Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results

Ulixacaltamide (PRAX-944) Phase 2b Essential1 study topline results for essential tremor expected in 1Q23; Praxis to enter quiet period following market close on Thursday, February 9

Topline results expected for each of three clinical-stage epilepsy programs in 2023 – PRAX-222 first-in-patient EMBRAVE Study safety data mid-2023, PRAX-628 first-in-human Phase 1 data mid-2023, PRAX-562 Phase 2 EMBOLD Study results in 2H23

Cash and investments of $100.5 million as of December 31, 2022 supports runway into 1Q24

BOSTON, Feb. 07, 2023 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided a corporate update and reported financial results for the fourth quarter and full year 2022.

“This year is set up to be transformative for Praxis and for the patients that we serve, with topline results for the ulixacaltamide Essential1 study imminent and data expected from each of our four clinical-stage programs in 2023,” said Marcio Souza, president and chief executive officer of Praxis. “Based on our understanding of epilepsy genetics and unique capabilities to translate these insights into therapies for patients suffering from a broad range of CNS disorders, we have built two proprietary platforms, Cerebrum™ for small molecules and Solidus™ for antisense oligonucleotides, that we expect will drive continuous innovation and value creation this year and beyond.”

Recent Business Highlights and Upcoming Milestones:

Cerebrum™ Small Molecule Platform

Solidus™ Antisense Oligonucleotide (ASO) Platform

  • Praxis is conducting the first dose cohort (Part 1) of the PRAX-222 EMBRAVE study for the treatment of pediatric patients with early-onset SCN2A-DEE in the U.S. Following collection of the safety and efficacy data from the initial cohort of patients in the EMBRAVE study, the data will be evaluated and submitted to the FDA to support further dose escalation. Part 1 of the EMBRAVE study is a 21-week open label cohort, in which participants will receive PRAX-222 for up to 13 weeks, designed to determine the safety and tolerability of intrathecal delivery of PRAX-222. Topline results from Part 1 of the PRAX-222 EMBRAVE study are expected in mid-2023.
  • The Company remains on track to nominate a development candidate for its most advanced preclinical ASO program, PRAX-080 for the treatment of PCDH19, in the second half of 2023.

Fourth Quarter and Full Year 2022 Financial Results:

As of December 31, 2022, Praxis had $100.5 million in cash, cash equivalents and marketable securities, compared to $275.9 million in cash, cash equivalents and marketable securities as of December 31, 2021. This decrease of $175.4 million primarily reflects cash used in operations of $185.0 million during the year ended December 31, 2022, partially offset by $9.6 million in net proceeds from at-the-market offerings of shares of the Company’s common stock. The Company’s cash, cash equivalents and marketable securities as of December 31, 2022 are expected to fund operations into the first quarter of 2024.

Research and development expenses were $28.3 million for the fourth quarter of 2022, compared to $43.5 million for the fourth quarter of 2021. Research and development expenses were $155.0 million for the year ended December 31, 2022, compared to $120.3 million for the year ended December 31, 2021. The increase in research and development expenses for full year 2022 of $34.7 million was primarily attributable to $29.9 million in increased expenses related to the Company’s Cerebrum™ and Solidus™ platforms.

General and administrative expenses were $13.1 million for the fourth quarter of 2022, compared to $15.1 million for the fourth quarter of 2021. General and administrative expenses were $59.9 million for the year ended December 31, 2022, compared to $47.1 million for the year ended December 31, 2021. The increase in general and administrative expenses for full year 2022 of $12.8 million was primarily attributable to an increase of $11.8 million in personnel-related expenses due to changes in headcount, including an increase of $5.3 million in stock-based compensation expense.

Praxis reported a net loss of $41.2 million for the fourth quarter of 2022, including $6.4 million of stock-based compensation expense, compared to $58.6 million for the fourth quarter of 2021, including $6.1 million of stock-based compensation expense. Praxis reported a net loss of $214.0 million for the year ended December 31, 2022, including $28.6 million of stock-based compensation expense, compared to a net loss of $167.1 million for the year ended December 31, 2021, including $22.7 million of stock-based compensation expense.

As of December 31, 2022, Praxis had 49.4 million shares of common stock outstanding.

About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Praxis’ future expectations, plans and prospects, including, without limitation, statements regarding expectations, plans and timing for our clinical data, the anticipated timing of our clinical trials and regulatory interactions, the development of our product candidates, including the design of our clinical trials and the treatment potential of our product candidates, and the sufficiency of our cash, cash equivalents and marketable securities, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “endeavor,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would” and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995.

The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials; the expected timing of submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials; Praxis’ ability to continue as a going concern; and other risks concerning Praxis’ programs and operations as described in its Annual Report on Form 10-K for the year ended December 31, 2022 to be filed and other filings made with the Securities and Exchange Commission. Although Praxis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on information and factors currently known by Praxis. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

PRAXIS PRECISION MEDICINES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)

  December 31,
    2022       2021  
Assets  
Cash and cash equivalents $ 61,615     $ 138,704  
Marketable securities   38,874       137,207  
Prepaid expenses and other current assets   10,351       11,498  
Property and equipment, net   971       1,213  
Operating lease right-of-use assets   2,901       3,653  
Other non-current assets   416       472  
Total assets $ 115,128     $ 292,747  
Liabilities and stockholders’ equity    
Accounts payable $ 14,672     $ 10,780  
Accrued expenses   15,850       26,844  
Operating lease liabilities   3,500       4,311  
Deferred revenue   5,000        
Common stock   5       5  
Additional paid-in capital   606,918       567,598  
Accumulated other comprehensive loss   (173 )     (176 )
Accumulated deficit   (530,644 )     (316,615 )
Total liabilities and stockholders’ equity $ 115,128     $ 292,747  
               


PRAXIS PRECISION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
(Amounts in thousands, except share and per share amounts)
(Unaudited)

  Three Months Ended
December 31,
  Year Ended
December 31,
    2022       2021       2022       2021  
Operating expenses:              
Research and development $ 28,329     $ 43,511     $ 155,040     $ 120,257  
General and administrative   13,124       15,146       59,946       47,075  
Total operating expenses   41,453       58,657       214,986       167,332  
Loss from operations   (41,453 )     (58,657 )     (214,986 )     (167,332 )
Other income:              
Other income, net   280       70       957       271  
Total other income   280       70       957       271  
Loss before benefit from income taxes   (41,173 )     (58,587 )     (214,029 )     (167,061 )
Benefit from income taxes         5              
Net loss $ (41,173 )   $ (58,582 )   $ (214,029 )   $ (167,061 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.87 )   $ (1.30 )   $ (4.64 )   $ (3.94 )
Weighted average common shares outstanding, basic and diluted   47,594,823       44,964,580       46,096,737       42,454,055  


1mADL is a composite sum of items 1 to 11 of the TETRAS-ADL subscale and items 6 (bilateral) and 7 of the TETRAS-PS; mADL score is calculated as the sum of all 13 items (item 6 of TETRAS-PS x2) and ranges from 0 to 42

CONTACT: Investor Contact
Alex Kane
Praxis Precision Medicines
investors@praxismedicines.com
617-300-8481

Media Contact
Ian Stone
Canale Communications
Ian.stone@canalecomm.com
619-849-5388

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