Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that the U.S. District Court for the Western District of Washington issued an order providing for preliminary approval of a proposed settlement of the claims asserted nominally on behalf of Athira against the individual defendants named in the previously disclosed stockholder derivative actions entitled Bushansky v. Kawas et al. No. 2:22-cv-497 and Houlihan v. Kawas et al ., No. 2:22-cv-620, pending before the court. The proposed settlement calls for Athira to adopt certain corporate governance reforms and pay lead plaintiffs' attorney's fees, litigation expenses, and lead plaintiff service awards.
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Hydralyte Partners With Roolife To Expand Global Distribution Footprint In China
Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte North America” or “the Company”) is pleased to announce it has appointed e- commerce company RooLife Group Ltd (“RooLife”) (ASX:RLG) to exclusively market, sell and distribute its leading range of Hydralyte products in China.
HIGHLIGHTS
- HPC confirms the appointment of ASX-listed RooLife Group (ASX:RLG) to market, sell and distribute the Hydralyte range of electrolyte-rich tablets, liquids and powders in China.
- The appointment aligns strategically with the Company’s aim to expand the global addressable market for Hydralyte North America products through targeted partnerships.
- Under the terms of the agreement, RLG will manage digital marketing and e-commerce store operations with exclusive distribution rights for Hydralyte products across online and physical stores.
- Distribution partnership aims to leverage the high profile of Australian health & wellness products to drive increased brand awareness in China through RLG’s extensive network of China-based distribution partnerships across e-commerce and physical stores.
The distribution agreement with RooLife aligns with HPC’s strategy to expand the global addressable market for its leading product range through a targeted partnership approach that seeks to leverage the respective strengths of both parties.
The Company’s decision to partner with RooLife provides Hydralyte North America with a unique access point to the Chinese consumer market through RLG’s existing distribution channels, which have been established over a long period of time in accordance with rigorous compliance standards for imported goods.
With its established presence in China, RLG expects to provide Hydralyte North America with direct and immediate access to an expanded group of sales channels and the capacity to scale up further through additional distribution partnerships as they occur.
The broader distribution networks provided through RooLife will comprise both e-commerce and bricks & mortar retailers, complementing HPC’s existing agreement with Alibaba subsidiary Tmall.
The distribution process for Hydralyte products into China also has the potential to be accelerated due to the fact that Hydralyte North America products are classified as a food product rather than a supplement, which allows for a simpler regulatory pathway to gain import approval for the Chinese market.
Strategically, the agreement with RooLife has been assessed by the Hydralyte North America Board and management team as a distribution opportunity that could provide the Company with potentially material upside with minimal downside risk from an operations and capital management perspective.
Under the terms of the agreement, RLG will provide digital marketing and social media management services along with operations management for e-commerce. RLG will receive a margin on all Hydralyte products sold in accordance with the terms of the agreement.
The agreement with RooLife is for a 2 year and 5-month term (Term) with the ability for the Term to be extended by 1 year by mutual written agreement by the parties. The remaining terms of the agreement are considered commercially sensitive.
The economic materiality of the agreement with RLG is unknown due to the uncertainty in sales outcomes and no minimum sales order requirements. However, the Company expects that entering into a partnership with RLG may have a material impact on the Company’s business development prospects and global distribution opportunities.
Management commentary:
Chief Executive Officer Mr Oliver Baker said: “RLG’s well-established online sales channels and access to growing physical store network is the perfect platform to enter the large China market.
Their highly capable sales & marketing offering and understanding of how to sell and promote a product to Chinese consumers presents us with a very unique opportunity to establish the Hydralyte brand here.”
RooLife Group CEO, Bryan Carr added: “We are excited to add such a high-profile and proven brand as Hydralyte to our healthy, functional food and beverage portfolio in China where we continue to grow out our online and physical store channels, servicing the high consumer demand for quality international products with China’s large, emerging middle class. We look forward to working with Hydralyte’s very dynamic team, extending their global sales footprint considerably by leveraging the growing awareness of health and wellness generally in China and the established trust and awareness for Australian-founded wellness brands, making Hydralyte a great match for RLG and our capabilities in China.”
About RooLife Group: RooLife Group is a cross-border distribution platform that matches leading international brands and products with the key trends in Chinese consumer demand. The Company has built an extensive network of distribution channels across ecommerce and traditional retail in the Chinese market and complements its service offering with fully integrated digital market and customer acquisition services. RooLife’s online eCommerce marketplaces assist businesses to sell directly to Chinese consumers with integrated payment solutions via the WeChat and Alipay platforms. RLG serves a broad range of international clients from Australia and other jurisdictions including New Zealand, Europe, the UK and the United States.
Click here for the full ASX Release
This article includes content from The Hydration Pharmaceuticals Company Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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Hydralyte International
Overview
Hydralyte International (ASX:HPC) is an ASX-listed rapid hydration solutions business focused on the large North American and European markets.
With an established supply chain in both Canada and the United States, the company recently surpassed US$10.4 million in 12-month trailing revenue with a gross margin of a staggering 58 percent during Q3 FY23. The company delivered strong revenue of US$2.6 million in Q3 2023, combined with an ongoing reduction in net cash used in operating activities.
Hydralyte rapid rehydration product was also the number one SKU in the hydration category on Amazon Prime Day in Canada, where it's the number two hydration brand overall with a 21 percent market share. Starting on Prime Day, Hydralyte delivered ~US$140,000 in gross sales over 48 hours – which has underpinned a strong ecommerce sales pipeline in the recent months.
It's also worth noting that all this revenue growth – alongside a partnership with Shay Mitchell – occurred with an ongoing reduction in marketing expenditure; marketing costs as a percentage of sales were down a third straight quarter in Q3 FY2 to 30 percent (a record low since IPO). This is due in part to the company's solid leadership team, featuring professionals with decades of expertise in health and wellness, as well as heavy brand investments which have been made throughout 2022.
In Australia, New Zealand and parts of Southeast Asia, Prestige Consumer Healthcare Incorporated (NYSE:PBH) holds the exclusive sales and distribution rights to Hydralyte products. PBH is an American over-the-counter healthcare marketing and distribution company, dating back more than 100 years.
Meanwhile, Hydralyte International’s sales in the UK are exceeding expectations, with the company’s products now appearing both on Amazon UK and store shelves in Whole Foods and Chemist Warehouse stores, providing another potentially lucrative revenue channel.
Hydralyte International's robust supply chain, sales trajectory, manufacturing approach and product strategy are far from the only reasons it shows such promise as an investment. Current market trends also significantly favor the company's core value proposition. Valued at US$1.42 billion in 2017, the global electrolyte hydration drinks market is expected to reach US$1.82 billion by 2025 as consumers turn away from high-sugar, low-electrolyte drinks and towards more clinical hydration products.
Roughly 75 percent of Americans are dehydrated at any given time. The reasons are many and varied, ranging from travel and exercise to alcohol and illness. Its symptoms are something many of us have simply learned to live with – irritability, brain fog, dizziness, increased thirst, dry mouth and fatigue, to name just a few.
Hydralyte fits the bill perfectly for these consumers. Founded with the goal of making a difference through better hydration, Hydralyte is able to treat dehydration more effectively than the majority of sports drinks on the market. Thanks to its proprietary formula – which uses a precise ratio of water, electrolytes and glucose based on the World Health Organization's recommended formula for rapid rehydration.
Hydralyte is available in three forms: ready-to-drink, tablet and dissolvable powder stick. All three are widely accepted in the medical community. Hydralyte is also frequently used by professional athletes as an alternative to sports drinks.
In short, thanks to its market position, strong leadership and science-based formula, Hydralyte represents the perfect opportunity for investors to enter the lifestyle sports market.
Company Highlights
- Hydralyte International is a rapid hydration drink business with a focus on North America and established supply chains in both the United States and Canada.
- The company's 2023 financials are incredibly promising:
- Trailing 12 months revenue of US$10.4 million in Q3 FY23
- 58 percent gross margin in Q3 2023
- Cash burn reduction of 47 percent on PCP to US$1.46 million in Q3 FY22, with initiatives in place expected to reduce this further
- US$140,000 in gross sales from Amazon Prime Day in July.
- Although Hydralyte recently reduced its marketing expenditure, it still experienced strong revenue growth throughout the first three quarters of 2023, driven by ongoing eCommerce sales, an established brick-and-mortar footprint, new SKU additions and a partnership with leading entrepreneur and actress, Shay Mitchell.
- The United Kingdom represents an international expansion opportunity for Hydralyte, with products being sold on Amazon UK and appearing on store shelves in Whole Foods and Chemist Warehouse.
- Agreement with specialist e-commerce company RooLife Group Limited (ASX: RLG) to exclusively market, sell and distribute Hydralyte products in China
- Appointed leading health and wellness products broker LeBeau Excel as its new sales broker, giving Hydralyte the ability to significantly expand its footprint in the Canadian market.
- In addition to a solid manufacturing base and supply chain, Hydralyte is supported by leaders with decades of experience in health and wellness.
- Hydralyte products are widely accepted in both the medical and athletic communities. As a result, the company is extremely well-positioned to leverage the fast-growing electrolyte hydration drinks market.
Core Product Offering
Hydralyte Rapid Rehydration
Hydralyte is based on the World Health Organization's recommended formula for rapid rehydration. Made from all-natural ingredients, it contains the precise ratio of glucose and electrolytes necessary to rehydrate. Its innovative formula contains up to 75 percent less sugar and four times more electrolytes than the majority of sports drinks.
Highlights:
- Multiple SKUs: Available as a tablet, powder and premade drink, Hydralyte comes in a range of different flavors and formulations, including:
- Liver Support: 7 key electrolytes, six antioxidants, ginger, turmeric, milk thistle and prickly pear.
- Apple Cider Vinegar: 4 key electrolytes, apple cider vinegar, vitamins B12, B6 and C.
- Collagen: 5 key electrolytes, Verisol collagen, vitamin C and zinc.
- Immunity with Elderberry: 7 key electrolytes, vitamin C, magnesium and zinc.
- SPORT: Launched in 2022, these tablets are designed with the needs of athletes in mind.
- Promising Partnerships: In December 2022, Hydralyte launched a brand partnership with Shay Mitchell, a Canadian actress and entrepreneur with over 36 million Instagram followers. The two parties launched a co-branded product through HPC eCommerce channels and Amazon USA. A Canadian launch is currently pending.
- Strategic Agreements: Hydralyte has engaged specialist e-commerce company RooLife Group Limited to exclusively market, sell and distribute Hydralyte products in China. It has also appointed LeBeau Excel as its new sales broker to significantly expand Hydralyte’s footprint in the Canadian market.
Management Team
Oliver Baker – CEO
Oliver Baker is the former general manager of Swisse Wellness USA, a vitamin, supplement and skincare brand that in 2015 sold for US$1.7 billion. During his tenure at Swisse, Baker employed a dedicated eCommerce strategy that enabled a successful US launch. He also led the integration team in Guangzhou, migrating ~US$73 million in sales and building up a local Chinese team.
Prior to his position at Swisse, Baker worked in multiple global and national sales and marketing roles with a focus on sports sponsorships.
George Livery – Chairman
George Livery has close to thirty years of experience in senior roles both domestically and internationally. Most recently, he served as director of strategy & corporate at Swisse Wellness, where he originally began as commercial director. Livery has also served as executive chairman for multiple major organizations, including Bod Australia.
Adem Karafili – Non-executive Director
A registered CPA and business professional with more than 15 years of experience, Adem Karafili has operated in leadership positions across a range of different sectors and industries. Most recently, he spent several years at Swisse Wellness, beginning as chief financial officer before becoming chief operating officer and managing director. While there, he helped to establish Swisse as a leading global health and wellness brand.
Karafili holds a Bachelor of Business Administration in accounting and is chairman of multiple health and wellness corporations.
Chris Kavanaugh – CFO
Chris Kavanaugh has over 20 years of experience running finance and operations for growing startups from inception to US$30M+ in revenue. He has worked with Hydralyte for over five years, starting as a controller before being promoted to chief financial officer in 2021. Prior to his position at Hydralyte, he served as a director of finance for companies including Fullbridge, Education Incorporated and OneVision Resources.
Kavanaugh has a Bachelor in Accounting and Management with a double major in information systems from Indiana University of Pennsylvania.
Margaret Hardin – Non-executive Director
Over the course of her career, Margaret Hardin has served as CEO and CFO for numerous major product companies in the United States including Baby Super Brands, ERGObaby Carrier Incorporated and Munchkin. With over two decades of experience, Hardin has a well-established reputation for driving growth through innovation, strategic acquisitions and geographic expansion. She holds a BBA from New Mexico State and an MBA from the Booth Graduate School of Business at the University of Chicago.
Brandon Fishman – US Advisor
Brandon Fishman is the Founder and CEO of VitaCup, a vitamin-infused functional coffee and tea brand that surpassed US$20 million in sales in five years. Over the course of his career, Fishman has worked with multiple Fortune 500 brands in a range of different capacities, in the process building up considerable entrepreneurial wisdom. Other companies founded by Fishman include NewCondosOnline and Internet Marketing Incorporated.
Fishman holds a Bachelor of Business Administration and Finance from Emory University and a Master in Real Estate & Business from the University of San Diego.
Athira Pharma Announces Proposed Settlement of Stockholder Derivative Action
The order set a final approval hearing for Thursday, July 18, 2024, at 10:30 am. As required by the order, the following materials have been posted to the Investor Relations section of Athira's website ( http://investors.athira.com/ ): the Zoom meeting information for the final approval hearing, the Stipulation of Settlement, a Summary Notice of Proposed Settlement of Stockholder Derivative Action, and a Notice of Proposed Settlement of Derivative Actions, Final Approval Hearing, and Right to Appear.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to alter the course of neurological diseases by advancing its pipeline of therapeutic candidates that modulate the neurotrophic HGF system, including fosgonimeton, which is being evaluated for the potential treatment of mild-to-moderate Alzheimer's disease in the Phase 2/3 LIFT-AD trial that is expected to report topline data in the second half of 2024. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on X, (formerly known as Twitter ) , and Instagram.
Investor & Media Contact:
Julie Rathbun
Athira Pharma
Julie.rathbun@athira.com
206-769-9219
News Provided by GlobeNewswire via QuoteMedia
Praxis Precision Medicines to Participate in Upcoming Investor Conferences
Praxis Precision Medicines Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that management will be participating in three upcoming conferences.
- Praxis management will participate in a fireside chat at the H.C. Wainwright 2 nd Annual BioConnect Investor Conference, taking place in New York, NY at the NASDAQ Stock Exchange on May 20, 2024 at 10:00am EDT. A live webcast of the fireside chat will be available through this link and will also be available through the "Upcoming & Recent Events" page of the Investors + Media section of the company's website www.praxismedicines.com . A replay of the webcast will be available on Praxis' website for 90 days following the event.
- Praxis management will also participate in the Mizuho Securities USA Neuroscience Summit, taking place in Boston, MA on May 21, 2024.
- Praxis management will also be participating in a fireside chat at the Jefferies Global Healthcare Conference, taking place in New York, NY on June 6, 2024 at 11:30am EDT. A live webcast of the fireside chat will be available through this link and will also be available through the "Upcoming & Recent Events" page of the Investors + Media section of the company's website www.praxismedicines.com . A replay of the webcast will be available on Praxis' website for 90 days following the event.
About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on Facebook , LinkedIn and Twitter/X .
Investor Contact: Praxis Precision Medicines investors@praxismedicines.com 857-702-9452 Media Contact: Dan Ferry Life Science Advisors Daniel@lifesciadvisors.com 617-430-7576
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Annexon Reports Inducement Grants to New Employees Under Nasdaq Listing Rule 5635
Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for people living with devastating inflammatory-related diseases, today announced that it has granted inducement to two new non-executive employees under the terms of the 2022 Employment Inducement Award Plan. The equity awards were approved on May 11, 2024, in accordance with Nasdaq Listing Rule 5635(c)(4).
In the aggregate, the new non-executive employees received options to purchase 52,590 shares of Annexon common stock. The options carry a ten-year term and an exercise price per share equal to $4.50, which was the closing price of Annexon's common stock on May 15, 2024, the date of grant, and vest over 4 years, with 25% of the shares underlying the options vesting on the first anniversary of the grant date and an additional 1/48th of the shares vesting monthly thereafter, subject to continued service through the applicable vesting dates.
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon's novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington's disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit annexonbio.com.
Investor Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
News Provided by GlobeNewswire via QuoteMedia
Nuvectis Pharma, Inc. to Present at the H.C. Wainwright BioConnect Investor Conference
Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that Ron Bentsur, Chairman and Chief Executive Officer, will present at the H.C. Wainwright 2 nd BioConnect Investor Conference at the NASDAQ world headquarters in New York City.
Event | H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ |
Date | May 20th, 2024 |
Time | 12:00 PM Eastern Time |
Link | Fireside Chat [ Link ] |
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action in that it inhibits both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.
Company Contact
Ron Bentsur
Chairman, Chief Executive Officer and President
201-614-3151
rbentsur@nuvectis.com
Media Relations Contact
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
News Provided by GlobeNewswire via QuoteMedia
HCW Biologics Reports First Quarter 2024 Financial Results and Business Highlights
HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2024.
Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, "We reached an important clinical development milestone in the first quarter of 2024. Enrollment was completed in two ongoing clinical trials to evaluate HCW9218 in solid tumors. We are encouraged by the number of patients with evidence of stable disease, even though it is difficult of generalize from Phase 1 and Phase 1b results. We are following our strategy to participate in fully randomized Phase 2 clinical trials in difficult-to-treat cancer indications, working with leading clinical sites. Using this strategy, we believe we can cost effectively evaluate HCW9218 as a single arm in a larger study. We intend to advance our cancer studies in ovarian and pancreatic cancer, while seeking to opportunistically participate in other cancer trials that have strong sponsors with financial support."
He added, "With the recommended Phase 2 dose established in our early studies, we plan to expand into age-related indications in skin diseases and conditions associated with senescence. These studies will be designed as investigative studies, and we anticipate that it will be quicker to see human data read outs from this type of indication than would be possible in a cancer study. We are interested to see the aesthetic effects with the deep wrinkles and senile lentigo, perhaps as secondary endpoints."
Business Highlights
- The Company raised $6.1 million to date in 2024, from private placement of common stock and issuance of senior secured notes.
- Management financing plans are to raise a bridge financing through the issuance of up to an aggregate of $10.0 million of Secured Notes, of which $3.6 million have been issued to date in 2024. If we succeed, we expect the bridge financing will enable the Company to continue with its clinical development plans, until such time as it can complete planned business development transactions such as license for non-core assets and capital raising transactions.
- The Phase 1 clinical trial to evaluate HCW9218 in solid tumors and the Phase 1b clinical trial to evaluate HCW9218 in pancreatic cancer were completed in February 2024. The studies met the primary objective to determine a recommended Phase 2 dose ("RP2D").
- In February 2024, we entered into an agreement with University of Pittsburgh Medical Center ("UPMC") to conduct an Investigator-sponsored Phase 2 clinical trial to evaluate HCW9218 in patients with metastatic advanced stage ovarian cancer in combination with neoadjuvant chemotherapy. Patient enrollment is expected to begin in the second half of 2024.
- We are preparing an IND application to evaluate our IL-2 based product candidate designed to activate and expand T reg cells, HCW9302, in an autoimmune disease, which we plan to submit in the third quarter of 2024.
First Quarter 2024 Financial Results
- Revenues: Revenues for the first quarters ended March 31, 2023 and 2024 were $41,883 and $1.1 million, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company's licensee, Wugen. The licensed molecules are one of the inputs for manufacturing Wugen's products. In 2023, revenues were negatively impacted by changes in Wugen's clinical development program. In addition, Wugen suffered delays in ramping up its manufacturing process which also limited purchases of molecules licensed by the Company in 2023.
- Research and development (R&D) expenses: R&D expenses for the first quarters ended March 31, 2023 and 2024 were $2.3 million and $2.1 million, respectively. The $132,529 decrease, or 6%, resulted primarily from a decline in preclinical expenses, partially offset by an increase in manufacturing and material costs. Manufacturing costs increased in three-month period ended March 31, 2024 because the Company replenished supply of a high-expressing cell line of HCW9101. Preclinical expenses declined primarily due to a change in the preclinical activities in March 31, 2024 versus the comparable period one year earlier. In the three-month period ended March 31, 2023, preclinical costs were incurred for setup costs for toxicology studies and other IND-enabling studies to prepare an IND application to obtain permission from the FDA to evaluate HCW9302 in an autoimmune indication. In the three-month period ended March 31, 2024, costs were incurred for supplemental research studies required for this IND application. Clinical trial expenses were incurred in the three-month periods ended March 31, 2023 and 2024 related to two ongoing clinical studies to evaluate HCW9218 in chemo-refractory / chemo-resistant solid tumors, including a Phase 1 study in patients with various types of solid tumors and a Phase 1b study in pancreatic cancer.
- General and administrative (G&A) expenses: G&A expenses for the first quarters ended March 31, 2023 and 2024 were $3.1 million and $6.0 million, respectively, a $2.9 million increase, or 94%. The increase was primarily attributable to an increase in legal expenses related to the Altor/NantCell matter. See further discussion of the Altor/NantCell arbitration in "Financial Guidance."
- Net loss: Net loss for the three-month periods ended March 31, 2023 and 2024 was $5.1 million and $7.5 million, respectively.
Financial Guidance
As of March 31, 2024, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the condensed financial statements, without additional funding or financial support. After giving consideration to the elements of the Company's financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis.
Management has made some reductions in costs, but in order to continue the clinical development for the Company's lead product candidates, the Company must maintain a core group of scientists. The Company continues to pursue a plan to obtain bridge financing through the issuance of up to $10.0 million in Secured Notes, $3.6 million of which have been issued to date in 2024. The Company anticipates that this bridge financing, if fully subscribed, will allow the Company to reach such time as it can execute plans for business development transactions such as licenses for non-core assets and capital-raising transactions, although there can be no assurance of this outcome for many reasons, including the uncertainties regarding the Company's ongoing arbitration proceedings with Altor/NantCell, as described below. In addition to the bridge financing in the form of the issuance of additional Secured Notes, other potential near-term financing plans may include cooperative agreements for clinical trials and third-party collaboration funding. If the Company is not successful in raising additional capital, management has the intent and ability to revise its business plan and reduce costs. If such revisions are insufficient, the Company may have to curtail or cease operations.
On December 23, 2022, Claimants Altor and NantCell ("Altor/NantCell") filed a complaint against the Company in the U.S. District Court for the Southern District of Florida (the "Court"), alleging claims of misappropriation of trade secrets, tortious interference with contractual relations, inducement of breach of fiduciary duty, and specific performance/injunction for assignment of patents and patent applications, among other claims. That same day, Altor/NantCell also initiated an arbitration against the Company's CEO and Founder, Dr. Wong, based on nearly identical allegations and alleging breach of contract, breach of fiduciary duty, and fraudulent concealment, among other claims. The Company moved to compel arbitration and the parties ultimately stipulated to the same. On April 27, 2023, in connection with the Altor/NantCell matter, the Court approved the parties' stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell's proceeding against the Company is now proceeding in arbitration before JAMS and is consolidated with the arbitration Altor/NantCell initiated against Dr. Wong. The arbitration hearing scheduled to begin on May 20, 2024. In addition, on March 26, 2024, Altor/NantCell filed a complaint (the "Complaint") against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong in connection with the arbitration discussed above. Prior to the filing of the Complaint, Altor/NantCell had previously sought advancement from the Company and the Company agreed to advance 50% of Dr. Wong's legal fees going forward from December 2023. On January 8, 2024, Altor/NantCell reserved their right to pursue contribution against the Company for 50% of the amount Altor/NantCell sent for advancement of expenses for Dr. Wong. In the Complaint, Altor/NantCell seek 50% of the fees they have already advanced to Dr. Wong, a declaration that the Company has an obligation to contribute 50% of the advancement of Dr. Wong's expenses including 50% of Dr. Wong's expenses incurred in connection with the arbitration through final resolution of the matter, and costs and fees in bringing this action. Although adverse decisions (or settlements) may occur in arbitration, it is not possible to reasonably estimate the possible loss or range of loss, if any, associated therewith at this time. As such, no accrual for these matters has been recorded within the Company's financial statements. The Company incurred significant legal expenses in connection with this matter in the period ended March 31, 2024, and expects to continue to incur material costs and expenses through the third quarter of 2024.
About HCW Biologics:
HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, autoimmune diseases, as well as other conditions such as long-haul COVID-19. The Company has combined a deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBI TM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics' two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Company completed the initial stages of two clinical trials to evaluate HCW9218 in cancer indications. The Masonic Cancer Center, University of Minnesota, was the sponsor of a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is the sponsor of a Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The University of Pittsburgh Medical Center has agreed to include HCW9218 in combination with neoadjuvant chemotherapy in a fully randomized trial. The Company is preparing an IND application for its lead molecule for its regulatory T cell expansion program, HCW9302, expected to be submitted in the first half of 2024.
Forward Looking Statements:
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words and include, without limitation, statements regarding potential of HCW9218 to be a first in class immunotherapeutic cancer treatment. initiation of Phase 2 clinical studies in cancer indications; potential to join other studies so HCW9218 can be assessed in more cancer indications; timing of initiation of studies for age-related diseases; the Company's ability to continue as a going concern; the Company's cash runway; the Company's expectations regarding future purchases of licensed molecules by Wugen; the Company's future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and timing and outcome of the Altor/NantCell arbitration and the Company's liability related thereto. Forward-looking statements are based on the Company'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. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled "Risk Factors" in the annual report on Form 10-K/A filed with the United States Securities and Exchange Commission (the "SEC") on May 15, 2024, and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Company Contact:
Rebecca Byam
CFO
HCW Biologics Inc.
rebeccabyam@hcwbiologics.com
HCW Biologics Inc. Unaudited Statements of Operations | ||||||||
Three Months Ended March 31, | ||||||||
2023 | 2024 | |||||||
Revenues: | ||||||||
Revenues | $ | 41,883 | $ | 1,126,712 | ||||
Cost of revenues | (29,350 | ) | (511,965 | ) | ||||
Net revenues | 12,533 | 614,747 | ||||||
Operating expenses: | ||||||||
Research and development | 2,255,813 | 2,123,284 | ||||||
General and administrative | 3,117,290 | 5,985,126 | ||||||
Total operating expenses | 5,373,103 | 8,108,410 | ||||||
Loss from operations | (5,360,570 | ) | (7,493,663 | ) | ||||
Interest expense | (93,438 | ) | — | |||||
Other (expense) income, net | 383,322 | 25,602 | ||||||
Net loss | $ | (5,070,686 | ) | $ | (7,468,061 | ) | ||
Net loss per share, basic and diluted | $ | (0.14 | ) | $ | (0.20 | ) | ||
Weighted average shares outstanding, basic and diluted | 35,883,779 | 37,223,588 |
HCW Biologics Inc. Condensed Balance Sheets | ||||||||
December 31, | March 31, | |||||||
2023 | 2024 | |||||||
Unaudited | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 3,595,101 | $ | 4,084,076 | ||||
Accounts receivable, net | 1,535,757 | 903,884 | ||||||
Secured note receivable | — | 250,000 | ||||||
Prepaid expenses | 1,042,413 | 783,423 | ||||||
Other current assets | 230,916 | 187,267 | ||||||
Total current assets | 6,404,187 | 6,208,650 | ||||||
Investments | 1,599,751 | 1,599,751 | ||||||
Property, plant and equipment, net | 20,453,184 | 22,590,779 | ||||||
Other assets | 56,538 | 28,476 | ||||||
Total assets | $ | 28,513,660 | $ | 30,427,656 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Liabilities | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 6,167,223 | $ | 10,493,416 | ||||
Accrued liabilities and other current liabilities | 2,580,402 | 2,919,190 | ||||||
Total current liabilities | 8,747,625 | 13,412,606 | ||||||
Debt, net | 6,304,318 | 8,274,449 | ||||||
Total liabilities | 15,051,943 | 21,687,055 | ||||||
Commitments and contingencies (Note 8) | ||||||||
Stockholders' equity: | ||||||||
Common stock: | ||||||||
Common, $0.0001 par value; 250,000,000 shares authorized and 36,025,104 shares issued at December 31, 2023; 250,000,000 shares authorized and 37,823,394 shares issued at March 31, 2024 | 3,603 | 3,782 | ||||||
Additional paid-in capital | 83,990,437 | 86,737,203 | ||||||
Accumulated deficit | (70,532,323 | ) | (78,000,384 | ) | ||||
Total stockholders' equity | 13,461,717 | 8,740,601 | ||||||
Total liabilities and stockholders' equity | $ | 28,513,660 | $ | 30,427,656 |
News Provided by GlobeNewswire via QuoteMedia
Athira Pharma Reports First Quarter 2024 Financial Results and Pipeline and Business Updates
Topline data from Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer's disease expected in second half of 2024
Submitted Investigational New Drug application to U.S. Food and Drug Administration for ATH-1105 for the treatment of amyotrophic lateral sclerosis; On track to dose subjects in a first-in-human study in second quarter of 2024
Strong balance sheet to support innovative pipeline through key clinical inflection points
Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the quarter ended March 31, 2024, and provided recent pipeline and business updates.
"We are on the cusp of a potentially transformative milestone as we are fast approaching the expected topline data readout from our Phase 2/3 LIFT-AD clinical trial of fosgonimeton in Alzheimer's disease (AD) in the second half of this year," said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. "The totality of clinical and nonclinical data to date support our confidence in the LIFT-AD trial and underscore the potential of our differentiated approach in targeting the neurotrophic HGF system to induce neuroprotective effects across a number of neurodegenerative diseases."
"We were delighted to welcome Javier San Martin, M.D. as our new Chief Medical Officer. His insight and expertise will be invaluable as we move toward the LIFT-AD data readout and the potential opportunity to deliver fosgonimeton as a new treatment option for AD patients in need of better therapies. In parallel, we continue to progress ATH-1105 in amyotrophic lateral sclerosis (ALS) and expect to initiate a first-in-human study of this oral small molecule drug candidate in the coming months," added Dr. Litton.
Clinical Development & Pipeline Programs
Athira's drug development pipeline includes potential first-in-class (fosgonimeton) and next-generation (ATH-1105 and ATH-1020) small molecule drug candidates designed to promote the neurotrophic hepatocyte growth factor (HGF) system, which activates neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system. Athira's drug candidates have distinct properties, which the Company believes may be applicable to a broad range of neurodegenerative diseases.
Fosgonimeton (ATH-1017) – A potentially first-in-class, once daily, subcutaneously administered drug candidate initially targeted for the potential treatment of Alzheimer's disease.
LIFT-AD Phase 2/3 clinical trial of fosgonimeton in mild-to-moderate Alzheimer's disease ( NCT04488419 )
- Athira expects to report topline data from LIFT-AD in the second half of 2024.
- In January 2024, Athira announced the completion of enrollment of the LIFT-AD study.
- The LIFT-AD study is investigating the effects of fosgonimeton 40 mg compared with placebo in mild-to-moderate AD patients who are not receiving background therapy. The primary endpoint is the Global Statistical Test (GST), combining the results from the co-key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23), which Athira believes is a comprehensive measure of overall disease burden. Other secondary and exploratory endpoints include changes in plasma biomarkers of neurodegeneration, protein pathology, and neuroinflammation.
Open Label Extension (OLEX) fosgonimeton trial ( NCT04886063 )
- Eligible participants who complete the Company's LIFT-AD or ACT-AD clinical trials and elect to participate in the ongoing OLEX are able to receive up to 48 months of open-label treatment.
- Greater than 85% of participants who completed either study have elected to enroll in OLEX to date.
- Currently, more than 65 patients are continuing fosgonimeton treatment beyond 18 months, which is unexpected in a progressive mild-to-moderate Alzheimer's disease population.
- Athira believes the OLEX will complement its long-term safety database and provide insights into fosgonimeton's long-term effects for potentially over four years of investigational treatment.
SHAPE Phase 2 clinical trial of fosgonimeton in Parkinson's disease dementia and dementia with Lewy bodies ( NCT04831281 )
- In December 2023, Athira announced encouraging findings from the exploratory SHAPE Phase 2 clinical trial of fosgonimeton for the potential treatment of Parkinson's disease dementia and dementia with Lewy bodies.
- Treatment with fosgonimeton 40 mg (n=5) compared to placebo (n=7) showed directional improvements in certain cognitive, functional and biomarker measurements, including ADAS-Cog13, MMSE, and COWAT over the 6-month double-blind treatment period.
- The primary endpoint of the trial, a composite score of the change in Event-Related-Potential (ERP) P300 latency and cognitive assessment (ADAS-Cog13), was not met by protocoled analysis compared with placebo.
- Fosgonimeton was generally well tolerated, with a favorable safety profile. There were no treatment-related serious adverse events observed in the study. The most common adverse event in the treatment groups was injection site reactions.
ATH-1105 – A next-generation, orally administered, small molecule drug candidate in development for the potential treatment of ALS.
- Athira submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for the evaluation of ATH-1105 as a potential treatment for ALS.
- Athira expects to initiate a first-in-human study of ATH-1105 in the second quarter of 2024.
- ATH-1105's potential is supported by a growing body of preclinical evidence demonstrating statistically significant improvements on nerve and motor function, biomarkers of inflammation and neurodegeneration, and survival in various models of ALS.
- These data have been presented at a variety of key scientific and medical meetings including the American Association of Neurology (AAN), the Alzheimer's Association International Congress (AAIC), the Northeast Amyotrophic Lateral Sclerosis Consortium ® (NEALS), and the Motor Neurone Disease Association (MNDA).
Corporate
- In April 2024, the Company announced the appointment of Javier San Martin, M.D., as Chief Medical Officer. Dr. San Martin is an experienced clinical development executive with a strong track record of advancing therapeutics from early development to approval and through commercialization. He joins Athira with more than 25 years of drug development experience, most recently as Chief Medical Officer of Arrowhead Pharmaceuticals.
Recent Presentations and Publications
- In April 2024, Athira presented a poster at the American Academy of Neurology (AAN) 2024 Annual Meeting, which highlighted preclinical data supporting the continued development of its small molecule candidates targeting the neurotrophic HGF system. The presentation was titled: "Targeting Neurotrophic HGF Signaling for the Treatment of Neurodegenerative Disorders."
- In April 2024, Athira published preclinical data supporting the therapeutic potential of fosgonimeton in Alzheimer's disease in the peer-reviewed journal, Neurotherapeutics . The original research article is titled: "Fosgonimeton attenuates amyloid-beta toxicity in preclinical models of Alzheimer's disease."
- The findings described several mechanisms by which fosgonimeton may disrupt the neurodegenerative cascade of Alzheimer's disease downstream of Aβ toxicity, including reduction of mitochondrial oxidative stress and excitotoxicity, improvement of autophagic pathway function, and attenuation of tau hyperphosphorylation.
- In March 2024, Athira presented new clinical and preclinical data further highlighting the therapeutic potential of fosgonimeton at the AD/PD™ 2024 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders.
- Results from the exploratory SHAPE Phase 2 clinical trial in Parkinson's disease dementia and dementia with Lewy bodies indicated a favorable safety and tolerability profile for fosgonimeton in trial participants. In addition, changes in ADAS-Cog13 observed in the fosgonimeton 40 mg dose arm were suggestive of a pro-cognitive effect, which was assessed for fosgonimeton for the first time in these disease states.
- In Alzheimer's preclinical disease models, results showed the neuroprotective effects of fosgonimeton against glutamate toxicity in vitro are driven, in part, by activation of pro-survival signaling pathways that may help to counteract neurodegenerative hallmarks of disease such as tau pathology and mitochondrial dysfunction.
- In Parkinson's preclinical disease models, results highlighted the ability of fosgonimeton to mitigate pathological alterations associated with α-synuclein toxicity in vitro and in vivo.
- In an aged mouse preclinical model of Parkinson's disease that included α-synuclein pathology and GBA1 inhibition, fosgonimeton improved motor function, promoted dopaminergic neuron survival, reduced α-synuclein aggregation, and protected against microglial activation.
- In February 2024, Athira published research highlighting the neuroprotective and anti-inflammatory effects of ATH-1105 in preclinical models of ALS in the peer-reviewed journal, Frontiers in Neuroscience . The original research article is titled: "ATH-1105, a small-molecule positive modulator of the neurotrophic HGF system, is neuroprotective, preserves neuromotor function, and extends survival in preclinical models of ALS."
- All presentations and publications can be accessed on the Athira website at Medical Affairs – Athira Pharma .
Financial Results
- Cash Position . Cash, cash equivalents and investments were $122.1 million as of March 31, 2024, compared to $147.4 million as of December 31, 2023. Net cash used in operations was $25.8 million for the quarter ended March 31, 2024, compared to $26.2 million for the quarter ended March 31, 2023.
- Research and Development (R&D) Expenses . R&D expenses were $21.2 million for the quarter ended March 31, 2024, compared to $21.3 million for the quarter ended March 31, 2023. The decrease was driven primarily by decreases in ATH-1020 program costs and personnel costs, partially offset by an increase in other indirect costs. Fosgonimeton program costs for the quarter ended March 31, 2024, were flat compared to the quarter ended March 31, 2023, as decreases in manufacturing and contract research organization costs were offset by increases in program consulting expenses and clinical site visit costs.
- General and Administrative (G&A) Expenses . G&A expenses were $6.5 million for the quarter ended March 31, 2024, compared to $8.5 million for the quarter ended March 31, 2023 . The decrease was driven by decreases in legal costs, business development expenses, professional services expenses, personnel costs, and other general corporate expenses.
- Net Loss . Net loss was $26.3 million, or $0.69 per share, for the quarter ended March 31, 2024, compared to a net loss of $27.8 million, or $0.73 per share, for the quarter ended March 31, 2023.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to alter the course of neurological diseases by advancing its pipeline of drug candidates that modulate the neurotrophic HGF system. For more information, visit www.athira.com . You can also follow Athira on Facebook , LinkedIn , X (formerly known as Twitter) and Instagram .
Forward-Looking Statements
This communication contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: Athira's drug candidates as potential treatments for Alzheimer's disease, Parkinson's disease, Parkinson's disease dementia, dementia with Lewy bodies, amyotrophic lateral sclerosis, and other neurodegenerative diseases; future development plans; the anticipated reporting of data; the potential learnings from preclinical studies and other nonclinical data, the ACT-AD and SHAPE trials, and LIFT-AD unblinded interim efficacy and futility analysis and their ability to inform and improve future clinical development plans; expectations regarding the potential efficacy and commercial potential of Athira's drug candidates; and Athira's ability to advance its drug candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "on track," "would," "expect," "plan," "believe," "intend," "pursue," "continue," "suggest," "potential," and similar expressions. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the data from preclinical and clinical trials may not support the safety, efficacy and tolerability of Athira's drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; Athira may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that have been or may in the future be instituted against Athira, its directors and officers; possible negative interactions of Athira's drug candidates with other treatments; Athira's assumptions regarding its financial condition and the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets; the impact of competition; the impact of expanded drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks detailed in Athira's filings with the Securities and Exchange Commission from time to time. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.
Investor & Media Contact:
Julie Rathbun
Athira Pharma
Julie.rathbun@athira.com
206-769-9219
Athira Pharma, Inc. Condensed Consolidated Balance Sheets (Amounts in thousands) | ||||||||
March 31, | December 31, | |||||||
2024 | 2023 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Cash and cash equivalents | $ | 77,821 | $ | 90,584 | ||||
Short-term investments | 44,267 | 56,835 | ||||||
Other short-term assets | 6,548 | 7,310 | ||||||
Other long-term assets | 4,822 | 5,516 | ||||||
Total assets | $ | 133,458 | $ | 160,245 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities | $ | 25,598 | $ | 28,840 | ||||
Long-term liabilities | 1,118 | 1,217 | ||||||
Total liabilities | 26,716 | 30,057 | ||||||
Stockholders' equity | 106,742 | 130,188 | ||||||
Total liabilities and stockholders' equity | $ | 133,458 | $ | 160,245 | ||||
Athira Pharma, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands, except share and per share amounts) (Unaudited) | ||||||||
Three Months Ended March 31, | ||||||||
2024 | 2023 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 21,236 | $ | 21,293 | ||||
General and administrative | 6,451 | 8,477 | ||||||
Total operating expenses | 27,687 | 29,770 | ||||||
Loss from operations | (27,687 | ) | (29,770 | ) | ||||
Grant income | — | 157 | ||||||
Other income, net | 1,350 | 1,793 | ||||||
Net loss | $ | (26,337 | ) | $ | (27,820 | ) | ||
Unrealized gain on available-for-sale securities | 212 | 927 | ||||||
Comprehensive loss attributable to common stockholders | $ | (26,125 | ) | $ | (26,893 | ) | ||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.69 | ) | $ | (0.73 | ) | ||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 38,321,573 | 37,923,402 |
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