0001326190false00013261902025-02-242025-02-24

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): February 24, 2025

ALTIMMUNE, INC.

(Exact name of registrant as specified in its charter)

Delaware

 

001-32587

 

20-2726770

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

910 Clopper Road, Suite 201S

Gaithersburg, Maryland

20878

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number including area code: (240) 654-1450

(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, par value $0.0001 per share

ALT

The NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company 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 

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 February 27, 2025, Altimmune, Inc. (the “Company”) issued a press release announcing the Company’s financial results for its fourth quarter and full yea ended December 31, 2024. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8 K.

The information included in this Current Report on Form 8 K (including Exhibit 99.1 hereto) that is furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. In addition, the information included in this Current Report on Form 8 K (including Exhibit 99.1 hereto) that is furnished pursuant to this Item 2.02 shall not be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference into such filing.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

On February 24, 2025, the Company’s Chief Medical Officer, Dr. Scott Harris, provided the Company advance notice of his intention to retire from Altimmune as of February 28, 2026. Dr. Harris will remain with the Company for the next year. The Company plans to initiate a search for Dr. Harris’ successor in the near future.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

No.

  

Description

99.1

Press Release of Altimmune, Inc. dated February 27, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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.

ALTIMMUNE, INC.

By:

 

/s/ Gregory Weaver

 

Name: Gregory Weaver

 

Title: Chief Financial Officer

Dated: February 27, 2025

Graphic

Exhibit 99.1

Altimmune Announces Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update

Top-line data from Phase 2b IMPACT trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) to be reported in Q2 2025

Investigational New Drug (IND) applications in two additional indications have received FDA clearance, with Phase 2 trials to commence mid-2025

Company to hold virtual R&D Day on March 13, 2025. Program will include KOL presentations on pemvidutide development in obesity, MASH and additional indications

Two pharmaceutical industry veterans added to Company Board of Directors

Cash, cash equivalents and short-term investments of $131.9 million on December 31, 2024

Webcast to be held today, February 27, 2025, at 8:30 a.m. ET

GAITHERSBURG, MD – February 27, 2025 – Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.

“2024 was a year of important progress for Altimmune as we continued to advance pemvidutide in multiple indications,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “As announced previously, we completed enrollment of the IMPACT Phase 2b trial of pemvidutide in MASH and are on track to report top-line data in the second quarter of 2025. IMPACT was one of the fastest enrolling biopsy-driven Phase 2b MASH trials, which we believe reflects the attractiveness of pemvidutide to patients and providers, specifically the compound’s potent reduction of both liver fat and body weight. Based on the totality of the data generated to date, including multiple non-invasive biomarkers of liver inflammation and fibrosis, we are confident that pemvidutide will achieve statistically significant improvements in biopsy endpoints, both MASH resolution and fibrosis improvement, at trial readout. We anticipate holding an end-of-Phase 2 meeting with FDA by the end of 2025 to gain alignment on the registrational Phase 3 program.”

Dr. Garg continued, “In-line with our previously stated plan, we submitted INDs for two additional indications in Q4 2024, and I am excited to report that both have received FDA clearance, and we are on track to initiate Phase 2 efficacy studies mid-2025. We look forward to providing information on these additional indications and our development plans during the upcoming virtual R&D Day on March 13. We believe that these indications reinforce our vision for the broad therapeutic utility of pemvidutide.”


Graphic

Recent Highlights and Anticipated Milestones

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

IMPACT, the Company’s biopsy-driven Phase 2b trial of pemvidutide in MASH, is on track for top-line data readout in Q2 2025
oIMPACT is evaluating the efficacy and safety of pemvidutide in approximately 190 subjects with biopsy-confirmed MASH.
oWith a successful readout from IMPACT, pemvidutide would be the first incretin to achieve statistical significance on MASH resolution and fibrosis improvement at only 24 weeks of treatment, and the first therapy in any class to achieve these endpoints along with meaningful weight loss at this timepoint.

Additional Indications for Pemvidutide

The Company submitted IND applications for pemvidutide in two additional indications at the end of 2024, both of which have been cleared by FDA.
oPhase 2 trials in additional indications are expected to initiate in mid-2025.

R&D Day – March 13, 2025

Altimmune will hold a virtual R&D Day on Thursday, March 13, 2025 at 12:00pm Eastern Time
oThe program will feature presentations on pemvidutide development from Company management and key opinion leaders in obesity, MASH and the two additional indications which will be disclosed during the event.
oDetails of the R&D Day, including registration information, are available at https://investorday.altimmune.com. Additional information related to the event will be posted to this site.

Corporate Update

The Company strengthened its Board of Directors with the appointments of pharmaceutical industry veterans Teri Lawver and Jerry Durso
oMs. Lawver has nearly 30 years of experience spanning pharmaceuticals, medical devices and consumer health technology. She most recently served as Executive Vice President and Chief Commercial Officer of Dexcom. Previously she served for over 20 years at Johnson & Johnson in various leadership roles, including as Global Vice President for the Cardiovascular & Metabolism therapeutic area and Worldwide Vice President for the Immunology business at Janssen Pharmaceuticals.
oMr. Durso brings more than 30 years of leadership experience in the life sciences industry, most recently serving as Chief Executive Officer at Intercept Pharmaceuticals where he built a successful rare liver disease franchise and ultimately led the Company through its acquisition by Alfasigma. Prior to Intercept, he spent over two decades in a variety of leadership roles at Sanofi, including Chief Commercial Officer for its U.S. Pharmaceuticals business.


Graphic

Financial Results for the Three Months Ended December 31, 2024

Altimmune reported cash, cash equivalents and short-term investments totaling $131.9 million on December 31, 2024.
Research and development expenses were $19.8 million for the three months ended December 31, 2024, compared to $16.9 million in the same period in 2023. The expenses for the quarter ended December 31, 2024, included $13.6 million in direct costs related to development activities for pemvidutide.
General and administrative expenses were $5.1 million for the three months ended December 31, 2024, compared to $4.3 million in the same period in 2023. The increase was primarily due to a $0.5 million increase in stock compensation.
Interest income was $1.6 million for the three months ended December 31, 2024, compared to $2.0 million for the same period in 2023.
Net loss for the three months ended December 31, 2024, was $23.2 million, or $0.33 net loss per share, compared to a net loss of $31.6 million, or $0.54 net loss per share, in the same period in 2023. The net loss for 2023 included the $12.4 million noncash impairment charge related to the discontinuation of development of HepTcell.

Financial Results for the Year Ended December 31, 2024

Research and development expenses were $82.2 million for the year ended December 31, 2024, compared to $65.8 million in the same period in 2023. The expenses for the year ended December 31, 2024, included $53.3 million in direct costs related to development activities for pemvidutide and $1.3 million in initial costs for additional research and discovery projects.
General and administrative expenses were $21.0 million for the year ended December 31, 2024, compared to $18.1 million in the same period in 2023. The increase was primarily due to a $2.7 million increase in stock compensation and other labor-related expenses, including the $1.0 million increase in stock compensation expense caused by modifications of stock awards.
Interest income was $8.1 million for the year ended December 31, 2024, compared to $7.4 million for the same period in 2023.
Net loss for the year ended December 31, 2024, was $95.1 million, or $1.34 net loss per share, compared to a net loss of $88.4 million, or $1.66 net loss per share, in the same period in 2023. The net loss for 2023 included the $12.4 million noncash impairment charge related to the discontinuation of development of HepTcell.

Conference Call Information:

Date:

February 27, 2025

Time:

8:30 a.m. Eastern Time

Webcast:

To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at https://ir.altimmune.com/investors.

Dial-in:

To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call.


Graphic

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss with class-leading lean mass preservation, and robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.

About Altimmune

Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity, MASH and other indications. For more information, please visit www.altimmune.com.

Follow @Altimmune, Inc. on LinkedIn
Follow @AltimmuneInc on Twitter

Forward-Looking Statement

Any statements made in this press release related to the development or commercialization of product candidates and other business matters, including without limitation, trial results and data, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions


Graphic

and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov.

Company Contact:

Gregory Weaver

Chief Financial Officer

Phone: 240-654-1450

ir@altimmune.com

Investor Contact:

Lee Roth

Burns McClellan

Phone: 646-382-3403

lroth@burnsmc.com

Media Contact:

Danielle Cantey

Inizio Evoke, Biotech

Phone: 619-826-4657

Danielle.cantey@inizioevoke.com


Graphic

ALTIMMUNE, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per-share amounts)

    

December 31, 

2024

2023

ASSETS

 

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

36,926

$

135,117

Restricted cash

 

42

 

41

Total cash, cash equivalents and restricted cash

 

36,968

 

135,158

Short-term investments

 

94,965

 

62,698

Accounts and other receivables

 

544

 

1,111

Income tax and R&D incentive receivables

 

2,573

 

3,742

Prepaid expenses and other current assets

 

2,204

 

6,917

Total current assets

 

137,254

 

209,626

Property and equipment, net

 

413

 

651

Other assets

 

1,639

 

363

Total assets

$

139,306

$

210,640

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

211

$

2,070

Accrued expenses and other current liabilities

 

10,257

 

10,073

Total current liabilities

 

10,468

 

12,143

Other noncurrent liabilities

 

5,330

 

4,398

Total liabilities

 

15,798

 

16,541

Commitments and contingencies

 

  

 

  

Stockholders’ equity:

 

  

 

  

Common stock, $0.0001 par value; 200,000,000 shares authorized; 72,352,701 and 70,677,400 shares issued and outstanding as of December 31, 2024 and 2023, respectively

7

7

Additional paid-in capital

 

689,864

 

665,427

Accumulated deficit

 

(561,390)

 

(466,331)

Accumulated other comprehensive loss, net

 

(4,973)

 

(5,004)

Total stockholders’ equity

 

123,508

 

194,099

Total liabilities and stockholders’ equity

$

139,306

$

210,640


Graphic

ALTIMMUNE, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per-share amounts)

Three Months Ended

Year Ended

December 31, 

December 31, 

2024

    

2023

    

2024

    

2023

Revenues

$

5

$

37

$

20

$

426

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

19,781

16,909

82,226

65,799

General and administrative

 

5,090

4,332

20,966

18,137

Impairment loss on intangible asset

 

12,419

12,419

Total operating expenses

 

24,871

33,660

103,192

96,355

Loss from operations

 

(24,866)

(33,623)

(103,172)

(95,929)

Other income (expense):

 

  

  

  

  

Interest expense

 

(1)

(2)

(9)

(35)

Interest income

 

1,569

1,964

8,074

7,351

Other income (expense), net

 

118

20

48

166

Total other income (expense), net

 

1,686

1,982

8,113

7,482

Net loss

 

(23,180)

(31,641)

(95,059)

(88,447)

Other comprehensive income — unrealized gain on short-term investments

 

(128)

120

31

223

Comprehensive loss

$

(23,308)

$

(31,521)

$

(95,028)

$

(88,224)

Net loss per share, basic and diluted

$

(0.33)

$

(0.54)

$

(1.34)

$

(1.66)

Weighted-average common shares outstanding, basic and diluted

 

71,260,875

58,442,779

71,003,399

53,246,937


v3.25.0.1
Document and Entity Information
Feb. 24, 2025
Cover [Abstract]  
Document Type 8-K
Document Period End Date Feb. 24, 2025
Entity File Number 001-32587
Entity Registrant Name ALTIMMUNE, INC.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 20-2726770
Entity Address State Or Province MD
Entity Address, Address Line One 910 Clopper Road
Entity Address, Adress Line Two Suite 201S
Entity Address, City or Town Gaithersburg
Entity Address, Postal Zip Code 20878
City Area Code 240
Local Phone Number 654-1450
Title of 12(b) Security Common stock, par value $0.0001 per share
Trading Symbol ALT
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001326190
Amendment Flag false
Pre-commencement Issuer Tender Offer false
Pre-commencement Tender Offer false
Soliciting Material false
Written Communications false
v3.25.0.1
Document Information
Feb. 24, 2025
Cover [Abstract]  
Document Type 8-K
Amendment false
CIK 0001326190
Registrant Name ALTIMMUNE, INC.
Period End Date Feb. 24, 2025

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