ETON Eton Pharmaceuticals Inc.

3.57
-0.01  0%
Previous Close 3.58
Open 3.66
52 Week Low 3.01
52 Week High 10.3
Market Cap $87,844,045
Shares 24,606,175
Float 19,718,577
Enterprise Value $68,368,180
Volume 229,717
Av. Daily Volume 253,648
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Drug Stage Catalyst Date
Zonisamide oral suspension - (ET-104)
Epilepsy
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Drug Pipeline

Drug Stage Notes
EPRONTIA (topiramate) - Oral Solution
Seizures/migraine
Approved
Approved
FDA Approval November 8, 2021.
REZIPRES (ephedrine hydrochloride injection)
Injectable hospital product
Approved
Approved
FDA approval announced June 15, 2021.
Cysteine Inj (DS-300)
Nutritional deficiencies
CRL
CRL
CRL received October 2020 (announced November 12, 2020). Expects to respond in December 2020.
Biorphen (ET-202)
Injectable hospital product
Approved
Approved
FDA Approval announced October 22, 2019.
ET-105 (Lamotrigine for Oral Suspension)
Lennox-Gastaut syndrome, epilepsy
CRL
CRL
CRL issued March 17, 2020. Additional trial to be completed in the coming months.
Novothyrox (EM-100)
Allergic conjunctivitis
Approved
Approved
FDA approval announced September 25, 2020.
Dehydrated alcohol injection (DS-100)
Methanol poisoning
CRL
CRL
CRL announced May 28, 2021.
Alkindi Sprinkle
Pediatric adrenal insufficiency (AI)
Approved
Approved
FDA approval announced September 29, 2020.

Latest News

    • Product is now available exclusively through Anovo specialty pharmacy
    • Product is stable at room temperature while Carbaglu® requires refrigeration
    • Eton Cares patient support program will offer $0 co-pays to commercial insurance patients

    DEER PARK, Ill., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases and ANI Pharmaceuticals, Inc (NASDAQ:ANIP), a bio-pharmaceutical company serving patients in need through the development and manufacturing of high-quality generic and branded medicines, today announced the commercial launch of Carglumic Acid tablets.

    The product will be marketed by Eton Pharmaceuticals and is…

    • Product is now available exclusively through Anovo specialty pharmacy
    • Product is stable at room temperature while Carbaglu® requires refrigeration
    • Eton Cares patient support program will offer $0 co-pays to commercial insurance patients

    DEER PARK, Ill., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases and ANI Pharmaceuticals, Inc (NASDAQ:ANIP), a bio-pharmaceutical company serving patients in need through the development and manufacturing of high-quality generic and branded medicines, today announced the commercial launch of Carglumic Acid tablets.

    The product will be marketed by Eton Pharmaceuticals and is the first and only FDA-approved generic version of Carbaglu®. It was approved by the FDA for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. The product is AB-rated and is bioequivalent and therapeutically equivalent to Carbaglu®, which allows pharmacies to substitute it in place of Carbaglu® prescriptions. The product application is owned by Novitium Pharmaceuticals, a subsidiary of ANI Pharmaceuticals.

    "We are excited to offer patients a convenient Carglumic Acid product that does not require refrigeration and to provide it at a lower price than the existing Carbaglu®. We believe the adoption of our product will result in significant financial savings to the U.S. healthcare system and to many patients through lower co-pay and co-insurance costs," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

    The product application was granted Competitive Generic Therapy (CGT) designation by the FDA, and as a result, the product is expected to receive 180 days of generic exclusivity. "This approval further strengthens ANI's focus on niche opportunities and maintains our leadership position in Competitive Generic Therapy approvals," said Nikhil Lalwani, CEO Of ANI Pharmaceuticals.

    Carglumic Acid tablets are available exclusively through Anovo, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. Anovo will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program will provide prescription fulfillment, insurance benefits investigation, educational support, aid qualified patients to obtain financial assistance along with other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for $0 co-pays for qualifying patients.

    Clinicians seeking to prescribe Carglumic Acid tablets can e-prescribe by selecting Anovo #5 or fax in a patient referral form. Additional product details can be found on the product website, www.carglumicacid.com.

    For questions regarding prescription fulfillment, please contact Anovo at 1-888-991-1330.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about Carglumic Acid?

    • Carglumic Acid tablets are for oral suspension and must be mixed in water before taking. Carglumic Acid should not be mixed in any food or liquid other than water.
    • Do not swallow Carglumic Acid tablets whole.
    • Do not crush Carglumic Acid tablets.
    • Take Carglumic Acid right before meals or feedings.

    What are the possible side effects of Carglumic Acid?

    • The most common side effects of Carglumic Acid include vomiting, abdominal pain, fever, tonsillitis, anemia, diarrhea, ear infection, infections, inflammation of the throat and nasal passages, decreased hemoglobin in the red blood cells, and headache.
    • This is not a complete list of all possible side effects. Tell your doctor if you have any side effect that bothers you or that does not go away.

    Please visit www.carglumicacid.com for more information.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call the FDA at 1-800-FDA-1088.

    Please see the Full Prescribing Information, including Instructions for Use, for Carglumic Acid.

    USE

    • Carglumic Acid is for pediatric and adult patients as supplemental therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
    • Carglumic Acid is for pediatric and adult patients as maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.

    Carbaglu® is a registered trademark of Recordati Rare Disease Inc.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE®, Carglumic Acid, Biorphen®, Alaway® Preservative Free, Rezipres®, and Eprontia™, and has four additional products that have been submitted to the FDA.



    About ANI Pharmaceuticals

    ANI Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. For more information, please visit www.anipharmaceuticals.com.

    Eton's Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates, the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing, and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    ANI's Forward-Looking Statements

    To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the development, manufacturing and commercialization of the product and any additional product launches from the Company's generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words and the use of future dates.

    Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

    More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission ("SEC"), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

    Eton Contact:

    David Krempa



    612-387-3740



    ANI Media Contact:

    Angela Salerno-Robin



    212-445-8219

     



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  1. LONDON, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV:DMT) (OTCQB:DMTTF) (the "Company" or "Small Pharma"), a neuropharmaceutical company focused on psychedelic-assisted therapies, announces that Mr. Paul Maier has been appointed as a non-executive independent director of the board of directors of the Company (the "Board"). He will hold office as an independent director until the next annual meeting of shareholders, or until his successor has been elected or appointed. Mr. Maier has also been appointed as a member of the Audit Committee and Corporate Governance and Nominating Committee and Chair of the Compensation Committee.

    Mr. Maier joins Small Pharma with over 30 years' experience in senior executive roles across the biopharmaceutical…

    LONDON, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV:DMT) (OTCQB:DMTTF) (the "Company" or "Small Pharma"), a neuropharmaceutical company focused on psychedelic-assisted therapies, announces that Mr. Paul Maier has been appointed as a non-executive independent director of the board of directors of the Company (the "Board"). He will hold office as an independent director until the next annual meeting of shareholders, or until his successor has been elected or appointed. Mr. Maier has also been appointed as a member of the Audit Committee and Corporate Governance and Nominating Committee and Chair of the Compensation Committee.

    Mr. Maier joins Small Pharma with over 30 years' experience in senior executive roles across the biopharmaceutical and biotech industry. He has a successful track record at U.S. publicly listed biotech companies, raising over US$1.5bn in equity and debt financing across his career, as well as extensive expertise in company and product acquisitions and IPOs. Mr. Maier has served as Chief Financial Officer at Sequenom, Inc. and Ligand Pharmaceuticals, Inc. He currently serves on the board of 4D pharma plc (NASDAQ:LBPS), Eton Pharmaceuticals, Inc. (NASDAQ:ETON), Biological Dynamics, and International Stem Cell Corporation (OTC:ISCO). He previously served on the board of other publicly listed companies, including Ritter Pharmaceuticals, Inc., Apricus Biosciences, Inc., and MabVax Therapeutics Holdings, Inc. Mr. Maier holds an MBA from the Harvard Graduate School of Business.

    Lyne Fortin, Chair of the Board of Small Pharma, said: "We are delighted to welcome someone of Paul's calibre to the Board of Small Pharma. His appointment adds important expertise and capabilities to the Board as he brings broad financial and leadership experience as well as a relevant network in the North American capital markets which will be invaluable as we look to grow the business. With our first product in clinical trials and a promising pipeline of candidates, a strong diversified Board is essential in guiding the business through this critical growth period."

    Mr. Maier added: "It is an honor to join the Small Pharma Board at this exciting juncture for the Company. I look forward to working with the dedicated Board and talented management team to build upon the work that has been done to date and continue to create long term value from this innovative therapy for all stakeholders involved in mental health."

    In connection with his appointment, the Board has granted Mr. Maier stock options (each, an "Option") to purchase up to an aggregate of 30,000 common shares in the capital of the Company (each, a "Common Share") pursuant to the Company's stock option plan. Each Option is exercisable for one Common Share at a price equal to CDN$0.435 per share, being the closing price of the Common Shares on November 17, 2021. The Options are exercisable for a period of ten years from the date of grant and are subject to certain vesting criteria.

    About Small Pharma

    Small Pharma is a neuropharmaceutical company specialized in IP led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into N,N-dimethyltryptamine ("DMT") assisted therapy in February 2021. This program includes a Phase I/IIa trial on its lead candidate alongside development of a robust pipeline of proprietary preclinical assets.

    About DMT

    DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world's first DMT clinical trial for MDD, in collaboration with Imperial College London.

    For further information contact: 

    Small Pharma Inc.

    Peter Rands

    Chief Executive Officer

    Email:

    Tel: +44 (0)2071 129118

    Media Relations Contact

    McKenna Miller

    KCSA Strategic Communications

    Email:

    Tel: +1 (949) 949-6585

    Investor Relations Contacts

    Eric Ribner

    LifeSci Advisors

    Email:

    Tim Regan/Adam Holdsworth

    KCSA Strategic Communications

    Email:

    Tel: +1 (347) 487-6788

    Cautionary Note

    Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The UK Medicines and Healthcare products Regulatory Agency ("MHRA") or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma's performance and operations.

    The TSX Venture Exchange (the "TSXV") has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.



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  2. DEER PARK, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the third quarter ended September 30, 2021.

    "Over the last month we have made tremendous advancements to our commercial portfolio. We gained two more FDA-approved products, EPRONTIA and carglumic acid, both of which should launch in the fourth quarter, and we are increasing ALKINDI SPRINKLE's commercial footprint more than ten-fold through an attractive co-promotion arrangement with Tolmar Pharmaceuticals. These events put us in an even stronger position to deliver significant revenue and reach sustained…

    DEER PARK, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the third quarter ended September 30, 2021.

    "Over the last month we have made tremendous advancements to our commercial portfolio. We gained two more FDA-approved products, EPRONTIA and carglumic acid, both of which should launch in the fourth quarter, and we are increasing ALKINDI SPRINKLE's commercial footprint more than ten-fold through an attractive co-promotion arrangement with Tolmar Pharmaceuticals. These events put us in an even stronger position to deliver significant revenue and reach sustained profitability in 2022," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

    Major Business Updates

    • Acquired marketing rights to FDA-approved carglumic acid tablets. Eton's product is the first and only generic alternative to Carbaglu® and is indicated for acute and chronic hyperammonemia due to N-acetylglutamine Synthase (NAGS) deficiency. Carbaglu® is widely believed to be one of the most expensive treatments in the world and Eton looks forward to offering a lower-cost alternative to patients and caregivers.



    • FDA Approval of EPRONTIA™ (topiramate) oral solution. Earlier this month, the U.S. Food and Drug Administration (FDA) approved EPRONTIA™, the first oral liquid formulation of topiramate. EPRONTIA™ is now Eton's sixth approved product. The product will be marketed by Azurity Pharmaceuticals and is expected to be available before the end of the year. The product's launch will trigger a $5 million milestone payment to Eton, and Eton will also receive a royalty on sales of the product and potential future commercial milestone payments.



    • Significantly expanded ALKINDI SPRINKLE®'s commercial footprint through a co-promotion partnership with Tolmar Pharmaceuticals. Tolmar's 62-person commercial sales force is expected to be fully trained and promoting ALKINDI SPRINKLE® in December. The transaction is expected to significantly accelerate product adoption and ALKINDI SPRINKLE® sales growth.

    ALKINDI SPRINKLE® Commercial Update

    In a separate press release issued this morning, Eton announced that it has entered into a co-promotion arrangement with Tolmar Pharmaceuticals for the promotion of ALKINDI SPRINKLE®.

    ALKINDI SPRINKLE® sales continued to grow month-over-month in the third quarter and in October. During the quarter, Eton held an advisory panel with key opinion leaders in the pediatric endocrinology community and product feedback continues to be overwhelmingly positive as doctors appreciate the critical importance of precisely dosing pediatric patients when treating adrenal insufficiency. Eton believes in-person meetings have proven to be effective at driving adoption, and as a result, is drastically increasing ALKINDI SPRINKLE®'s commercial footprint through the co-promotion arrangement.

    Portfolio Update

    Eton now has six FDA-approved products, three of which (carglumic acid, EPRONTIA®, and Rezipres®) are expected to launch in the fourth quarter of 2021. The company also has four additional products that have been submitted to the FDA and could be approved and launched in 2022.

    Biorphen® & Rezipres® Vial Conversions. Biorphen® and Rezipres® registration batches have successfully been manufactured in vials, and Eton will submit the supplement applications to the FDA as soon as the necessary stability data is available. Eton expects the vial format of both products to be approved and launched in 2022.

    Dehydrated Alcohol Injection. Eton recently held a meeting with the FDA to discuss the dehydrated alcohol product application's complete response letter and Eton's proposed responses. Based on the positive outcome of the meeting, Eton believes the FDA's requests are fully addressable, and the company expects to submit its response as an amendment in the coming months.

    Zonisamide Oral Suspension. Eton continues to believe the only item holding up FDA approval of the zonisamide oral suspension product application is the FDA inspection of the product's European manufacturer. The FDA has assigned the product application a new target action date of January 29, 2022, but the FDA has yet to conduct or schedule the onsite inspection. Eton will receive a $5 million milestone payment upon the approval and launch of zonisamide.

    Lamotrigine for Suspension. The product's human factor study was successfully completed during the quarter. Eton's partner intends to submit the results to the FDA later this month. The submission should allow for a potential approval of the product in the first half of 2022. Eton will receive a $5 million milestone payment upon the approval and launch of lamotrigine.

    Cysteine Hydrochloride Injection. Eton's paragraph IV litigation and FDA application review remain on going. Eton expects to receive tentative approval from the FDA in advance of the 30-month stay expiration in August 2022.

    Zeneo Hydrocortisone Autoinjector. Development activities are ongoing and the product remains on pace for an expected NDA submission in 2023.

    Financial Results

    Revenue: Eton reported revenue of $0.8 million for the third quarter of 2021. Eton reported no material revenue in the third quarter of 2020.

    General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2021 were $3.3 million compared to $3.4 million in the prior-year period. Decrease was largely due to elevated spending in the prior year period related to launch preparation activities for ALKINDI SPRINKLE®. The third quarter of 2021 included $0.9 million of non-cash expenses.

    Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were $2.7 million compared to $2.8 million in the prior-year period. R&D expenses in the third quarter of 2021 were elevated due to expenses related to the development of Biorphen® and Rezipres® vial container conversion. R&D expenses in the third quarter of 2020 included a one-time $1.5 million NDA filing fee.

    Net Income: Eton reported a net loss of $6.1 million for the third quarter of 2021, compared to a net loss of $6.5 million in the prior-year period. Eton reported diluted earnings per share (EPS) of ($0.24) in the third quarter of 2021, compared to ($0.31) in the prior year period.

    Cash Position: Cash and cash equivalents were $22.7 million as of September 30, 2021.

    Conference Call and Webcast Information:

    Eton Pharmaceuticals will host a conference call and webcast today at 4:30 p.m. ET (3:30 p.m. CT). To access the conference call, please dial 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 1875678. The webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at https://ir.etonpharma.com. The webcast will be archived and made available for replay on the company's website approximately two hours after the call and will be available for 30 days.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE®, carglumic acid, Biorphen®, Alaway® Preservative Free, Rezipres®, and Eprontia™, and has four additional products that have been submitted to the FDA.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates, the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Eton Pharmaceuticals, Inc.

    Condensed Statements of Operations

    (In thousands, except per share amounts)

    (Unaudited)

                 
      For the three months ended  For the nine months ended 
      September 30,  September 30,  September 30,  September 30, 
      2021  2020  2021  2020 
    Revenues:            
    Licensing revenue $  $  $14,000  $ 
    Product sales and royalties  775   (161)  1,739   (42)
    Total net revenues  775   (161  15,739   (42
                     
    Cost of sales:                
    Licensing revenue        1,500    
    Product sales and royalties  617   (144)  843   (14)
    Total cost of sales  617   (144  2,343   (14
                     
    Gross profit (loss)  158   (17)  13,396   (28)
                     
    Operating expenses:                
    Research and development  2,678   2,826   5,554   10,703 
    General and administrative  3,327   3,429   10,651   8,960 
    Total operating expenses  6,005   6,255   16,205   19,663 
                     
    Loss from operations  (5,847)  (6,272)  (2,809  (19,691)
                     
    Other (expense) income:                
    Interest and other (expense) income, net  (247)  (232)  (731)  (592)
    Gain on PPP loan forgiven        365    
    Gain on equipment sale        181    
                     
    Loss before income tax expense  (6,094)  (6,504)  (2,994  (20,283)
                     
    Income tax expense            
                     
    Net loss $(6,094) $(6,504) $(2,994 $(20,283)
    Net loss per share, basic and diluted $(0.24) $(0.31) $(0.12 $(1.01)
    Weighted average number of common shares outstanding, basic and diluted  25,276   21,052   25,181   20,070 
     
     

    Eton Pharmaceuticals, Inc.

    Condensed Balance Sheets

    (in thousands, except share and per share amounts)

      September 30, 2021  December 31, 2020 
       (Unaudited)     
    Assets        
    Current assets:        
    Cash and cash equivalents $22,709  $21,295 
    Accounts receivable, net  385   48 
    Inventories  334   1,242 
    Prepaid expenses and other current assets  2,435   2,116 
    Total current assets  25,863   24,701 
             
    Property and equipment, net  134   811 
    Intangible assets, net  463   575 
    Operating lease right-of-use assets, net  123   192 
    Other long-term assets, net  23   40 
    Total assets $26,606  $26,319 
             
    Liabilities and stockholders' equity        
    Current liabilities:        
    Accounts payable $3,273  $2,344 
    Current portion of long-term debt  1,092    
    PPP loan, current portion     280 
    Accrued liabilities  995   1,170 
    Total current liabilities  5,360   3,794 
             
    Long-term debt, net of discount and including accrued fees  5,550   6,532 
    Long-term portion of PPP and EIDL loans     231 
    Operating lease liabilities, net of current portion  36   99 
             
    Total liabilities  10,946   10,656 
             
    Commitments and contingencies         
             
    Stockholders' equity        
    Common stock, $0.001 par value; 50,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 24,606,175 and 24,312,808 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively  25   24 
    Additional paid-in capital  110,787   107,797 
    Accumulated deficit  (95,152)  (92,158)
    Total stockholders' equity  15,660   15,663 
             
    Total liabilities and stockholders' equity $26,606  $26,319 
     
     

    Eton Pharmaceuticals, Inc.

    Condensed Statements of Cash Flows

    (In thousands)

    (Unaudited)

      Nine months ended

    September 30, 2021
      Nine months ended

    September 30, 2020
     
    Cash flows from operating activities        
    Net loss $(2,994) $(20,283)
             
    Adjustments to reconcile net loss to net cash provided by (used in) operating activities:        
    Stock-based compensation  2,518   1,803 
    Common stock issued for product candidate licensing rights     1,264 
    Depreciation and amortization  325   490 
    Debt discount amortization  110   85 
    Gain on forgiveness of debt  (365)   
    Gain on sale of equipment  (181)   
    Changes in operating assets and liabilities:        
    Accounts receivable  (337)  473 
    Inventories  908   (1,319)
    Prepaid expenses and other assets  (283)  1,305 
    Accounts payable  929   1,633 
    Accrued liabilities  (234)  (615)
    Net cash provided by (used in) operating activities  396   (15,164)
             
    Cash provided by (used in) investing activities        
    Proceeds from sale of equipment  700    
    Purchases of property and equipment  (5)  (6)
    Net cash provided by (used in) financing activities  695   (6)
             
    Cash flows from financing activities        
    Proceeds from sales of common stock, net of offering costs     7,756 
    Proceeds from issuance of long-term debt, net of issuance costs     1,965 
    EIDL loan payoff  (150)   
    Proceeds from PPP and EIDL loans     511 
    Proceeds from employee stock purchase plan and stock option exercises  473   204 
    Net cash provided by financing activities  323   10,436 
             
    Change in cash and cash equivalents  1,414   (4,734)
    Cash and cash equivalents at beginning of period  21,295   12,066 
    Cash and cash equivalents at end of period $22,709  $7,332 
             
    Supplemental disclosures of cash flow information        
    Cash paid for interest $603  $545 
    Cash paid for income taxes $  $ 
             
    Supplemental disclosure of non-cash financing activity        
    Relative fair value of warrants to purchase common stock issued in connection with debt $  $94 






    Investor Contact:

    David Krempa



    612-387-3740

            

     



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  3. DEER PARK, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON) today announced that it has entered into a multi-year agreement with Tolmar Pharmaceuticals, Inc. to co-promote ALKINDI SPRINKLE®. Eton will leverage Tolmar's 62-person sales force and their existing relationships in the pediatric endocrinology specialty. Tolmar currently promotes FENSOLVI® (leuprolide acetate) for injectable suspension, indicated for pediatric patients 2 years of age and older with Central Precocious Puberty (CPP).

    "It's clear that physicians see the need for ALKINDI SPRINKLE's accurate dosing when treating adrenal insufficiency, however, we have found that changing the decades old prescribing habits of pediatric endocrinologists is…

    DEER PARK, Ill., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON) today announced that it has entered into a multi-year agreement with Tolmar Pharmaceuticals, Inc. to co-promote ALKINDI SPRINKLE®. Eton will leverage Tolmar's 62-person sales force and their existing relationships in the pediatric endocrinology specialty. Tolmar currently promotes FENSOLVI® (leuprolide acetate) for injectable suspension, indicated for pediatric patients 2 years of age and older with Central Precocious Puberty (CPP).

    "It's clear that physicians see the need for ALKINDI SPRINKLE's accurate dosing when treating adrenal insufficiency, however, we have found that changing the decades old prescribing habits of pediatric endocrinologists is often requiring multiple face-to-face interactions. With this partnership, our reach will be increasing more than 10-fold and we will drastically increase the number of face-to-face interactions. We believe this will translate to significantly faster adoption of ALKINDI SPRINKLE and accelerate the time to reach peak conversion," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "We are confident Tolmar is the right partner for ALKINDI SPRINKLE. Their FENSOLVI® launch results speak for themselves and highlight their team's ability to drive treatment change in pediatric endocrinology," added Brynjelsen.

    "We are excited to co-promote ALKINDI SPRINKLE," said Tolmar CEO Anil D'Souza. "This agreement will further enhance Tolmar's commitment to the pediatric endocrinology space. It allows Tolmar to continue providing therapies with optimal delivery mechanisms that improve patient and caregiver experience."

    Tolmar's pediatric endocrinology sales force currently promotes the specialty drug FENSOLVI® for CPP, a rare disease that impacts roughly one in 5,000-10,000 children in the United States. FENSOLVI® was launched in May 2020 and has already reached more than 1,500 patients.

    Under terms of the agreement, Tolmar's sales force will promote ALKINDI SPRINKLE® to their pediatric endocrinology targets alongside FENSOLVI®. Tolmar will receive a royalty on net sales growth above ALKINDI SPRINKLE®'s current baseline sales.   Eton's sales force will continue to promote the product and Eton will maintain responsibility for all non-sales force related commercial activities.

    The companies expect Tolmar's sales force to start promoting ALKINDI SPRINKLE® in December. In tandem with the co-promotion launch, Eton plans to introduce an expanded digital marketing campaign targeted at raising awareness among patients and caregivers.

    About ALKINDI SPRINKLE®

    ALKINDI SPRINKLE® (hydrocortisone) oral granules is FDA-approved as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age. ALKINDI SPRINKLE® is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children. The approval of ALKINDI SPRINKLE® was supported by six clinical studies, including the first and only interventional open-label Phase III study of oral hydrocortisone for Pediatric AI in neonates to children under eight years of age. Prior to the approval of ALKINDI SPRINKLE®, oral hydrocortisone was only FDA-approved in tablet formulations of 5mg and stronger. Many pediatric patients require significantly lower doses and the flexibility of precise titration. ALKINDI SPRINKLE® is available in 0.5mg, 1mg, 2mg, and 5mg strengths, allowing clinicians greater flexibility to individualize dosing based on each patient's needs in accordance with the instructions for dosage and administration. Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.

    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE®, carglumic acid, Biorphen®, Alaway® Preservative Free, Rezipres®, and Eprontia™, and has four additional products that have been submitted to the FDA.

    About Tolmar

    Tolmar is a fully integrated pharmaceutical company focused on the innovative development, approval, manufacturing, and commercialization of specialty pharmaceuticals. "Tolmar" refers to Tolmar Holding, Inc. and its wholly owned operating subsidiaries, Tolmar Inc., Tolmar Therapeutics, Inc., and Tolmar Pharmaceuticals, Inc. Tolmar global headquarters, product development and manufacturing facilities are based in northern Colorado, while Tolmar Pharmaceuticals' U.S. commercial business is based in Buffalo Grove, Illinois. For more information about the company, please visit www.tolmar.com.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates, the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Important Safety Information for ALKINDI SPRINKLE® (hydrocortisone) Oral Granules

    Adrenal Crisis: Undertreatment or sudden discontinuation of therapy may lead to symptoms of adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stressor events, such as infections or surgery. Monitor patients closely when switching from other forms of hydrocortisone to ALKINDI SPRINKLE®. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations.

    Infections: Excessive doses may increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. Monitor patients for signs and symptoms of infections. Treat all infections seriously, and initiate stress dosing of steroids early.

    Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE® to achieve desired clinical response and monitor the patient's growth.

    Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing's syndrome. Monitor patients for signs and symptoms of Cushing's syndrome every 6 months; pediatric patients under one year of age may require more frequent monitoring.

    Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption, which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of ALKINDI SPRINKLE® to achieve desired clinical response.

    Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop.

    Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist.

    Gastrointestinal Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; and active or latent peptic ulcer.

    Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions.

    Adverse Reactions

    Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.

    INDICATION

    ALKINDI SPRINKLE® is a corticosteroid indicated for replacement therapy in pediatric patients with adrenocortical insufficiency.

    Please see full Prescribing Information for more information.

    Important Safety Information for FENSOLVI® (leuprolide acetate) for injectable suspension

    FENSOLVI® (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.

    FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.

    During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.

    Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.

    Convulsions have been observed in patients treated with GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.

    The most common adverse events seen with FENSOLVI were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush.

    Please see Full Prescribing Information for additional important safety information.

    Company Contacts:

    Eton Pharmaceuticals, Inc.

    David Krempa



    612-387-3740

    Tolmar Pharmaceuticals, Inc.

    Julie Ferguson



    312-385-0098



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  4. DEER PARK, Ill. and WOBURN, Mass., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON) and Azurity Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EPRONTIA™ (topiramate) oral solution, 25mg/mL.

    EPRONTIA™ has been approved as a monotherapy for treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and as a preventive treatment of migraine in patients 12 years of age and older.

    "This is a transformative day for patients living…

    DEER PARK, Ill. and WOBURN, Mass., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (NASDAQ:ETON) and Azurity Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EPRONTIA™ (topiramate) oral solution, 25mg/mL.

    EPRONTIA™ has been approved as a monotherapy for treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and as a preventive treatment of migraine in patients 12 years of age and older.

    "This is a transformative day for patients living with epileptic seizures and migraines and their families and caregivers," said Amit Patel, Chairman and CEO of Azurity Pharmaceuticals. "We take great pride in developing therapies that give healthcare practitioners the ability to treat patients whose needs are not served by available medicines."

    EPRONTIA™ is the first oral liquid formulation of topiramate to be approved by the FDA. Azurity will be responsible for commercializing the product and anticipates product availability before year end. Eton will receive a $5 million milestone payment upon EPRONTIA's commercial launch, a royalty on net sales, and potential commercial milestones.



    "We are proud to see the approval of EPRONTIA™ and we believe it will address a critical unmet need for patients requiring adherence, compliance and precision dosing with a liquid formulation. We look forward to continuing to work with Azurity to achieve additional approvals from our CNS portfolio partnership," added Sean Brynjelsen, CEO of Eton Pharmaceuticals.



    About Eton Pharmaceuticals

    Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from six FDA-approved products, including ALKINDI® SPRINKLE, carglumic acid, Biorphen®, Alaway® Preservative Free, Rezipres®, and Eprontia™, and has four additional products that have been submitted to the FDA.

    About Azurity Pharmaceuticals Inc.

    Azurity Pharmaceuticals is a privately held specialty pharmaceutical company that focuses on innovative products that meet the needs of patients with underserved conditions. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

    Company Contacts:

    Eton Pharmaceuticals, Inc.

    David Krempa



    612-387-3740



    Azurity Pharmaceuticals, Inc.

    Se-Se Yennes



    781-935-8141 Ext. 126   



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