Full Press Release Details
Reports Third Quarter 2024 Financial Results and Highlights Recent Achievements
- Presented data at EADV supporting potential
of ESK-001 as differentiated oral treatment in immune-mediated diseases through maximal TYK2 inhibition -
Continued to advance three clinical programs, including global Phase 3 ONWARD clinical trials for ESK-001 in moderate-to-severe plaque
psoriasis, Phase 2b clinical trial for ESK-001 in systemic lupus erythematosus (SLE) and Phase 1 clinical study for A-005
being developed for neuroinflammatory and neurodegenerative diseases -
FRANCISCO, Calif., November 13, 2024 - Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing
oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated
diseases, today reported financial results for the third quarter ended September 30, 2024, and highlighted recent achievements and
upcoming milestones.
"I am pleased with the important progress we've made across
our three clinical programs, as the team continues to show operational focus and execution, leveraging this momentum towards important
upcoming data readouts," said Martin Babler, President and Chief Executive Officer of Alumis. "ESK-001 and A-005 are designed
to be differentiated in the TYK2 space by achieving maximal TYK2 inhibition at doses with a favorable safety profile. With the potential
to combine high biologic-like efficacy with oral convenience, we are well positioned to deliver on the promise and impact that TYK2 inhibition
can have for patients with immune-mediated diseases."
Babler continued, "We look forward to continuing to generate
data with a goal of supporting best-in-class profiles for our programs, with A-005 Phase 1 data expected by year end and ESK-001 52-week
Phase 2 OLE study data expected in the first quarter of 2025."
Third Quarter 2024 Highlights
Anticipated Milestones
Third Quarter 2024 Financial Results
Alumis is a clinical-stage biopharmaceutical company developing oral
therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated
diseases. Leveraging its proprietary precision data analytics platform, Alumis is building a pipeline of molecules with the potential
to address a broad range of immune-mediated diseases as monotherapy or combination therapies. Alumis' most advanced product candidate,
ESK-001, is an oral, highly selective, small molecule, allosteric inhibitor of tyrosine kinase 2 that is currently being evaluated for
the treatment of patients with moderate-to-severe plaque psoriasis and systemic lupus erythematosus. Alumis is also developing A-005,
a CNS-penetrant, allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Beyond TYK2, Alumis'
proprietary precision data analytics platform and drug discovery expertise have led to the identification of additional preclinical programs
that exemplify its precision approach. Incubated by Foresite Labs and led by a team of industry veterans experienced in small-molecule
compound drug development for immune-mediated diseases, Alumis is pioneering a precision approach to drug development to potentially
produce the next generation of treatment to address immune dysfunction. For more information, visit www.alumis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may
be identified by words such as "aims," "anticipates," "believes," "could," "estimates,"
"expects," "forecasts," "goal," "intends," "may," "plans," "possible,"
"potential," "seeks," "will" and variations of these words or similar expressions that are intended to
identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed
to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding Alumis' future
plans and prospects, its anticipated milestones (including, without limitation, the expected timing of clinical trial results), its participation
at upcoming conferences, its ability to accomplish its mission to bring new, effective treatment options to patients living with immune-mediated
diseases, the success, cost and timing of its product candidate development activities and current and future clinical trials and studies,
including study design, any expectations regarding the safety, efficacy or tolerability of ESK-001, including based on the clinical update
from Alumis' Phase 2 STRIDE clinical trial and ongoing OLE study, the ability of ESK-001 to treat moderate-to-severe plaque psoriasis
or SLE, any expectations regarding the safety, efficacy or tolerability of A-005, and the ability of A-005 to treat MS and other neuroinflammatory
and neurodegenerative diseases, and expectations regarding the sufficiency and runway of capital resources. Any forward-looking statements
in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release
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. Readers are cautioned that actual results, levels of activity, safety, efficacy,
performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements
due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability
to advance ESK-001 and its other clinical candidates and to obtain regulatory approval of and ultimately commercialize Alumis'
clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities
and achieve development goals, Alumis' ability to protect its intellectual property and other risks and uncertainties described
in Alumis' filings with the Securities and Exchange Commission (SEC), including those described from time to time under the caption
"Risk Factors" and elsewhere in Alumis' current and future reports filed with the SEC, including its Quarterly Report
on Form 10-Q for the quarter ended June 30, 2024. Alumis explicitly disclaims any obligation to update any forward-looking
statements except to the extent required by law.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 87,824 | $ | 37,788 | $ | 178,350 | $ | 103,071 | ||||||||
| General and administrative expenses | 10,575 | 5,971 | 23,782 | 14,971 | ||||||||||||
| Total operating expenses | 98,399 | 43,759 | 202,132 | 118,042 | ||||||||||||
| Loss from operations | (98,399 | ) | (43,759 | ) | (202,132 | ) | (118,042 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 5,322 | 951 | 8,153 | 2,509 | ||||||||||||
| Change in fair value of derivative liability | - | (551 | ) | (5,406 | ) | (119 | ) | |||||||||
| Other income (expense), net | (40 | ) | (18 | ) | (89 | ) | (41 | ) | ||||||||
| Total other income (expense), net | 5,282 | 382 | 2,658 | 2,349 | ||||||||||||
| Net loss | $ | (93,117 | ) | $ | (43,377 | ) | $ | (199,474 | ) | $ | (115,693 | ) | ||||
| Other comprehensive income (loss) | ||||||||||||||||
| Unrealized gain (loss) on marketable securities, net | 140 | (3 | ) | 137 | 127 | |||||||||||
| Net loss and other comprehensive loss | $ | (92,977 | ) | $ | (43,380 | ) | $ | (199,337 | ) | $ | (115,566 | ) |
CONDENSED CONSOLIDATED
| September 30, | December 31, | |||||||
| (in thousands) | 2024 | 2023 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 213,417 | $ | 45,996 | ||||
| Restricted cash | - | 113 | ||||||
| Marketable securities | 148,453 | 2,956 | ||||||
| Research and development prepaid expenses | 12,241 | 2,661 | ||||||
| Other prepaid expenses and current assets | 3,236 | 1,631 | ||||||
| Total current assets | 377,347 | 53,357 | ||||||
| Restricted cash, non-current | 1,024 | 1,024 | ||||||
| Property and equipment, net | 21,429 | 22,441 | ||||||
| Operating lease right-of-use assets, net | 12,752 | 12,783 | ||||||
| Other long-term assets | 7 | 7 | ||||||
| Total assets | $ | 412,559 | $ | 89,612 | ||||
| Liabilities, Redeemable Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,444 | $ | 1,118 | ||||
| Research and development accrued expenses | 18,140 | 10,946 | ||||||
| Other accrued expenses and current liabilities | 7,464 | 7,087 | ||||||
| Operating lease liabilities, current | 1,467 | 1,720 | ||||||
| Total current liabilities | 33,515 | 20,871 | ||||||
| Operating lease liabilities, non-current | 29,631 | 30,860 | ||||||
| Share repurchase liability | 1,024 | 1,771 | ||||||
| Total liabilities | 64,170 | 53,502 | ||||||
| Redeemable convertible preferred stock | - | 375,370 | ||||||
| Stockholders' equity (deficit) | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 5 | 1 | ||||||
| Additional paid-in-capital | 912,037 | 25,055 | ||||||
| Accumulated other comprehensive income | 139 | 2 | ||||||
| Accumulated deficit | (563,792 | ) | (364,318 | ) | ||||
| Total stockholders' equity (deficit) | 348,389 | (339,260 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 412,559 | $ | 89,612 |
Alumis Contact Information
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