Full Press Release Details
Second Quarter 2024 Financial Results and Highlights Recent Development and Corporate Achievements
- Initiated patient dosing in ESK-001
Phase 3 ONWARD clinical program in moderate-to-severe plaque psoriasis -
- Initiated Phase 1 clinical trial for
A-005 in healthy participants -
- Completed IPO and private placement
raising gross proceeds of $250M -
SOUTH SAN FRANCISCO, Calif., August 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 second quarter ended June 30, 2024, and provided a summary of
recent corporate achievements and upcoming milestones.
"We have made significant progress across our entire business,
achieving several critical development and corporate milestones to support our precision approach to replace broad immuno-suppression
with targeted therapies," said Martin Babler, President and Chief Executive Officer of Alumis. "Notably, we initiated a pivotal
Phase 3 clinical trial of ESK-001 in moderate-to-severe plaque psoriasis, advanced our second candidate, A-005, into the clinic for neuroinflammatory
and neurodegenerative diseases, and strengthened our balance sheet with a successful initial public offering. These achievements will
enable us to drive forward our mission to bring new, effective treatment options to patients living with immune-mediated diseases."
Babler added, "As we continue to
advance ESK-001 with the initiation of the ONWARD Phase 3 program, the ongoing LUMUS Phase 2b clinical trial for systemic lupus
erythematosus (SLE) and potentially additional indications in the future, we enter a new phase of growth as a late-stage development company
and look forward to several value-driving milestones anticipated over the next 12 to 18 months."
Second Quarter 2024 and Recent Corporate Highlights
Anticipated Milestones
Second 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 over the next twelve to eighteen months, 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, and expectations regarding the sufficiency 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 June 30, | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 48,565 | $ | 32,848 | $ | 90,526 | $ | 65,283 | ||||||||
| General and administrative expenses | 7,575 | 4,775 | 13,207 | 9,000 | ||||||||||||
| Total operating expenses | 56,140 | 37,623 | 103,733 | 74,283 | ||||||||||||
| Loss from operations | (56,140 | ) | (37,623 | ) | (103,733 | ) | (74,283 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1,977 | 913 | 2,831 | 1,558 | ||||||||||||
| Change in fair value of derivative liability | (2,311 | ) | 432 | (5,406 | ) | 432 | ||||||||||
| Other income (expenses), net | (34 | ) | (11 | ) | (49 | ) | (23 | ) | ||||||||
| Total other income (expense), net | (368 | ) | 1,334 | (2,624 | ) | 1,967 | ||||||||||
| Net loss | $ | (56,508 | ) | $ | (36,289 | ) | $ | (106,357 | ) | $ | (72,316 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on marketable securities, net | - | 30 | (3 | ) | 130 | |||||||||||
| Net loss and other comprehensive loss | $ | (56,508 | ) | $ | (36,259 | ) | $ | (106,360 | ) | $ | (72,186 | ) |
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 155,108 | $ | 45,996 | ||||
| Restricted cash | 113 | 113 | ||||||
| Marketable securities | 54,423 | 2,956 | ||||||
| Research and development prepaid expenses | 13,200 | 2,661 | ||||||
| Other prepaid expenses and current assets | 2,012 | 1,631 | ||||||
| Total current assets | 224,856 | 53,357 | ||||||
| Restricted cash, non-current | 1,024 | 1,024 | ||||||
| Property and equipment, net | 22,173 | 22,441 | ||||||
| Operating lease right-of-use assets, net | 12,772 | 12,783 | ||||||
| Other long-term assets | 4,354 | 7 | ||||||
| Total assets | $ | 265,179 | $ | 89,612 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 9,188 | $ | 1,118 | ||||
| Research and development accrued expenses | 14,584 | 10,946 | ||||||
| Other accrued expenses and current liabilities | 8,118 | 7,087 | ||||||
| Operating lease liabilities, current | 1,523 | 1,720 | ||||||
| Total current liabilities | 33,413 | 20,871 | ||||||
| Operating lease liabilities, non-current | 30,050 | 30,860 | ||||||
| Share repurchase liability | 1,234 | 1,771 | ||||||
| Total liabilities | 64,697 | 53,502 | ||||||
| Redeemable convertible preferred stock | 639,237 | 375,370 | ||||||
| Stockholders' deficit: | ||||||||
| Common stock | 1 | 1 | ||||||
| Additional paid-in capital | 31,920 | 25,055 | ||||||
| Accumulated other comprehensive (loss) income | (1 | ) | 2 | |||||
| Accumulated deficit | (470,675 | ) | (364,318 | ) | ||||
| Total stockholders' deficit | (438,755 | ) | (339,260 | ) | ||||
| Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $ | 265,179 | $ | 89,612 |
Alumis Contact Information
Red House Communications