ETX-018810

NRX-101 After an earlier stumble this year with its investigational major depressive disorder therapeutic, Eliem Therapeutics appears to be back on track with a planned Phase II study of ETX-155. After an earlier stumble this year with its investigational major depressive disorder therapeutic, Eliem Therapeutics is back on track with a planned Phase II study of ETX-155 , the company announced Wednesday. Based on interim results from the ongoing Phase I trial assessing ETX-155 in MDD, Eliem announced plans to initiate a Phase IIa study. The company stated a review of favorable safety, tolerability, pharmacokinetic pro preclinical data provided “the right exposure levels” that will allow the candidate to move into the next phase of development. The Seattle-based company previously delayed a plan to advance ETX-155 into Phase IIa following an inconclusive review of data from an early-stage study. ETX-155 is a novel GABAA receptor-positive allosteric modulator. In a Phase Ib trial, the company observed “lower-than-expected” drug exposure levels. Eliem, which launched last year , then initiated a Phase I study to confirm the pharmacokinetic pro ETX-155. Results found with the 60 mg dose, there was “no meaningful difference between exposures obtained with different batches,” the company reported. Eliem determined the low exposures observed in the Phase Ib study were within the previously reported moderate variability range. Additionally, the company reported no irregularities or differences observed with chemistry, manufacturing and controls associated with the therapeutic. In its announcement, Eliem noted it plans to assess a 75 mg dose of ETX-155 in the repeat dose part of the ongoing Phase I pharmacokinetic trial before announcing the dose that will be evaluated in the Phase IIa MDD study. Final results from the Phase I pharmacokinetic trial, including the repeat dose cohort, are expected in the fourth quarter of this year. A Phase IIa study could begin in the first quarter of 2023. ETX-155 will be moving forward into a crowded field of companies developing therapies for MDD. Earlier this year, Axsome Therapeutics won approval for Auvelity, the first oral N-methyl D-aspartate (NMDA) receptor antagonist approved for this indication. AbbVie submitted a supplemental New Drug Application for Vraylar (cariprazine), a previously approved drug for treating schizophrenia and bipolar disorder. Sage Therapeutics and Biogen also submitted a rolling NDA submission for zuranolone as a potential MDD treatment. Kv7 Advancement In addition to preparations for a Phase IIa trial of ETX-155, Eliem also announced plans to advance two candidates from its Kv7 program into IND-enabling studies. Filing of Investigational New Drug applications is expected in the first part of 2023. Eliem’s preclinical program targets the Kv7.2/3 potassium channel, creating potential targets for treating pain and epilepsy. Phase I studies of these programs are expected to begin in the first quarter of 2024. The company noted its Kv7 compounds have demonstrated high potency and differentiated selectivity in preclinical research. Fuller preclinical data on the Kv7 compounds are planned to be reported later in the fourth quarter of 2022. GAD Discontinuation and Opioid Setback While it advances its Kv7 program, Eliem announced it has discontinued early preclinical development of a non-sedating anxiolytic for the potential treatment of generalized anxiety disorder. The company reported none of the preclinical compounds it investigated achieved the required pro enable it to move toward the clinic. Mid-stage asset ETX-810, a non-opioid new entity, missed the mark in two separate studies this year. In April, the drug candidate failed to achieve endpoints in a Phase IIa study in diabetic peripheral neuropathic pain. As BioSpace previously reported , ETX-810 failed to outperform the placebo in its primary endpoint of improving daily pain. In August, ETX-810 failed to meet endpoints in a mid-stage study, this time as a potential treatment for lumbosacral radicular pain. Eliem reported that ETX-810 did not separate itself from placebo in a statistically significant manner. Based on the failures in both mid-stage studies, Eliem announced it was discontinuing the development of ETX-810. Going Forward “Both ETX-155 and Kv7 represent compelling product opportunities with the potential to be clinically differentiated drugs within classes where there is strong precedent clinical validation in depression and epilepsy, respectively,” said Bob Azelby, chief executive officer of Eliem, in a statement. Despite the recent setbacks, Azelby stated the company remains well capitalized to bring its programs through key clinical data catalysts. Eliem had $129.8 million in available cash and cash equivalents as of the end of September.

Initiated Phase 1 pharmacokinetic trial for ETX-155 with expected results in Q4 2022 Capital now expected to fund operations into 2025 SEATTLE and CAMBRIDGE, United Kingdom, Aug. 15, 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 psychiatry, epilepsy, chronic pain, and other disorders of the peripheral and central nervous systems, today provided a business update and reported financial results for the quarter ended June 30, 2022. “We continue to advance our pipeline targeting neuronal excitability disorders,” said Bob Azelby, president and chief executive officer of Eliem Therapeutics. “While we are disappointed with our recent announcement regarding the discontinuation of ETX-810, we continue to actively progress ETX-155. We have initiated our previously announced Phase 1 pharmacokinetic study of ETX-155 that is intended to confirm the dose that we will advance into a Phase 2a clinical trial in patients with major depressive disorder (MDD). We are encouraged by the precedent validation of the GABAA PAM class in multiple large depression trials and believe ETX-155 has the potential to be a clinically differentiated GABAA PAM product candidate.” 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 (PEA). On August 2, 2022, the Company reported that ETX-810 did not achieve statistically significant separation from placebo on the primary endpoint in the Phase 2a clinical trial investigating ETX-810 for the treatment of lumbosacral radicular pain. This result is consistent with the lack of separation from placebo observed in the Phase 2a clinical trial in diabetic peripheral neuropathic pain, as reported in April 2022. Therefore, the Company has discontinued further development of ETX-810. ETX-155 in depression and epilepsy: ETX-155 is a novel GABAA receptor positive allosteric modulator that the Company plans to evaluate in subjects with major depressive disorder (MDD) and epilepsy. In July 2022, the Company initiated a Phase 1 pharmacokinetic trial in healthy subjects using the drug batches that were used in the Phase 1b photosensitive epilepsy (PSE) trial. The objective of this Phase 1 trial is to identify the dose required to provide a similar exposure to that of the 60-milligram dose used in the previous 14-day repeat dose Phase 1 healthy volunteer trial. Results from the Phase 1 pharmacokinetic trial are expected in the fourth quarter of 2022. Once a dose level with appropriate exposure and safety is confirmed, the Company intends to initiate its previously planned randomized, placebo-controlled Phase 2a clinical trial in MDD patients. Assuming success in the Phase 1 pharmacokinetic trial in healthy subjects, the Company anticipates initiating this Phase 2a trial in MDD in the first quarter of 2023, and topline data would be expected in mid-2024. The Company will consider resuming the PSE trial after the expected readout of the Phase 1 pharmacokinetic trial in the fourth quarter of 2022. Kv7.2/3 channel opener program: The Company’s preclinical program targets the Kv7.2/3 potassium channel, a target that has clinical validation in pain and epilepsy. The Company has filed foundational intellectual property claims on its novel Kv7 development candidate and remains on track to initiate 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. Second Quarter 2022 Financial Results Cash Position: Cash, cash equivalents and short- and long-term marketable securities was $134.7 million as of June 30, 2022, as compared to $161.4 million as of December 31, 2021. With the discontinuation of ETX-810, the Company’s current cash, cash equivalents and short- and long-term marketable securities are now expected to fund operations into 2025.Research and Development (R&D) expenses: R&D expenses were $8.8 million for the three months ended June 30, 2022, compared to $5.8 million for the same period in 2021.General and Administrative (G&A) expenses: G&A expenses were $4.9 million for the three months ended June 30, 2022, compared to $2.9 million for the same period in 2021.Net loss: Net loss was $14.6 million for the three months ended June 30, 2022, compared to $8.7 million for the same period in 2021. The three months ended June 30, 2022 includes an unrealized foreign currency loss of $1.0 million primarily resulting from the effect of unfavorable exchange rates on the remeasurement of our British Pound denominated assets. 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 psychiatry, epilepsy, chronic pain, 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 advancement of Eliem’s pipeline; the continued development and clinical and therapeutic potential of ETX-155 and Eliem’s Kv7.2/3 channel opener program; Eliem’s plans for clinical trials of ETX-155 and the timing thereof; the progression of the Kv7.2/3 channel opener and next-generation anxiolytic preclinical programs, and Eliem’s plans with respect thereto; the expectation that Eliem’s current cash, cash equivalents and short- and long-term marketable securities will fund operations into 2025; and Eliem’s commitment to developing therapies targeting neuronal excitability disorders. Words such as “advance,” “anticipates,” “assuming,” “believe,” “continue,” “encouraged,” “expects,” “focus,” “intended,” “objective,” “on track,” “potential,” “progress,” “will,” “would,” 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-155 and Eliem’s preclinical programs; risks related to the potential failure of ETX-155 to demonstrate safety and efficacy in clinical testing; Eliem’s ability to initiate and conduct clinical trials and studies of 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 external events, including 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, 2022. 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. InvestorsChris Brinzey ICR Westwickechris.brinzey@westwicke.com339-970-2843 MediaMarites CoulterVerge ScientificMcoulter@vergescientific.com415.819.2214 Eliem Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts)(unaudited) Assets June 30, 2022 December 31, 2021 Current assets: Cash and cash equivalents $32,602 $46,922 Short-term marketable securities 90,349 89,558 Prepaid expenses and other current assets 10,125 11,772 Total current assets $133,076 $148,252 Operating lease right-of-use assets 697 — Long-term marketable securities 11,701 24,919 Other long-term assets 4,631 70 Total assets $150,105 $173,241 Liabilities and stockholders’ equity Current liabilities: Accounts payable 1,061 1,404 Accounts payable, related party 21 — Accrued expenses 6,072 4,588 Accrued expenses, related party 21 39 Operating lease liabilities, current 439 — Total current liabilities $7,614 $6,031 Other long-term liabilities — 7 Operating lease liabilities, net of current portion 256 — Total liabilities $7,870 $6,038 Stockholders’ equity Common stock, $0.0001 par value per share, 250,000,000 shares authorized; 26,567,681 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively 3 3 Additional paid-in capital 246,252 242,939 Accumulated other comprehensive loss (604) (123)Accumulated deficit (103,416) (75,616)Total stockholders’ equity $142,235 $167,203 Total liabilities and stockholders’ equity $150,105 $173,241 Eliem Therapeutics, Inc.Condensed Consolidated Statements of Operations(In thousands, except share and per share amounts)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Operating expenses: Research and development $8,740 $5,478 $16,851 $9,751 Research and development, related party 29 315 178 703 General and administrative 4,932 2,914 9,804 5,132 Total operating expenses 13,701 8,707 26,833 15,586 Loss from operations (13,701) (8,707) (26,833) (15,586)Other income (expense): Change in fair value of redeemable convertible preferred stock tranche liability — — — (11,718)Foreign currency loss (1,042) (12) (1,199) (16)Other income, net 147 — 232 — Total other income (expense) (895) (12) (967) (11,734)Net loss $(14,596) $(8,719) $(27,800) $(27,320)Accretion of redeemable convertible preferred stock to redemption value and cumulative preferred stock dividends — (2,141) — (3,226)Net loss attributable to common stockholders $(14,596) $(10,860) $(27,800) $(30,546)Net loss per share attributable to common stockholders, basic and diluted $(0.56) $(3.11) $(1.06) $(8.80)Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, basic and diluted 26,296,560 3,488,017 26,267,914 3,472,086