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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 13, 2024

 

 

 

Alumis Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-42143   86-1771129
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

280 East Grand Avenue

South San Francisco, California 94080

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (650) 231-6625

 

N/A

(Former name or former address, if changed since last report.)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading
Symbol(s)
  Name of each exchange
on which registered
Common Stock, $0.0001 par value per share   ALMS   The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 13, 2024, Alumis Inc. (the “Company”) issued a press release announcing, among other things, its financial results for the fiscal quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

 

All of the information furnished in this Item 2.02 and Exhibit 99.1 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press Release, dated August 13, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL Document).

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Alumis Inc.
     
  By: /s/ Martin Babler
    Martin Babler
    President and Chief Executive Officer and Director

 

Dated: August 13, 2024

 

 

 

Exhibit 99.1

 

 

Alumis Reports 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

 

Initiated patient dosing in the ONWARD Phase 3 clinical program in psoriasis: In July, Alumis announced the initiation of the ONWARD Phase 3 clinical program, which consists of two identical 24-week global Phase 3 clinical trials (ONWARD1 and ONWARD2) designed to evaluate the efficacy and safety of ESK-001, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, in adult patients with moderate-to-severe plaque psoriasis and also includes a long-term extension (LTE) trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The pivotal Phase 3 program is supported by positive Phase 2 clinical data from the STRIDE trial, as well as an ongoing open-label extension (OLE) study with data out to 28 weeks of treatment. Topline results are anticipated in 2026.

Initiated a Phase 1 clinical trial of A-005 in healthy participants: In April, Alumis announced that the first participant had been dosed in a Phase 1 clinical trial of A-005, a potential first-in-class, central nervous system (CNS) penetrant TYK2 inhibitor being developed for the treatment of neuroinflammatory and neurodegenerative diseases, with potential application in diseases such as multiple sclerosis and Parkinson’s Disease. The Phase 1 clinical trial is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple-ascending orally administered doses of A-005 in healthy volunteers, including confirmation of CNS penetration in humans.

Completed initial public offering: In July, Alumis completed its initial public offering (IPO) and a concurrent private placement, raising $250.0 million in aggregate gross proceeds before deducting underwriting discounts and commissions and other offering expenses. Alumis issued 15,625,000 shares of common stock at an offering price of $16.00 per share.

 

 

 

 

Anticipated Milestones

 

2024 

ESK-001 Phase 2 OLE data update in psoriasis (3Q 2024)

A-005: Phase 1 clinical trial data in healthy participants (by year-end 2024)

 

2025 

A-005: Initiation of Phase 2 clinical trial in multiple sclerosis (MS)

ESK-001: Phase 2 OLE 52-week data update in psoriasis

Third pipeline program: Investigational New Drug Application filing for third clinical candidate

 

2026 

ESK-001: Psoriasis Phase 3 topline data

ESK-001: SLE Phase 2b topline data

A-005: MS Phase 2 topline data

 

Second Quarter 2024 Financial Results

 

As of June 30, 2024, Alumis had cash and cash equivalents and marketable securities of $209.5 million, which, together with aggregate net proceeds from the closing of its IPO and concurrent private placement of $233.2 million, is expected to fund operations into 2026.

Research and development expenses were $48.6 million for the quarter ended June 30, 2024, compared to $32.8 million for the same period in 2023. The increase was primarily driven by an increase in contract manufacturing, preclinical, and clinical costs for the ESK-001 program and increased headcount in research and development teams to support development efforts.

General and administrative expenses were $7.6 million for the quarter ended June 30, 2024, compared to $4.8 million for the same period in 2023. The increase was primarily attributable to the expansion of administrative functions to support business operations and to prepare Alumis to operate as a public company.

Net loss was $56.5 million for the quarter ended June 30, 2024, compared to $36.3 million for the same period in 2023.

 

Upcoming Events

 

Alumis expects to participate in the following conferences:

oMorgan Stanley Global Healthcare Conference, September 5, 2024, New York, NY

oWells Fargo Healthcare Conference, September 6, 2024, Boston, MA

oBaird Global Healthcare Conference, September 11, 2024, New York, NY

oCantor Fitzgerald Global Healthcare Conference, September 17, 2024, New York, NY

oStifel Immunology and Inflammation Virtual Summit, September 18, 2024

o33rd Annual Congress for the European Academy of Dermatology & Venereology, September 25-28, 2024, Amsterdam, Netherlands

 

 

 

 

About Alumis

 

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.

 

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ALUMIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND

COMPREHENSIVE LOSS

(IN THOUSANDS)

(UNAUDITED)

 

   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)

 

 

 

 

ALUMIS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS)

(UNAUDITED)

 

   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

 

Teri Dahlman

Red House Communications

teri@redhousecomms.com