to the completion of the main clinical trails for ZUNVEYL in AD and the majority of the NDA filing expenditures having been incurred during 2023.

• General and administrative (G&A), excluding non-cash expenses relating to accretion, amortization, depreciation, and share-based compensation, were $1.2 million for the three months ended September 30, 2024, and $5.7 million for the nine months ended September 30, 2024, compared to $0.8 million and $2.2 million in the same periods of 2023 respectively. The increases in G&A expenses for both the three and the nine months ended September 30, 2024, compared to the same periods in 2023 was primarily related to increased consulting fee costs, which included $2.3 million recognized for shares issued for services under the Spartan Capital consulting agreement, management fees and salaries and professional fees.

• Share-based compensation included in G&A was $0.1 million for the three months ended September 30, 2024, and $0.6 million for the full nine months ended September 30, 2024, compared to $0.5 million and $1.5 million in the same periods of 2023, respectively. The higher share-based compensation during 2023 was primarily related to new stock option grants issued during that period, the repricing of previously issued stock options during the first quarter of 2023, and related fluctuations in the Company’s stock price over such periods.

• On August 31, 2023, the Company’s functional currency changed to the USD from the CAD; as such, the Company recorded a derivative liability on the warrants outstanding with previously issued CAD exercises prices. This derivative liability is being revalued at each reporting period.

• During the first quarter of 2024, 376,801 warrants were re-priced from CAD to USD denominated exercise price which resulted in $3.9 million of the derivative liability being reclassified to equity. As of September 30, 2024, the Company revalued the derivative liability to $0.7 million and recorded a gain on revaluation of $0.3 million for the three months ended September 30, 2024, and related loss for the nine months ended September 30, 2024, of $140 thousand.

• The Company reported Grant Income and Grant Expense of $61.1 thousand and $0.3 million for the three and nine months ended September 30, 2024, respectively, compared to $32.8 thousand for the same periods of 2023, respectively.

• The third quarter of 2024 net loss was $1.9 million, or a net loss of $0.31 per share, and for the full nine months ended September 30, 2024, net loss was $9.0 million, or a net loss of $1.51 per share, compared to the third quarter of 2023 net loss of $3.3 million, or a net loss of $0.84 per share, and for the full nine months ended September 30, 2023, a net loss of $8.0 million, or a net loss of $2.23 per share.

• Cash and cash equivalents at September 30, 2024 were $3.7 million, excluding restricted cash.

• On November 5, 2024, the Company completed a reverse stock split on the ratio of one share issued for every previously issued and outstanding twenty-five shares. All current and comparative references to the number and price per share for common shares, preferred shares, options, warrants, ACI Canada legacy performance options and weighted average number of shares, loss per share, have been restated to give effect to this reverse stock split.

• Shares of common stock outstanding at September 30, 2024 were 6,034,216.

About Alpha Cognition Inc.

Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as AD and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.

ZUNVEYL is a novel patented oral Alzheimer’s disease therapy with a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine. As a new generation acetylcholinesterase inhibitor, it was developed to demonstrate a potentially improved GI side effect profile and has a CNS safety profile that includes no incidence of insomnia. While precise mechanism of action is not known, it is believed that ZUNVEYL works through two distinct pathways to enhance neurotransmitter activity and protect neuronal health, leading to improved cognitive and functional outcomes.

Separately, ZUNVEYL is also being developed in combination with memantine to treat moderate-to-severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. For more information about ZUNVEYL, please visit www.zunveyl.com or contact info@alphacognition.com and connect with us on Twitter and LinkedIn.

The Canadian Securities Exchange (the “CSE”) does not accept responsibility for the adequacy or accuracy of this release.

Forward-looking Statements

This news release includes forward-looking statements within the meaning of applicable United States and Canadian securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the Company’s planned commercial development of ZUNVEYL, the anticipated long-term efficacy and tolerability profile of ZUNVEYL, plans regarding the development of ZUNVEYL in combination with memantine to treat moderate-to-severe AD, and as an intranasal formulation for Cognitive Impairment with mTBI, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL , risks regarding the efficacy and tolerability of ZUNVEYL , risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL , risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL , risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1 registration statement as filed with the SEC on July 30, 2024 and available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

Basis of Presentation – The Company financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the rules of the Securities and Exchange Commission (the “SEC”).

Contacts

For further information:

Michael McFadden, CEO

Tel: 1-858-344-4375

info@alphacognition.com
https://www.alphacognition.com/

Tivic Reports Third Quarter 2024 Financial Results and Provides Business Update




Tivic Reports Third Quarter 2024 Financial Results and Provides Business Update

Pre-recorded Conference Call to Follow at 1:30 p.m. PDT/4:30 p.m EDT

FREMONT, Calif.–(BUSINESS WIRE)–Tivic Health^® Systems, Inc. (Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced third quarter and nine-months ended September, 30, 2024 financial results and discussed growth strategies based on its novel, patent-pending vagus nerve stimulation (VNS) science and device technology.

“This quarter we made significant progress on each of the three prongs of our strategy for delivering shareholder value,” stated Jennifer Ernst, CEO of Tivic Health. “The first prong is the aggressive steps we have taken to improve the economics of the ClearUP product line — our commercially available handheld, trigeminal nerve stimulation device for sinus and allergy conditions. This quarter, we completed the redesign of our supply chain, and, net of one-time costs, saw upwards of 70% gross margin in the months following the transition.

“The second leg, and most important element of our strategy, is our development of a non-invasive vagus nerve stimulation system that has the potential to catalyze Tivic’s long-term value. In a Phase 1 trial earlier this year, we demonstrated clinically meaningful changes in autonomic, cardiac and neurologic systems using a patent-pending approach to non-invasive VNS. This positions the company to enter significantly higher value markets. This quarter we began the clinical optimization of our system, working with industry experts at the Feinstein Institute of Bioelectronic Medicine.

“In parallel, we have also engaged a leading growth consulting firm to work closely with our clinical team on prioritizing these high value use cases based on the needs of patients, providers and payers. Already we have identified several multi-billion dollar market opportunities for the program. We expect to reach a significant inflection point in the business in the next twelve months as we build out our VNS medical device program,” concluded Ernst.

Third Quarter and Subsequent Weeks Business and Operational Updates

In the third quarter 2024 and subsequent weeks, the company announced the following:

• Started and completed enrollment of patients in a Phase 1a optimization study designed to identify device parameters that optimally influence autonomic nervous system (ANS) function.
• Partnered with Fletcher Spaght (FSI), a leading healthcare growth strategy firm, to accelerate development of Tivic’s commercial strategy for non-invasive cervical VNS (ncVNS).
• Appointed Lisa Wolf as interim CFO, effective October 1, replacing Kimberly Bambach, who will continue to provide special project work and strategic consulting to the company.
• Completed supply chain redesign to drive increased profitability of ClearUP™ product line.

Financial Performance

• Revenue (net of returns) for the three and nine months ended September 30, 2024 was $126,000 and $600,000, respectively, a decrease of $219,000, or 27%, compared with the first nine months of 2023 primarily due to a 36% decrease in unit sales, offset by a 13% increase in the per unit average sales price.
• Cost of sales for the three and nine months ended September 30, 2024 was $82,000 and $359,000, respectively, a decrease of $178,000, or 34%, compared with the first nine months of 2023.
• Gross profit in the three and nine months ended September 30, 2024 was $44,000 and $241,000, respectively, compared with $108,000 and $282,000 in 2023.
• Total operating expenses year to date 2024 were reduced by $1.9 million compared to the nine months ended September 30, 2023. For three months ended September 30, 2024 operating expenses totaled $1.5 million, down from $1.9 million a year ago. For the nine months ended September 30, 2024 total operating expenses were $4.4 million, down from $6.3 million in 2023.
• During the three months ended September 30, 2024 company incurred a net loss of $1.4 million, compared with $1.8 million for the same period in 2023. Net loss for the first nine months of 2024 was $4.2 million, a decrease of $1.8 million compared to the same period in 2023.
• At September 30, 2024 cash and cash equivalents totaled $2.2 million, compared with $3.4 million at December 31, 2023. During October and November 2024, the Company raised net proceeds of $775,000 through sales of common stock pursuant to an Equity Distribution Agreement.

Conference Call and Webcast Information

Management will host a webcast/conference call today, November 14, at 1:30 PM PST / 4:30 PM EST to discuss the company’s third quarter 2024 financial results and provide a business update.

Conference Call Details:

Toll Free: 877-545-0523

International: 973-528-0016

Access Code: 507355

Webcast Link

https://www.webcaster4.com/Webcast/Page/2865/51524

An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at https://tivichealth.com/investor/.

About Tivic Health

Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s technology platforms leverage stimulation of the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP™ is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP™ is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com @TivicHealth

Forward-Looking Statements

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the future development of ncVNS treatment; Tivic Health’s ability to commercialize products arising out of the ncVNS treatment and Tivic Health’s plans to seek regulatory approval for such clinical products; Tivic Health’s continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility, including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; Tivic Health’s ability to raise additional capital on favorable terms, or at all, when needed; Tivic Health’s ability to maintain its Nasdaq listing; and unexpected costs, charges or expenses that reduce Tivic Health’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health’s actual results to differ from those contained in the forward-looking statements, see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

Contacts

Media Contact:
Morgan Luke

Morgan.Luke@tivichealth.com

Investor Contact:
Hanover International, Inc.

ir@tivichealth.com

Celltrion Announces the Acquisition of iQone Healthcare Switzerland, Further Building Its Expertise and Foothold in Europe




Celltrion Announces the Acquisition of iQone Healthcare Switzerland, Further Building Its Expertise and Foothold in Europe

• Celltrion announces acquisition of iQone Healthcare Switzerland, accelerating direct commercialization of its biosimilars in the European region
• The acquisition strengthens Celltrion’s presence in Europe, driving growth and expanding access to its innovative biosimilar treatments

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270), a global biopharmaceutical leader, announced its acquisition of iQone Healthcare Switzerland, a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland.

The acquisition, expected to close by Q4, 2024, represents a significant milestone in Celltrion’s European expansion strategy. Upon completion, iQone Healthcare Switzerland will become a wholly owned subsidiary of Celltrion Healthcare Hungary Kft. The deal will also provide Celltrion access to in-licensing opportunities, further strengthening its pipeline of innovative therapies.

Taehun Ha, Head of Europe and Vice President of Celltrion, Inc., emphasized the acquisition’s importance, stating, “This move represents a strategic shift in our growth strategy. While we have successfully built direct sales networks, we are now leveraging acquisitions to accelerate our European expansion. With a distribution network spanning more than 20 regions, we are well-positioned to compete in the increasingly competitive biosimilar market.”

He added, “As a fully integrated company, Celltrion manages every stage of the value chain—from R&D and manufacturing to sales, marketing and distribution. This integration enables us to continue and expand our stable and growing supply of high-quality biosimilars, including in Switzerland, where we aim to further solidify our market presence and portfolio. It also underscores our commitment to leadership through local operational excellence and continuous innovation.”

Laurent Massuyeau, founder and Executive Chairman of iQone Healthcare Switzerland, expressed his optimism, stating, “Our successful decade-long partnership with Celltrion has laid very strong foundations for this integration. By combining Celltrion’s portfolio expertise with our established commercial operation, this acquisition will drive growth and enhance access to essential biosimilar and innovative medicines in Switzerland.

True to our values and with the support of the program “iQone for You”, an outstanding set of services directed to healthcare professionals and specially crafted for the Swiss market, we will continue to serve our customers with agility and efficiency and bring new therapeutic opportunities quickly to Switzerland.”

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima^®, Truxima^® and Herzuma^®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma^® and Yuflyma^®, FDA approval for Zymfentra^®, and EC approval for Remsima^® SC, Omlyclo^®, SteQeyma^®. To learn more, please visit www.celltrion.com/en-us.

About iQone Healthcare Switzerland

iQone Healthcare, a Swiss-based specialty pharmaceutical company, is dedicated to the commercialization of biosimilars and innovative treatments for rare diseases. Its mission is to ensure that therapeutic advancements are accessible to Swiss patients in a timely manner, providing the care they need when they need it.

Through its long-standing collaborations with several global pharmaceutical developers and manufacturers, iQone Healthcare provides a continually expanding selection of leading biosimilars and innovative products to healthcare professionals and institutions in Switzerland.

iQone Healthcare has maintained a decade-long partnership with Celltrion as exclusive distribution partner for Switzerland, successfully marketing Celltrion product range, including Remsima®, Veblocema®, Truxima®, Herzuma®, Vegzelma®, and Yuflyma®.

For more information, visit www.iqone-healthcare.com

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries’ management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion Inc. and its subsidiaries believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Contacts

Celltrion Global PR Team

globalpr@celltrion.com

InnoCare Announces First Subject Dosed in the Phase III Registrational Trial of TYK2 Inhibitor ICP-332 for the Treatment of Atopic Dermatitis in China




InnoCare Announces First Subject Dosed in the Phase III Registrational Trial of TYK2 Inhibitor ICP-332 for the Treatment of Atopic Dermatitis in China

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, today announced that the first subject has been dosed in the Phase III registrational trial of the Company’s novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-332 for the treatment of atopic dermatitis (AD) in China.

ICP-332 is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including atopic dermatitis (AD), vitiligo, inflammatory bowel disease, etc., with broad market prospects. As a non-receptor tyrosine kinase, TYK2 is a member of the JAK kinase family, which is an important kinase on the JAK-STAT signaling pathway and plays an important role in the pathogenesis of inflammatory diseases.

Currently, no TYK2 inhibitors have obtained marketing approval for the treatment of AD anywhere in the world. ICP-332 achieved multiple efficacy endpoints in the China Phase II study for the treatment of patients with moderate-to-severe atopic dermatitis (AD), demonstrating an outstanding efficacy and safety profile. ICP-332 showed a better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison).

According to the Global Burden of Disease Study by WHO, the number of patients with atopic dermatitis is as high as 230 million, making it the skin disease with the highest disease burden among nonfatal diseases. In China, the number of patients with atopic dermatitis continues to increase year by year.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, “Autoimmune diseases can affect almost every organ in the body and can occur at any age. InnoCare is dedicated to advancing the global frontier in autoimmune therapy by focusing on B-cell and T-cell pathways. We have developed a robust pipeline of differentiated therapeutics for autoimmune disease with significant market potential worldwide, including orelabrutinib (BTK inhibitor), ICP-332 (TYK2-JH1 inhibitor), ICP-488 (TYK2-JH2 inhibitor) and the novel small molecule inhibitor of IL-17. We are committed to accelerating clinical development and look forward to our innovative drugs benefiting patients with autoimmune diseases.”

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.

Contacts

Media
Chunhua Lu

86-10-66609879

chunhua.lu@innocarepharma.com

Investors
86-10-66609999

ir@innocarepharma.com

Zai Lab Announces Pricing of Public Offering of American Depositary Shares




Zai Lab Announces Pricing of Public Offering of American Depositary Shares

SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 7,843,137 American depositary shares (“ADSs”), each representing ten ordinary shares of the Company, at a price of US$25.50 per ADS.

The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $200 million. Subject to customary closing conditions, the underwriters expect to deliver the ADSs against payment to the purchasers on or about November 18, 2024, on a “T+2” basis. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 1,176,470 ADSs at the public offering price, less underwriting discounts and commissions. Zai Lab intends to use the net proceeds from this offering for general corporate purposes.

Goldman Sachs (Asia) L.L.C., Jefferies and Leerink Partners are acting as joint book-running managers for the ADS offering.

The ADSs are offered pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission (“SEC”) on April 19, 2024 (the “Form S-3ASR”). The offering is being made only by means of a prospectus supplement and an accompanying base prospectus included in the Form S-3ASR. A final prospectus supplement relating to the offering will be filed with the SEC. The registration statement on Form S-3ASR and the prospectus supplement are available at the SEC’s website at: http://www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may be obtained from: (i) Goldman Sachs & Co. LLC, c/o Prospectus Department, 200 West Street, New York, NY, facsimile: 212-902-9316 or by emailing Prospectus-ny@ny.email.gs.com, (ii) Jefferies LLC, c/o Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com, and (iii) Leerink Partners LLC, c/o Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs 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 Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. Zai Lab is focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. The Company’s goal is to leverage its competencies and resources to positively impact human health in China and worldwide.

Zai Lab Forward-Looking Statements

This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements relating to our ability to successfully complete the offering on the timeline and with the terms and conditions satisfactory to us, the anticipated use of proceeds therefrom, the possible adverse impact on the market price of our ADSs and ordinary shares due to the dilutive effect of the securities to be sold in the offering, capital market risks, and the impact of general economic or industry conditions. All statements, other than statements of historical fact, included in this press release are forward-looking statements and can be identified by containing words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of U.S. federal securities laws. Forward-looking statements are not guarantees or assurances of future performance. There can be no assurance that we will be able to complete the public offering on the anticipated terms, or at all. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission, including the registration statement and prospectus supplement related to the offering, which are available at www.sec.gov.. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

ZAI LAB CONTACTS:
Investor Relations:
Christine Chiou / Lina Zhang

+1 (917) 886-6929 / +86 136 8257 6943

christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com

Media:
Shaun Maccoun / Xiaoyu Chen

+1 (857) 270-8854 / +86 185 0015 5011

shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com