ELYM Eliem Therapeutics Inc

9.48
+0.38  (+4%)
Previous Close 9.1
Open 8.83
52 Week Low 8.02
52 Week High 29.69
Market Cap $251,734,916
Shares 26,554,316
Float 8,215,967
Enterprise Value $105,716,915
Volume 85,236
Av. Daily Volume 54,293
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Upcoming Catalysts

Drug Stage Catalyst Date
ETX-810
Diabetic peripheral neuropathic pain (DPNP)
Phase 2a
Phase 2a
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ETX-155
Focal onset seizures (FOS)
Phase 1b
Phase 1b
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ETX-810
Lumbosacral radiculopathy (sciatica)
Phase 2a
Phase 2a
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ETX-155
Perimenopausal depression (PMD)
Phase 2a
Phase 2a
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ETX-155
Major depressive disorder (MDD)
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
ETX-155
Epylepsy
Phase 1b
Phase 1b
Phase 1b proof-of-concept study enrollment ongoing, noted January 18, 2022. Phase 1b interim data expected 1H 2022.

Latest News

  1. ETX-810 Phase 2a trial in diabetic peripheral neuropathic pain (DPNP) is fully enrolled

    Investigational New Drug (IND) application planned in Q1 2022 for ETX-155 Phase 2 trials in major depressive disorder (MDD) and perimenopausal depression (PMD)

    Patient dosing underway for ETX-155 Phase 1b proof-of-concept study in epilepsy

    SEATTLE and CAMBRIDGE, United Kingdom, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc. (NASDAQ:ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today is providing program updates and announcing expected milestones…

    ETX-810 Phase 2a trial in diabetic peripheral neuropathic pain (DPNP) is fully enrolled

    Investigational New Drug (IND) application planned in Q1 2022 for ETX-155 Phase 2 trials in major depressive disorder (MDD) and perimenopausal depression (PMD)

    Patient dosing underway for ETX-155 Phase 1b proof-of-concept study in epilepsy

    SEATTLE and CAMBRIDGE, United Kingdom, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc. (NASDAQ:ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today is providing program updates and announcing expected milestones.

    "We continue to advance multiple programs in our pipeline, and we recently fully enrolled our Phase 2a trial of ETX-810 in patients with chronic diabetic peripheral neuropathic pain," said Bob Azelby, president and chief executive officer of Eliem Therapeutics. "Positive clinical data with this novel product candidate, if it receives regulatory approval, could provide new options for the millions of patients suffering from chronic pain, a therapeutic area that has not seen meaningful innovation in decades. Additionally, we look forward to evaluating ETX-155 in patients with depression and epilepsy, as it is based on a clinically validated mechanism of action and has potentially differentiated product attributes. As a small biotech, we believe we are in a unique position to progress two clinical stage assets, each addressing multiple indications in large markets."

    Program Updates and Anticipated Key Milestones

    ETX-810 in chronic pain: ETX-810 is a novel, new chemical entity prodrug of the bioactive lipid palmitoylethanolamide that is currently being evaluated in two Phase 2a clinical trials in subjects with diabetic peripheral neuropathic pain (DPNP) and lumbosacral radicular pain (LSRP), commonly referred to as sciatica.

    • ETX-810 in DPNP. Achieved full enrollment in the Phase 2a prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy and safety of ETX-810 in subjects with DPNP. The Company expects topline data in the first half of 2022.
    • ETX-810 in LSRP. Enrollment is ongoing for the Phase 2a prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy and safety of ETX-810 in subjects with LSRP. The Company expects enrollment to be completed in the first half of 2022 and now expects topline data in the second half of 2022.

    ETX-155 in depression and epilepsy: ETX-155 is a novel GABAA receptor positive allosteric modulator that Eliem plans to evaluate in subjects with major depressive disorder (MDD), perimenopausal depression (PMD), and epilepsy.

    • ETX-155 in MDD and PMD. The Company expects to submit an IND application with the U.S. Food and Drug Administration (FDA) in Q1 2022. There was a delay in the Company's previously planned Q4 2021 IND submission due to the identification of an uncharacterized metabolite in December 2021. The Company is updating the IND application with a plan to characterize the metabolite. Assuming FDA clearance to proceed, the Company expects to dose the first subjects in two randomized, placebo-controlled, Phase 2a proof-of-concept trials of ETX-155 in the first half of 2022 and expects topline data in the second half of 2023.     
    • ETX-155 in epilepsy. Enrollment is ongoing for the single-arm Phase 1b trial in subjects with photosensitive epilepsy (PSE), a single dose proof-of-concept study for epilepsy. The Company expects interim data in the first half of 2022. 

    Kv7.2/3 channel opener program: The Company's preclinical program targets the Kv7.2/3 potassium channel, a target that has been shown to control neuronal excitability and that has clinical validation in pain and epilepsy. The Company plans to progress IND-enabling studies in 2022. 

    Anxiolytic for generalized anxiety disorder (GAD): The Company is in early preclinical development of a novel, rapid-acting, non-sedating, non-addictive anxiolytic for the potential treatment of GAD. The Company is continuing the preclinical development of this program with the intent to provide a development plan update later in 2022.

    Cash Guidance

    The Company's unaudited cash, cash equivalents and marketable securities were approximately $160 million as of December 31, 2021. The Company continues to expect that its current cash, cash equivalents and marketable securities will be sufficient to fund operations through late 2023.

    Upcoming Investor Events

    • Eliem will present at the Virtual 11th Annual SVB Leerink Global Healthcare Conference 2022 being held February 14-18.
    • In Q1 2022, Eliem plans to host a virtual investor day to discuss the chronic pain treatment landscape, unmet clinical needs in chronic pain, and ETX-810's clinical program and potential commercial opportunity. The Company will announce details for the event when they are finalized, and a webcast of the event will be available on the Company's website.

    About Eliem Therapeutics, Inc.

    Eliem Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems. These disorders often occur when neurons are overly excited or inhibited, leading to an imbalance, and our focus is on restoring homeostasis. We are developing a pipeline of clinically differentiated product candidates focused on validated mechanisms of action with broad therapeutic potential to deliver improved therapeutics for patients with these disorders. Eliem channels its experience, energy, and passion for improving patients' quality of life to fuel our efforts to develop life-changing novel therapies. At its core, the Eliem team is motivated by the promise of helping patients live happier, more fulfilling lives.

    https://eliemtx.com/

    Forward-Looking Statements

    This press release contains forward-looking statements, including, without limitation, statements relating to: expected milestones; the continued development and clinical and therapeutic potential ETX-155 and ETX-810; Eliem's plans to initiate clinical trials of ETX-155 and the timing thereof; anticipated data readouts of ETX-810 and ETX-155 and the timing thereof; timing of regulatory filings and approvals; the progression of the Kv7.2/3 and next-generation anxiolytic preclinical programs; the expectation that Eliem's current cash, cash equivalents and marketable securities will fund operations through late 2023; and Eliem's commitment to developing therapies targeting debilitating disorders. Words such as "expected," "continue," "advance," "could," "options," "look forward," "believe," "progress," "anticipated," "plans," "assuming," "guidance," "will," "sufficient," or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Eliem's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the clinical, therapeutic and commercial value of ETX-810, ETX-155 and Eliem's preclinical programs; risks related to the potential failure of ETX-810 and ETX-155 to demonstrate safety and efficacy in clinical testing; Eliem's ability to initiate and conduct clinical trials and studies of ETX-810 and ETX-155 sufficient to achieve a positive completion; the availability of data at the expected times; Eliem's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Eliem's preclinical and clinical development activities; the sufficiency of Eliem's capital and other resources; risks and uncertainties related to regulatory application, review and approval processes and Eliem's compliance with applicable legal and regulatory requirements; market competition; changes in economic and business conditions; impacts on Eliem's business due to health pandemics or other contagious outbreaks, such as the current COVID-19 pandemic; and other factors discussed under the caption "Risk Factors" in Eliem's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021. This filing is available on the SEC's website at www.sec.gov. Additional information will also be set forth in Eliem's other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Eliem expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Eliem's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Investors

    Chris Brinzey

    ICR Westwicke



    339-970-2843

    Media

    Marites Coulter

    Verge Scientific



    415.819.2214



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  2. Advanced ETX-155 clinical development program, with the first subject successfully screened in epilepsy proof-of-concept trial and significant progress made toward the initiation of major depressive disorder (MDD) and perimenopausal depression (PMD) clinical trials

    Continued to enroll ETX-810's two Phase 2a chronic pain clinical trials, with topline data anticipated in the first half of 2022

    On track to progress Kv7.2/3 channel opener program into Investigational New Drug (IND)-enabling studies in the first half of 2022

    SEATTLE and CAMBRIDGE, United Kingdom, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc. (NASDAQ:ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability…

    Advanced ETX-155 clinical development program, with the first subject successfully screened in epilepsy proof-of-concept trial and significant progress made toward the initiation of major depressive disorder (MDD) and perimenopausal depression (PMD) clinical trials

    Continued to enroll ETX-810's two Phase 2a chronic pain clinical trials, with topline data anticipated in the first half of 2022

    On track to progress Kv7.2/3 channel opener program into Investigational New Drug (IND)-enabling studies in the first half of 2022

    SEATTLE and CAMBRIDGE, United Kingdom, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc. (NASDAQ:ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today reported financial results and business highlights for the quarter ended September 30, 2021.

    "Our clinical execution is progressing well," said Bob Azelby, Eliem's president and chief executive officer. "For ETX-155, we are excited to report that we have completed our Phase 1 studies, we have successfully screened our first patient in our photosensitive epilepsy (PSE) proof-of-concept clinical trial and we continue to progress clinical development activities for the launch of our phase 2a trials evaluating ETX-155 in patients with MDD and PMD. As we look to expand our clinical pipeline, we are increasingly excited about the potential of our Kv7.2/3 channel opener program as a clinically validated mechanistic approach to treat diseases such as epilepsy, pain and MDD, and we remain on track to progress the program into IND-enabling studies in the first half of 2022."

    Third Quarter 2021 Highlights and Recent Developments

    Completed 14-day repeat dose Phase 1 study demonstrating ETX-155 was well tolerated with an approximate 40-hour half-life supporting once-daily dosing. The 14-day, repeat dose, Phase 1 study evaluated the pharmacokinetic profile and safety of ETX-155 in 20 healthy human subjects, evaluating 60 mg ETX-155 (n=15) or placebo (n=5) dosed daily in the evening for 14 days. Results demonstrated ETX-155 reached steady state concentration at Day 8 and had an approximate 40-hour half-life, confirming ETX-155's desirable profile for a once-daily dosing regimen. The study also confirmed that ETX-155 was generally well tolerated with no severe or serious adverse events, or discontinuations. All treatment-emergent adverse events (TEAEs), including central nervous system (CNS) adverse events, were mild/moderate and transient. In particular, all somnolence adverse events were mild and the incidence was comparable in the ETX-155 and placebo groups. Notably, somnolence events were sporadic, and no subject who reported somnolence in either the ETX-155 or placebo arms reported it more than once during the dosing or follow-up period. In addition, there was no clinically meaningful difference compared to placebo in sleep quality or next morning state of arousal, as measured by the Leeds Sleep Evaluation Questionnaire. The tolerability and safety findings of this study were consistent with those of the previous 7-day repeat dose and single ascending dose Phase 1 study. Collectively, the Company's Phase 1 studies have demonstrated that ETX-155 has differentiated pharmacokinetic properties, including no clinically meaningful food effect and an approximate 40-hour half-life to enable a once-daily dosing regimen.

    Screened the first subject in ETX-155 photosensitive epilepsy clinical trial: The Company anticipates dosing the first subject in the single-arm proof-of-concept Phase 1b PSE trial by the end of 2021. Precedent literature demonstrates that activity in single-dose PSE trials can be a reliable predictor of anticonvulsant activity in various forms of epilepsy, such as focal onset seizure.

    Advanced study start-up activities for ETX-155 Phase 2a clinical trials in MDD and PMD: The Company anticipates dosing the first subject in each of these studies in early 2022, assuming regulatory approval of its IND application.

    Program Updates and Anticipated Milestones

    ETX-810 in chronic pain:  ETX-810 is a novel new chemical entity prodrug of the bioactive lipid palmitoylethanolamide that is currently being evaluated in two Phase 2a clinical trials in subjects with diabetic peripheral neuropathic pain (DPNP) and lumbosacral radicular pain (LSRP), commonly referred to as sciatica.

    • ETX-810 in DPNP.  The ongoing Phase 2a prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy and safety of ETX-810 in subjects with DPNP remains on track to have topline data readout during the first half of 2022.

       
    • ETX-810 in LSRP.  The ongoing Phase 2a prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy and safety of ETX-810 in subjects with LSRP remains on track to have topline data readout during the first half of 2022.

    ETX-155 in depression and epilepsy:  ETX-155 is a novel GABAA receptor positive allosteric modulator (PAM) that Eliem plans to evaluate in subjects with MDD, PMD and focal onset seizure (FOS).

    • ETX-155 in FOS.  The Company expects to report topline data from its ongoing single-arm, proof-of-concept Phase 1b trial in subjects with PSE in the first half of 2022. This study is intended to support progression into a Phase 2 study in FOS, given precedent literature demonstrating that activity in single dose PSE trials can be a reliable predictor of anticonvulsant activity in focal onset seizure.



    • ETX-155 in MDD and PMD.  Assuming regulatory approval of the Company's IND application, the Company expects to dose its first subjects in two randomized, placebo-controlled, Phase 2a proof-of-concept trials of ETX-155 in early 2022. Topline data from each trial is expected in the first half of 2023.

    Kv7.2/3 channel opener program: The Company's preclinical program targets the Kv7.2/3 potassium channel that has been shown to control neuronal excitability, with clinical validation in pain and epilepsy. The program remains on track to progress to IND-enabling studies in the first half of 2022. 

    Anxiolytic for generalized anxiety disorder (GAD):  The Company is also in early preclinical development of a novel, rapid-acting, non-sedating, non-addictive anxiolytic for the potential treatment of GAD, based on a clinically validated mechanism. The Company plans to continue the preclinical development of this program in 2022.

    Third Quarter 2021 Financial Results

    • Cash Position:  Cash, cash equivalents and marketable securities was $169.6 million as of September 30, 2021, as compared to $99.5 million as of June 30, 2021. This includes net proceeds from the Company's August 2021 initial public offering.  The Company's current cash, cash equivalents and marketable securities are expected to fund operations through late 2023.
    • Research and Development (R&D) expenses:  R&D expenses were $6.0 million for the three months ended September 30, 2021, compared to $1.9 million for the same period in 2020.
    • General and Administrative (G&A) expenses:  G&A expenses were $3.4 million for the three months ended September 30, 2021, compared to $0.3 million for the same period in 2020.
    • Net loss:  Net loss was $9.6 million for the three months ended September 30, 2021, compared to $2.3 million for the same period in 2020.

    About Eliem Therapeutics, Inc.

    Eliem Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems. These disorders often occur when neurons are overly excited or inhibited, leading to an imbalance, and our focus is on restoring homeostasis. We are developing a pipeline of clinically differentiated product candidates focused on validated mechanisms of action with broad therapeutic potential to deliver improved therapeutics for patients with these disorders. Eliem channels its experience, energy, and passion for improving patients' quality of life to fuel our efforts to develop life-changing novel therapies. At its core, the Eliem team is motivated by the promise of helping patients live happier, more fulfilling lives.

    https://eliemtx.com/

    Forward-Looking Statements

    This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical and therapeutic potential ETX-155 and ETX-810; Eliem's plans to initiate clinical trials of ETX-155 and the timing thereof; anticipated data readouts of ETX-810 and ETX-155 and the timing thereof; the progression of the Kv7.2/3 and next-generation anxiolytic preclinical programs; the expectation that Eliem's current cash, cash equivalents and marketable securities will fund operations through late 2023; and Eliem's commitment to developing therapies targeting debilitating disorders. Words such as "on track," "advance," "progress," "toward," "continue," "excited," "potential," "expand," "anticipate," "milestones," "expect," "demonstrates," "intended," "plans," "runway," "initiate," "support," "enable," or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Eliem's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the clinical, therapeutic and commercial value of ETX-810, ETX-155 and Eliem's preclinical programs; risks related to the potential failure of ETX-810 and ETX-155 to demonstrate safety and efficacy in clinical testing; Eliem's ability to initiate and conduct clinical trials and studies of ETX-810 and ETX-155 sufficient to achieve a positive completion; the availability of data at the expected times; Eliem's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Eliem's preclinical and clinical development activities; the sufficiency of Eliem's capital and other resources; risks and uncertainties related to Eliem's compliance with applicable legal and regulatory requirements; market competition; changes in economic and business conditions; impacts on Eliem's business due to health pandemics or other contagious outbreaks, such as the current COVID-19 pandemic; and other factors discussed under the caption "Risk Factors" in Eliem's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021. This filing, when available, is available on the SEC's website at www.sec.gov. Additional information will also be set forth in Eliem's other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Eliem expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Eliem's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Investors

    Chris Brinzey

    ICR Westwicke



    339-970-2843

    Media

    Marites Coulter

    Verge Scientific



    415.819.2214

     
    Eliem Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share amounts)

    (unaudited)
           
    Assets September 30, 2021  December 31, 2020 
    Current assets:      
    Cash and cash equivalents $62,819  $20,487 
    Short-term marketable securities  83,199    
    Prepaid expenses and other current assets  12,614   1,511 
    Total current assets $158,632  $21,998 
    Long-term marketable securities  23,619    
    Other long-term assets     2,633 
    Total assets $182,251  $24,631 
    Liabilities, Redeemable Convertible Preferred Stock, and Stockholders' Equity (Deficit)      
    Current liabilities:      
    Accounts payable  2,579   1,086 
    Accounts payable, related party     207 
    Accrued expenses  2,979   1,219 
    Accrued expenses, related party  32    
    Redeemable convertible preferred stock tranche liability     551 
    Total current liabilities $5,590  $3,063 
    Total liabilities $5,590  $3,063 
    Commitments and contingencies      
    Redeemable convertible preferred stock, $0.0001 par value, 10,000,000 and 12,909,389 shares authorized, 0 and 7,140,157 shares issued and outstanding with aggregate liquidation preference of $0 and $49,891 at September 30, 2021 and December 31, 2020, respectively     46,551 
    Stockholders' equity (deficit):      
    Common stock, $0.0001 par value per share, 250,000,000 and 40,000,000 shares authorized; 26,199,262 and 3,418,751 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively  3   1 
    Additional paid-in capital  241,747   3,152 
    Accumulated other comprehensive income  (18)   
    Accumulated deficit  (65,071)  (28,136)
    Total stockholders' equity (deficit) $176,661  $(24,983)
    Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) $182,251  $24,631 
             



     
    Eliem Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share amounts)

    (unaudited)
           
      Three Months Ended September 30,  Nine Months Ended September 30, 
      2021  2020  2021  2020 
    Operating expenses:            
    Research and development $5,704  $1,930  $15,455  $4,644 
    Research and development, related party  285   17   988   286 
    General and administrative  3,394   312   8,526   888 
    Total operating expenses  9,383   2,259   24,969   5,818 
    Loss from operations  (9,383)  (2,259)  (24,969)  (5,818)
    Other income (expense):            
    Change in fair value of redeemable convertible preferred stock tranche liability        (11,718)   
    Foreign currency gain (loss)  (252)  1   (268)  13 
    Other income, net  20      20    
    Total other income (expense)  (232)  1   (11,966)  13 
    Net loss $(9,615) $(2,258) $(36,935) $(5,805)
    Accretion of redeemable convertible preferred stock to redemption value and cumulative preferred stock dividends  (1,322)  (461)  (4,548)  (1,352)
    Net loss attributable to common stockholders $(10,937) $(2,719) $(41,483) $(7,157)
    Net loss per share attributable to common stockholders, basic and diluted $(0.70) $(1.46) $(5.49) $(3.85)
    Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, basic and diluted  15,585,611   1,863,860   7,554,300   1,859,713 
                     



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  3. SEATTLE and CAMBRIDGE, United Kingdom, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc., a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today announced that members of its senior management team are scheduled to participate in four upcoming investor conferences.

    Virtual Guggenheim 3rd Annual Neuro/Immunology Conference
    Dates: November 15-16, 2021
    1x1 meetings only

    Stifel 2021 Virtual Healthcare Conference
    Fireside Chat date: Wednesday, November 17, 2021
    Fireside Chat time: 2:00 p.m. ET

    33rd Annual Piper Sandler Virtual Healthcare Conference

    SEATTLE and CAMBRIDGE, United Kingdom, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc., a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today announced that members of its senior management team are scheduled to participate in four upcoming investor conferences.

    Virtual Guggenheim 3rd Annual Neuro/Immunology Conference

    Dates: November 15-16, 2021

    1x1 meetings only

    Stifel 2021 Virtual Healthcare Conference

    Fireside Chat date: Wednesday, November 17, 2021

    Fireside Chat time: 2:00 p.m. ET

    33rd Annual Piper Sandler Virtual Healthcare Conference

    Dates: November 30 - December 2, 2021

    An on-demand, pre-recorded, fireside chat will be made available on the conference website starting on Monday, November 22, 2021 at 10:00 a.m. ET

    Evercore ISI 4th Annual HealthCONx Virtual Conference

    Fireside Chat Date: Tuesday, November 30, 2021

    Fireside Chat Time: 1:00 p.m. ET

    A live webcast of the fireside chat at the Stifel 2021 Virtual Healthcare Conference and Evercore ISI 4th Annual HealthCONx Virtual Conference, along with a webcast of the pre-recorded fireside chat at the 33rd Annual Piper Sandler Virtual Healthcare Conference, will be available on the Investors section of the Eliem Therapeutics website at https://www.eliemtx.com. An archived replay of each of the events will remain available on Eliem's website for at least 30 days after the event.

    About Eliem Therapeutics, Inc.

    Eliem Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems. These disorders often occur when neurons are overly excited or inhibited, leading to an imbalance, and our focus is on restoring homeostasis. We are developing a pipeline of clinically differentiated product candidates focused on validated mechanisms of action with broad therapeutic potential to deliver improved therapeutics for patients with these disorders. Eliem channels its experience, energy, and passion for improving patients' quality of life to fuel our efforts to develop life-changing novel therapies. At its core, the Eliem team is motivated by the promise of helping patients live happier, more fulfilling lives.

    https://eliemtx.com/

    Investors

    Chris Brinzey

    ICR Westwicke

    e.com

    339-970-2843

    Media

    Marites Coulter

    Verge Scientific



    415.819.2214



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  4. On track to advance two clinical programs through five proof-of-concept trials and progress two preclinical programs over the next 18-24 months

    Recently completed an IPO for $92 million in gross proceeds that, along with existing cash, provides cash runway through late 2023

    SEATTLE and CAMBRIDGE, United Kingdom, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc., a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today reported financial results and business highlights for the quarter ended June 30, 2021.

    "It has been an exciting year thus…

    On track to advance two clinical programs through five proof-of-concept trials and progress two preclinical programs over the next 18-24 months

    Recently completed an IPO for $92 million in gross proceeds that, along with existing cash, provides cash runway through late 2023

    SEATTLE and CAMBRIDGE, United Kingdom, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc., a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today reported financial results and business highlights for the quarter ended June 30, 2021.

    "It has been an exciting year thus far for Eliem, highlighted by our successful initial public offering (IPO) that we completed in August," said Bob Azelby, Eliem's president and chief executive officer. "In the second quarter, we continued to advance enrollment on our two Phase 2a studies for ETX-810 in patients with chronic pain conditions. We also made excellent progress toward initiating three clinical studies for ETX-155 in depressive disorders and epilepsy. The proceeds from our IPO, along with the additional capital we raised in our Series B financing in May 2021, are expected to fund our operations through late 2023. We believe this funding will take us through multiple topline clinical data readouts across five different indications and also allows us to advance our preclinical pipeline. We remain committed to developing therapies targeting debilitating disorders that impact tens of millions of people worldwide every day."

    Recent Highlights and Upcoming Milestones

    Initial public offering raised $92 million gross proceeds: In August 2021, the Company announced the public offering of 7,360,000 shares of its common stock, including the exercise in full of the underwriters' option to purchase an additional 960,000 shares of common stock, at a public offering price of $12.50 per share. The Company received estimated net proceeds of $83.1 million from the IPO, after deducting underwriting discounts of $6.4 million and estimated offering costs of $2.5 million. The IPO was preceded by a Series B financing in May 2021 that raised gross proceeds of $60.0 million.

    Program Updates and Milestones

    ETX-810 in chronic pain: ETX-810 is a novel new chemical entity prodrug of the bioactive lipid palmitoylethanolamide (PEA) that is currently being evaluated in two Phase 2a clinical trials in patients with diabetic peripheral neuropathic pain (DPNP) and lumbosacral radicular pain (LSRP), commonly referred to as sciatica. ETX-810 was designed to optimize the oral absorption and systemic exposure of PEA, which is believed to play a critical role in the regulation of neuroinflammation and pain signaling in chronic pain.

    • ETX-810 in DPNP. The Company is conducting a Phase 2a prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the efficacy and safety of ETX-810 in adults with DPNP. The Company expects to have a topline data readout during the first half of 2022.
    • ETX-810 in LSRP. The Company is conducting a Phase 2a prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the efficacy and safety of ETX-810 in adults with LSRP. The Company expects to have a topline data readout during the first half of 2022.

    ETX-155 in depression and epilepsy: ETX-155 is a novel GABAA receptor positive allosteric modulator that Eliem plans to evaluate in patients with major depressive disorder (MDD), perimenopausal depression (PMD) and focal onset seizure (FOS). ETX-155 was designed to have broad potency across both synaptic and extrasynaptic GABAA receptor subtypes. In Phase 1 clinical studies to date, ETX-155 was shown to be well tolerated with desirable pharmacokinetic properties, including no clinically meaningful food effect and at least a 24-hour half-life to enable once-a-day-dosing. The Company believes these attributes combine to position it well within the GABAA PAM therapeutic class.

    • ETX-155 in FOS. The Company expects to initiate a single-arm, proof-of-concept Phase 1b trial in photosensitive epilepsy patients in the second half of 2021 with topline data expected by the first half of 2022.
    • ETX-155 in MDD. The Company expects to initiate a randomized, placebo-controlled, Phase 2a proof-of-concept trial of ETX-155 in the second half of 2021 with first patient dosed in early 2022 and topline data expected in the first half of 2023.
    • ETX-155 in PMD. The Company expects to initiate a randomized, placebo-controlled, Phase 2a proof-of-concept trial of ETX-155 in the second half of 2021 with first patient dosed in early 2022 and topline data expected in the first half of 2023.

    Preclinical Pipeline: The Company is progressing two preclinical programs currently in the discovery stage.

    • Kv7.2/3 in pain and epilepsy. The lead preclinical program targets the Kv7.2/3 potassium channel that has been shown to play a role in stabilizing the membrane potential of neuronal cells and controlling neuronal excitability. The Company plans to nominate a clinical candidate in the second half of 2021.
    • Anxiolytic for generalized anxiety disorder (GAD). The Company is also in early preclinical development of a novel, rapid-acting, non-sedating, non-addictive anxiolytic for the potential treatment of GAD. The Company plans to nominate a clinical candidate in 2022.

    Second Quarter 2021 Financial Results

    • Cash Position: Cash was $99.5 million as of June 30, 2021, as compared to $47.9 million as of March 31, 2021. This does not include an additional $83.1 million in net proceeds from the Company's IPO in August 2021.
    • Research and Development (R&D) expenses: R&D expenses were $5.8 million for the three months ended June 30, 2021, compared to $1.4 million for the same period in 2020.
    • General and Administrative (G&A) expenses: G&A expenses were $2.9 million for the three months ended June 30, 2021, compared to $0.2 million for the same period in 2020.
    • Net loss: Net loss was $8.7 million for the three months ended June 30, 2021, compared to $1.6 million for the same period in 2020.

    About Eliem Therapeutics, Inc.

    Eliem Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems. These disorders often occur when neurons are overly excited or inhibited, leading to an imbalance, and our focus is on restoring homeostasis. We are developing a pipeline of clinically differentiated product candidates focused on validated mechanisms of action with broad therapeutic potential to deliver improved therapeutics for patients with these disorders. Eliem channels its experience, energy, and passion for improving patients' quality of life to fuel our efforts to develop life-changing novel therapies. At its core, the Eliem team is motivated by the promise of helping patients live happier, more fulfilling lives.

    https://eliemtx.com/

    Forward-Looking Statements

    This press release contains forward-looking statements, including, without limitation, statements relating to: Eliem's plans to initiate clinical trials of ETX-155 and the timing thereof; anticipated data readouts of ETX-810 and ETX-155 and the timing thereof; the progression of the Kv7.2/3 and next-generation anxiolytic preclinical programs; the sufficiency of Eliem's current funds and anticipated cash runway through late 2023; and Eliem's commitment to developing therapies targeting debilitating disorders. Words such as "on track," "advance," "progress," "provides," "runway," "will," "enable," "expect," "believe," "plans," "initiate," or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Eliem's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the clinical, therapeutic and commercial value of ETX-810, ETX-155 and Eliem's preclinical programs; risks related to the potential failure of ETX-810 and ETX-155 to demonstrate safety and efficacy in clinical testing; Eliem's ability to initiate and conduct clinical trials and studies of ETX-810 and ETX-155 sufficient to achieve a positive completion; the availability of data at the expected times; Eliem's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Eliem's preclinical and clinical development activities; the sufficiency of Eliem's capital and other resources; risks and uncertainties related to Eliem's compliance with applicable legal and regulatory requirements; market competition; changes in economic and business conditions; impacts on Eliem's business due to health pandemics or other contagious outbreaks, such as the current COVID-19 pandemic; and other factors discussed under the caption "Risk Factors" in Eliem's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021. This filing, when available, is available on the SEC's website at www.sec.gov. Additional information will also be set forth in Eliem's other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Eliem expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Eliem's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    Investors

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    Media

    Marites Coulter

    Verge Scientific



    415.819.2214



    Eliem Therapeutics, Inc.


    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share amounts)

    (unaudited)

    Assets June 30, 2021  December 31, 2020 
    Current assets:      
    Cash $99,482  $20,487 
    Prepaid expenses and other current assets  5,321   1,511 
    Total current assets $104,803  $21,998 
    Long-term assets  2,824   2,633 
    Total assets $107,627  $24,631 
    Liabilities, Redeemable Convertible Preferred Stock, and

    Stockholders' Deficit
          
    Current liabilities:      
    Accounts payable  1,955   1,086 
    Accounts payable, related party     207 
    Accrued expenses  3,631   1,219 
    Accrued expenses, related party  127    
    Redeemable convertible preferred stock tranche liability     551 
    Total current liabilities $5,713  $3,063 
    Total liabilities $5,713  $3,063 
    Commitments and contingencies      
    Redeemable convertible preferred stock, $0.0001 par value, 15,345,286 and 12,909,389 shares authorized, 15,345,279 and 7,140,157 shares issued and outstanding with aggregate liquidation preference of $147,096 and $49,891 at June 30, 2021 and December 31, 2020, respectively  152,759   46,551 
    Stockholders' deficit:      
    Common stock, $0.0001 par value per share, 46,000,000 and 40,000,000 shares authorized; 3,489,956 and 3,418,751 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively  1   1 
    Additional paid-in capital  4,610   3,152 
    Accumulated deficit  (55,456)  (28,136)
    Total stockholders' deficit  (50,845)  (24,983)
    Total liabilities, redeemable convertible preferred stock, and stockholders' deficit $107,627  $24,631 







    Eliem Therapeutics, Inc.


    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share amounts)

    (unaudited)

      Three months ended June 30,  Six months ended June 30, 
      2021  2020  2021  2020 
    Operating expenses:            
    Research and development $5,478  $1,325  $9,751  $2,714 
    Research and development, related party  315   35   703   269 
    General and administrative  2,914   248   5,132   576 
    Total operating expenses  8,707   1,608   15,586   3,559 
    Loss from operations  (8,707)  (1,608)  (15,586)  (3,559)
    Other income (expense):            
    Change in fair value of redeemable convertible preferred stock tranche liability        (11,718)   
    Foreign currency gain (loss)  (12)  (23)  (16)  12 
    Total other income (expense)  (12)  (23)  (11,734)  12 
    Net loss and comprehensive loss $(8,719) $(1,631) $(27,320) $(3,547)
    Accretion of redeemable convertible preferred stock to redemption value and cumulative preferred stock dividends  (2,141)  (452)  (3,226)  (891)
    Net loss attributable to common stockholders $(10,860) $(2,083) $(30,546) $(4,438)
    Net loss per share attributable to common stockholders, basic and diluted $(3.11) $(1.12) $(8.80) $(2.39)
    Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, basic and diluted  3,488,017   1,859,703   3,472,086   1,857,617 


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  5. SEATTLE and CAMBRIDGE, United Kingdom, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc. (NASDAQ:ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in disorders of the peripheral and central nervous systems, today announced the closing of its initial public offering of 7,360,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 960,000 additional shares of common stock, at a public offering price of $12.50 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by Eliem, were $92.0…

    SEATTLE and CAMBRIDGE, United Kingdom, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Eliem Therapeutics, Inc. (NASDAQ:ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in disorders of the peripheral and central nervous systems, today announced the closing of its initial public offering of 7,360,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 960,000 additional shares of common stock, at a public offering price of $12.50 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by Eliem, were $92.0 million. All of the shares in the offering were sold by Eliem.

    SVB Leerink, Evercore ISI, Stifel, and Guggenheim Securities acted as joint bookrunning managers for the offering.

    Registration statements relating to these securities were filed with the Securities and Exchange Commission ("SEC") and became effective on August 9, 2021. Copies of the registration statements can be accessed through the SEC's website at www.sec.gov. The offering was made only by means of a written prospectus, forming a part of the effective registration statements. Copies of the final prospectus relating to the initial public offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at 800-808-7525 ext. 6105 or by email at ; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at ; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at ; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at .

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

    Investor Contact:

    Chris Brinzey

    Westwicke



    339.970.2843

    Media Contact:

    Marites Coulter

    VERGE Scientific Communications



    415.819.2214



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