ALNA Allena Pharmaceuticals Inc.

1.37
0  0%
Previous Close 1.37
Open 1.37
52 Week Low 0.525
52 Week High 6.3
Market Cap $51,996,173
Shares 37,953,411
Float 31,148,264
Enterprise Value $34,049,927
Volume 730,290
Av. Daily Volume 1,576,960
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Upcoming Catalysts

Drug Stage Catalyst Date
ALLN-346
Hyperuricemia
Phase 1
Phase 1
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Reloxaliase ALLN-177 (URIROX-2)
Enteric Hyperoxaluria
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Reloxaliase ALLN-177 (URIROX-1)
Enteric Hyperoxaluria
Phase 3
Phase 3
Phase 3 trial met primary endpoint, key secondary endpoint missed - November 7, 2019.
Reloxaliase ALLN-177 (Study 206)
Primary hyperoxaluria
Phase 2
Phase 2
Phase 2 presentation at ASN November 8, 2019.

Latest News

  1. NEWTON, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that the first subject has been dosed in a Phase 1 clinical trial of ALLN-346. ALLN-346 is an investigational, orally administered, novel urate-degrading enzyme that has been designed for activity and stability in the gastrointestinal (GI) tract, and is intended for the treatment of hyperuricemia in patients with gout and advanced chronic kidney disease (CKD).

    Hyperuricemia, or elevated levels of uric acid in the blood, is due to overproduction…

    NEWTON, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that the first subject has been dosed in a Phase 1 clinical trial of ALLN-346. ALLN-346 is an investigational, orally administered, novel urate-degrading enzyme that has been designed for activity and stability in the gastrointestinal (GI) tract, and is intended for the treatment of hyperuricemia in patients with gout and advanced chronic kidney disease (CKD).

    Hyperuricemia, or elevated levels of uric acid in the blood, is due to overproduction and/or insufficient excretion of uric acid and is a significant predisposing condition for gout. Increased uric acid excretion in the urine and hyperuricemia are also associated with kidney stone formation and kidney damage. CKD patients with hyperuricemia and gout are often not optimally managed due to limitations of available therapies, including decreased tolerability, dose restrictions, drug-drug interactions, and contraindications. According to a published study, there are approximately 375,000 patients in the United States with hyperuricemia and CKD on urate lowering therapy who have uncontrolled gout.1

    "We are thrilled to advance ALLN-346, our second product candidate, into the clinic. Like reloxaliase, ALLN-346 was designed using our proprietary oral enzyme technology platform. Our goal is to create the first orally-delivered, non-absorbed, stable enzyme that degrades urate in the GI tract, in order to reduce the metabolic burden of urate on the kidney," said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. "This is another compelling application of our oral enzyme platform, as our scientific team continues to innovate and provide potential new treatments for patients with difficult metabolic diseases."

    This Phase 1 clinical trial is a randomized, double blind, placebo-controlled, single ascending dose study of orally administered ALLN-346 in approximately 24 healthy volunteers. The primary objective of the study is to assess safety and tolerability over 28 days. Allena expects to report initial clinical data in the fourth quarter of 2020, subject to the impact of COVID-19. For more information about the clinical trial design, please visit: www.clinicaltrials.gov (NCT04236219).

    At the 2018 American College of Rheumatology (ACR/ARHP) Annual Meeting, Allena presented preclinical proof-of-concept data for ALLN-346, demonstrating urate reduction in a urate oxidase knock-out mouse model, an animal model of severe hyperuricemia with kidney damage due to urate crystal deposition. After one week of treatment, mice treated with ALLN-346 achieved a substantial reduction in urate burden on the kidney, as evidenced by normalization in urine uric acid and a significant reduction in plasma urate. These data were subsequently supported in a porcine model with acutely induced hyperuricemia that was presented at the ACR/ARHP Annual Meeting in 2019.

    "Patients with gout and moderate-to-severe CKD are in need of new therapeutic options, which can help lower the levels of uric acid in their blood and urine and help limit painful flares of gouty arthritis and potentially limit kidney stones. The oral therapies available to treat hyperuricemia in gout patients all are limited by CKD in their dosing and efficacy, and boosting convenient oral uric acid lowering therapies with this approach is compelling," said Robert Terkeltaub, M.D., Professor of Medicine at University of California San Diego. "By leveraging the gut-kidney-axis, ALLN-346 relies on a novel mechanism of action, which corresponds to the underlying physiology of hyperuricemia and the extrarenal pathway for uric acid elimination. There is potential for improved reduction in uric acid burden in gout patients with moderate-to-severe CKD." 

    About Hyperuricemia

    Hyperuricemia, or elevated levels of uric acid in the blood, results from overproduction or insufficient excretion of urate, or often a combination of the two. Hyperuricemia is associated with gout, a kind of arthritis caused by excess uric acid in the blood that leads to the formation of hard crystals in the joints. Hyperuricemia can also lead to increased uric acid excretion in the urine and subsequently to kidney stone formation and kidney damage also known as urate nephropathy. In addition, hyperuricemia has been linked to hypertension, CKD, glucose intolerance, dyslipidemia, insulin resistance and obesity.

    About ALLN-346

    ALLN-346 is an investigational, orally administered, novel, engineered urate oxidase that has been optimized for stability in the GI tract and high production yield. Allena has designed ALLN-346 to degrade urate in the GI tract and in turn, reduce the urate burden on the kidney and lower the risk of urate-related complications. ALLN-346 is targeted to lower serum uric acid in patients with CKD, whose renal function is decreased and who have diminished capacity for urinary excretion of uric acid. In September 2020, Allena announced first enrollment in a Phase 1 clinical trial of ALLN-346 and expects to report initial clinical data in the fourth quarter of 2020.

    About Allena Pharmaceuticals

    Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346, currently being evaluated in a Phase 1 clinical trial, for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the Allena's development of ALLN-346 and the Phase 1 clinical trial, statements regarding implementation of the amended trial design for URIROX-2 , the timing of sample size reassessments and interim analyses during the URIROX-2 trial, Allena's ability to utilize the accelerated approval regulatory pathway for reloxaliase, the impact of the COVID-19 coronavirus on Allena's business, the biotech sector generally and the broader macroeconomic environment, statements concerning the future clinical, regulatory and commercial potential of reloxaliase statements regarding Allena's financial position and need for capital. Any forward-looking statements in this press release 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: market and other conditions, the timing for completion of Allena's clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena's financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena's dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Item 1A of Part I of Allena's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

    Investor Contact

    Hannah Deresiewicz

    Stern Investor Relations, Inc.

    212-362-1200


    1 Lim, J., Fu, A., Reasner, D. & Taylor, D. (2017, April). Prevalence of CKD and Uncontrolled Gout Among US Adults: Results From NHANES 2007–2012. Poster presented at the National Kidney Foundation Spring Clinical Meetings, Orlando, FL.

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  2. NEWTON, Mass., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that company management will participate in fireside chats at two investor conferences in September:

    Baird 2020 Global Healthcare Conference
    Date: Thursday, September 10
    Time: 9:40 a.m. ET

    H.C. Wainwright & Co. 22nd Annual Global Investor Conference
    Date: Tuesday, September 15
    Time: 12:30 p.m. ET

    Live audio webcasts of the presentations will be available under "Events and Presentations" in the Investors section of the Company's website at…

    NEWTON, Mass., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that company management will participate in fireside chats at two investor conferences in September:

    Baird 2020 Global Healthcare Conference

    Date: Thursday, September 10

    Time: 9:40 a.m. ET

    H.C. Wainwright & Co. 22nd Annual Global Investor Conference

    Date: Tuesday, September 15

    Time: 12:30 p.m. ET

    Live audio webcasts of the presentations will be available under "Events and Presentations" in the Investors section of the Company's website at www.allenapharma.com. Replays of the webcasts will be available on the Allena website for 30 days following each presentation.

    About Allena Pharmaceuticals

    Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is a first in class, oral enzyme therapeutic for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.

    Investor Contact

    Hannah Deresiewicz

    Stern Investor Relations, Inc.

    212-362-1200

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

    Primary Logo

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  3. -- Expanding URIROX-2 Trial Sites; Interim Analysis on Track for the First Quarter of 2022 –-

    -- Initiated Phase 1 Clinical Trial of ALLN-346; Initial Data Expected in the Fourth Quarter of 2020 –-

    -- Raised Gross Proceeds of $22.7M Through Two Public Offerings, Extending Cash Runway Beyond the Second Quarter of 2021 –-

    NEWTON, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today reported financial results for the second quarter ended June 30, 2020 and provided a business update.

    -- Expanding URIROX-2 Trial Sites; Interim Analysis on Track for the First Quarter of 2022 –-

    -- Initiated Phase 1 Clinical Trial of ALLN-346; Initial Data Expected in the Fourth Quarter of 2020 –-

    -- Raised Gross Proceeds of $22.7M Through Two Public Offerings, Extending Cash Runway Beyond the Second Quarter of 2021 –-

    NEWTON, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today reported financial results for the second quarter ended June 30, 2020 and provided a business update.

    "In concert with our recent financings, our team has moved quickly to implement planned activities across our portfolio, including the expansion of URIROX-2 clinical trial sites and the initiation of our Phase 1 study of ALLN-346. We are grateful for the effort and attention of our URIROX-2 trial investigators and business partners, which has enabled us to enroll patients in this second Phase 3 trial, even in the midst of the pandemic.  This is the final study necessary for filing and approval of reloxaliase as a first-in-class therapy for patients with enteric hyperoxaluria," said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. "We are also excited to announce the initiation of our first-in-human study of ALLN-346, our second novel, oral enzyme therapeutic.  We are initially developing ALLN-346 for the treatment of renally impaired patients with hyperuricemia and gout, for whom existing treatment options are inadequate due to safety and dosing limitations. As we look to the second half of 2020, we remain on track to achieve all of our clinical development milestones, with initial data for ALLN-346 expected by year end and the first interim analysis from URIROX-2 expected in the first quarter of 2022." 

    Recent Business Highlights and Upcoming Milestones:

    Reloxaliase: Reloxaliase is a first-in-class, non-absorbed, orally administered enzyme for the treatment of severe hyperoxaluria. Allena is currently evaluating reloxaliase for patients with enteric hyperoxaluria (EH) in URIROX-2, the second pivotal Phase 3 clinical trial in its URIROX program. Allena is actively expanding to new sites and new geographies in its ongoing URIROX-2 clinical trial. The Company continues to expect the interim analysis in the first quarter of 2022 and to announce topline data supporting a potential Biologics License Application (BLA) submission in the third quarter of 2022.

    Allena continues to engage with the U.S. Food and Drug Administration (FDA) to explore potential expedited registration paths for reloxaliase in patients with EH and advanced chronic kidney disease (CKD).

    ALLN-346: ALLN-346 is a first-in-class, orally administered, novel urate degrading enzyme that has been designed for activity and stability in the gastrointestinal tract for the treatment of hyperuricemia in patients with gout in the setting of advanced CKD. In July 2020, Allena initiated a Phase 1 clinical trial of ALLN-346.  Initial data is expected in the fourth quarter of 2020.

    Corporate: In June 2020, Allena completed a registered direct offering of common stock and, in July 2020, an underwritten offering of common stock. Together, these transactions netted gross proceeds to Allena of $22.7 million.

    Second Quarter 2020 Financial Results:

    • Cash Position: As of June 30, 2020, cash and cash equivalents were $26.5 million, as compared to $30.0 million as of December 31, 2019. This decrease was primarily due to cash used in operating activities and payments of principal and interest made on the Company's credit facility, partially offset by gross proceeds of approximately $15.0 million received from the company's June 2020 registered direct offering. Cash and cash equivalents as of June 30, 2020 do not include gross proceeds of approximately $7.7 million received from the company's bought deal offering, which closed in July 2020.
    • R&D Expenses: R&D expenses were $3.8 million for the second quarter of 2020 as compared to $8.6 million for the second quarter of 2019. The decrease was primarily due to a reduction of costs incurred for the reloxaliase program, including costs for the URIROX-1 and URIROX-2 trials, and a reduction of costs incurred for the ALLN-346 program, including costs for formulation and development relating to its investigational new drug (IND) application.  During the fourth quarter of 2019, the Company completed its URIROX-1 trial and filed an IND for ALLN-346 with the FDA.
    • G&A Expenses: G&A expenses were $2.8 million for the second quarter of 2020 as compared to $2.7 million for the second quarter of 2019. This increase was due to increases in compensation and benefit costs, the majority of which were related to stock-based compensation, partially offset by decreases in consulting and professional services costs.
    • Net Loss: Net loss was $7.0 million for the second quarter of 2020, or a net loss per basic and diluted share of $0.26, as compared to a net loss of $11.3 million for the second quarter of 2019, or a net loss per basic and diluted share of $0.54. 

    Financial Guidance:

    Based on its current plans, Allena expects that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements beyond the second quarter of 2021.

    About Allena Pharmaceuticals

    Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the statements regarding implementation of the amended trial design for URIROX-2 , the timing of sample size reassessments and interim analyses during the URIROX-2 trial, Allena's ability to utilize the accelerated approval regulatory pathway for reloxaliase, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding the Allena's development of ALLN-346, statements regarding Allena's financial position and need for capital. In addition, it should be noted that additional capital will be required to complete the planned URIROX-2 clinical trial, including the planned interim analysis at the first sample size reassessment, which capital may not be available to Allena on terms that are acceptable to it, if at all. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase. The impact of the COVID-19 coronavirus on Allena's business, the biotech sector generally and the broader macroeconomic environment is uncertain and could harm Allena's business by delaying regulatory review timelines, clinical development plans and our ability to raise necessary capital. Furthermore, Allena does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern. Allena will require additional capital to fund its planned operations, which may not be available to it on attractive terms or at all. If the company is unable to secure additional capital, it will be forced to delay, limit, reduce or terminate its development of reloxaliase and may not be able to continue as a going concern. Any forward-looking statements in this press release 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 risk that the results of the URIROX-1 clinical trial may not be replicated in the URIROX-2 or other clinical trials of reloxaliase; the risk that the reduction in 24-hour UOx excretion observed in the placebo arm of the URIROX-1 trial may be observed in the URIROX-2 or other clinical trials of reloxaliase, which may have a negative impact on Allena's ability to secure regulatory approval for this product candidate; the risk that results of earlier studies, or interim results, may not be predictive of future clinical trial results, and planned and ongoing studies may not establish an adequate safety or efficacy profile for reloxaliase to support regulatory approval or the use of the accelerated approval regulatory pathway; risks related to Allena's ability to utilize the accelerated approval pathway for reloxaliase, including the risk that available data at the time of any sample size re-estimation or interim analysis conducted during the URIROX-2 trial may not be sufficient to demonstrate an increased probability of kidney stone events in patients with enteric hyperoxaluria and increasing UOx levels; the risk that the FDA may require that Allena increase the sample size or duration of treatment following the sample size reassessments to be conducted in accordance with the adaptive design element of the trial or otherwise collect additional clinical data from the URIROX-2 or other clinical trials prior to submitting a BLA for reloxaliase; risks associated with Allena's ability to enroll a sufficient number of patients to adequately power URIROX-2 in order to achieve ultimate statistical success for kidney stone disease progression in the long-term follow-up phase of the trial; risks related to Allena's use of UOx and/or POx as surrogate endpoints in its ongoing clinical trials, neither of which it believes have been previously utilized as biomarkers to support regulatory approval of other drug candidates, and the risks related to validating that reductions in UOx and/or POx correlate with meaningful clinical benefit; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena's financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena's dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Item 1A of Part I of Allena's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

     
    Allena Pharmaceuticals, Inc
    Selected Condensed Consolidated Balance Sheet Data
    (in thousands)
    (unaudited)
         
      As of

    June 30, 2020
     As of

    December 31, 2019
    Cash and cash equivalents $  26,453 $  30,007
    Working capital (1)    21,633    22,127
    Total assets    29,108    34,108
    Loan payable, net of current portion and discount    3,992    5,988
    Total stockholders' equity    18,373    17,198
         
    (1) The Company defines working capital as current assets less current liabilities.  See the Company's condensed consolidated financial statements for further detail regarding its current assets and current liabilities.



     
    Allena Pharmaceuticals, Inc
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
            
     For the Three Months Ended

    June 30,
     For the Six Months Ended

    June 30,
      2020   2019   2020   2019 
    Operating expenses:       
    Research and development$  3,808  $  8,589  $  8,454  $  17,717 
    General and administrative   2,751     2,746     5,629     5,177 
    Total operating expenses   6,559     11,335     14,083     22,894 
    Other income (expense), net   (417)    62     (478)    202 
    Net loss$  (6,976) $  (11,273) $  (14,561) $  (22,692)
    Net loss per share attributable to common stockholders—basic and diluted$  (0.26) $  (0.54) $  (0.56) $  (1.09)
    Weighted-average common shares outstanding—basic and diluted   26,878,962     20,903,298     25,808,043     20,859,251 
     

    Investor Contact

    Hannah Deresiewicz

    Stern Investor Relations, Inc.

    212-362-1200

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

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  4. NEWTON, Mass., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that Louis Brenner, M.D., Allena's President and Chief Executive Officer, will present a corporate overview at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020, at 8:35 a.m. ET.  

    A live audio webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Company's website at www.allenapharma.com. A replay of the webcast will be available on the Allena website…

    NEWTON, Mass., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that Louis Brenner, M.D., Allena's President and Chief Executive Officer, will present a corporate overview at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020, at 8:35 a.m. ET.  

    A live audio webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Company's website at www.allenapharma.com. A replay of the webcast will be available on the Allena website for 30 days following the presentation.

    About Allena Pharmaceuticals

    Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.

    Investor Contact

    Hannah Deresiewicz

    Stern Investor Relations, Inc.

    212-362-1200

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

    Primary Logo

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  5. NEWTON, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, announced today that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 3,846,154 shares of common stock of the Company, at a price to the public of $1.30 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about July 30, 2020, subject to satisfaction of customary closing conditions.

    H.C. Wainwright…

    NEWTON, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, announced today that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 3,846,154 shares of common stock of the Company, at a price to the public of $1.30 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about July 30, 2020, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to an additional 576,923 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Allena, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter's option to purchase additional common stock, are expected to be approximately $5.0 million. The Company intends to use the net proceeds from this offering for working capital and other general corporate purposes. 

    The shares of common stock are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-228656) previously filed with the Securities and Exchange Commission (the "SEC") on December 3, 2018, and declared effective by the SEC on December 26, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to, the and describing the terms of, the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov .  Electronic copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or e-mail at .

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

    About Allena Pharmaceuticals

    Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena's lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic candidate for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the completion of the public offering, the satisfaction of customary closing conditions related to the public offering and the intended use of net proceeds from the public offering, statements regarding implementation of the amended trial design for URIROX-2 , the timing of sample size reassessments and interim analyses during the URIROX-2 trial, Allena's ability to utilize the accelerated approval regulatory pathway for reloxaliase, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding the Allena's development of ALLN-346, statements regarding Allena's financial position and need for capital. In addition, it should be noted that additional capital will be required to complete the planned URIROX-2 clinical trial, including the planned interim analysis at the first sample size reassessment, which capital may not be available to Allena on terms that are acceptable to it, if at all. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase. The impact of the COVID-19 coronavirus on Allena's business, the biotech sector generally and the broader macroeconomic environment is uncertain and could harm Allena's business by delaying regulatory review timelines, clinical development plans and our ability to raise necessary capital. Furthermore, Allena does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern. Allena will require additional capital to fund its planned operations, which may not be available to it on attractive terms or at all. If the company is unable to secure additional capital, it will be forced to delay, limit, reduce or terminate its development of reloxaliase and may not be able to continue as a going concern. Any forward-looking statements in this press release 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: market and other conditions, the risk that the results of the URIROX-1 clinical trial may not be replicated in the URIROX-2 or other clinical trials of reloxaliase; the risk that the reduction in 24-hour UOx excretion observed in the placebo arm of the URIROX-1 trial may be observed in the URIROX-2 or other clinical trials of reloxaliase, which may have a negative impact on Allena's ability to secure regulatory approval for this product candidate; the risk that results of earlier studies, or interim results, may not be predictive of future clinical trial results, and planned and ongoing studies may not establish an adequate safety or efficacy profile for reloxaliase to support regulatory approval or the use of the accelerated approval regulatory pathway; risks related to Allena's ability to utilize the accelerated approval pathway for reloxaliase, including the risk that available data at the time of any sample size re-estimation or interim analysis conducted during the URIROX-2 trial may not be sufficient to demonstrate an increased probability of kidney stone events in patients with enteric hyperoxaluria and increasing UOx levels; the risk that the FDA may require that Allena increase the sample size or duration of treatment following the sample size reassessments to be conducted in accordance with the adaptive design element of the trial or otherwise collect additional clinical data from the URIROX-2 or other clinical trials prior to submitting a BLA for reloxaliase; risks associated with Allena's ability to enroll a sufficient number of patients to adequately power URIROX-2 in order to achieve ultimate statistical success for kidney stone disease progression in the long-term follow-up phase of the trial; risks related to Allena's use of UOx and/or POx as surrogate endpoints in its ongoing clinical trials, neither of which it believes have been previously utilized as biomarkers to support regulatory approval of other drug candidates, and the risks related to validating that reductions in UOx and/or POx correlate with meaningful clinical benefit; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena's financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena's dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Item 1A of Part I of Allena's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

    Investor Contact

    Hannah Deresiewicz

    Stern Investor Relations, Inc.

    212-362-1200

    Media Contact

    Adam Daley

    Berry & Company Public Relations

    212-253-8881

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