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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 28, 2023

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 28, 2023, Altimmune, Inc. (the “Company”) issued a press release announcing the Company’s financial results for its full year and fiscal quarter ended December 31, 2022. 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 9.01 Financial Statements and Exhibits

(d) Exhibits

No.

  

Description

99.1

  

Press Release of Altimmune, Inc. dated February 28, 2023

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/ Richard Eisenstadt

 

Name: Richard Eisenstadt

 

Title: Chief Financial Officer

Dated: February 28, 2023

Graphic

Exhibit 99.1

Altimmune Announces Fourth Quarter and Full Year 2022 Financial Results and Provides a Business Update

Interim 24-week readout from MOMENTUM Phase 2 obesity trial expected March 2023

Initiation of Phase 2b non-alcoholic steatohepatitis (NASH) trial expected mid-2023

Webcast to be held today, February 28, 2023, at 8:30 am ET

GAITHERSBURG, Maryland -- February 28, 2023 -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

“The next twelve-months is an important period for potential value-creating data readouts and the clinical development of pemvidutide, our GLP-1/glucagon dual-receptor agonist which is being developed for the treatment of both obesity and NASH. We are looking forward to announcing the top-line 24-week interim results from our MOMENTUM Phase 2 obesity trial in the second half of March,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “In addition, based on the compelling data from our recently completed trial in non-alcoholic fatty liver disease (NAFLD), which included greater than a 75% reduction in liver fat content and significant reductions in non-invasive markers of liver inflammation, we expect to initiate a Phase 2b biopsy-driven trial of pemvidutide in NASH in mid-2023. We expect the key endpoints of this trial to be NASH resolution and fibrosis improvement, both assessed following 24 weeks of treatment. Pemvidutide possesses key attributes that we expect to be important for both obesity and NASH, including the potential for robust reductions in body weight, liver fat, and liver inflammation, along with positive effects on serum lipids and blood pressure. We believe that the absence of dose titration further distinguishes pemvidutide from other incretin-based agents.”

Recent Highlights and Anticipated Milestones:

Pemvidutide

Positive top-line data readout from 24-week (12-week extension) Phase 1b NAFLD trial in December 2022
oGreater than a 75% relative reduction in liver fat content achieved, with over 50% of subjects achieving normalization of liver fat, at the 1.8 mg dose.
oSignificant reductions in serum alanine aminotransferase (ALT) and corrected T1 (cT1) observed, both established markers of liver inflammation, at the 1.8 mg dose.
oMean weight loss of 7.2% (placebo adjusted 6.0%) in subjects without diabetes, at the 1.8 mg dose.
oGlycemic control maintained with trends toward improvements in fasting glucose and HbA1c in subjects with type 2 diabetes.
oLow rates of treatment discontinuations due to adverse events.

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oClinically meaningful reductions in blood pressure with minimal increases in heart rate.

24-week interim analysis of approximately 160 subjects in MOMENTUM Phase 2 obesity trial expected in the second half of March 2023
oThis Phase 2 trial is being conducted at 30 sites across the U.S., with Dr. Lou Aronne, Professor of Clinical Medicine, Weill Cornell Medical College, a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator.
oThe trial was designed to enroll approximately 320 non-diabetic subjects with obesity, or overweight with at least one co-morbidity. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
oAt the 24-week interim analysis, the readout parameters are expected to include weight loss as measured by the relative (percent) change in body weight at 24 weeks compared to baseline, serum lipid profiles, adverse events, vital signs, glucose control and study discontinuations.
Initiation of Phase 2b NASH trial expected mid-2023
oThis Phase 2b biopsy-driven NASH trial will be conducted at approximately 60 sites in the U.S., with Dr. Stephen Harrison, Medical Director, Pinnacle Research, and Adjunct Professor of Medicine, Oxford University, who led our 12-week NAFLD trial and 12-week extension trials, serving as the principal investigator.
oThe key endpoints will be NASH resolution and fibrosis improvement after 24 weeks of treatment.
oThe trial is expected to commence mid-2023 with top-line results expected in the first half of 2025.

HepTcellTM

Enrollment in the Phase 2 clinical trial in chronic hepatitis B is over 90% complete
oThe trial was designed to enroll approximately 80 subjects with inactive chronic hepatitis B randomized 1:1 to HepTcell or placebo.
oKey endpoints include virological markers of hepatitis B infection.
oData readout is expected in the first half of 2024 after all subjects complete the 6-month course of treatment.

Patents

oOn January 3, 2023, the United States Patent and Trademark Office issued the patent “IMPROVED PEPTIDE PHARMACEUTICALS FOR TREATMENT OF NASH AND OTHER DISORDERS”, patent number 11,541,028, with an expiry of no earlier than January 3, 2039. The patent claims the use of pemvidutide for treating fatty liver diseases including NAFLD and NASH.


Graphic

Financial Results for the Three Months Ended December 31, 2022

Altimmune had cash, cash equivalents and short-term investments totaling $184.9 million at December 31, 2022.
Revenue was negligible for the three months ended December 31, 2022 compared to $3.3 million in the same period in 2021, as we are closing out the remaining government contracts due to the discontinuation of development activities for the T-COVID and NasoShield programs in 2021.
Research and development expenses were $19.2 million for the three months ended December 31, 2022, compared to $20.2 million in the same period in 2021. The expenses for the quarter ended December 31, 2022 included $13.4 million in direct costs related to development activities for pemvidutide and $1.9 million in direct costs related to development activities for HepTcell.
General and administrative expenses were consistent period-over-period at $3.8 million for each of the three months ended December 31, 2022 and 2021.
Net loss for the three months ended December 31, 2022 was $21.7 million, or $0.43 net loss per share, compared to a net loss of $23.9 million, or $0.57 net loss per share, in the same period in 2021.

Conference Call Information:

Date:

Tuesday, February 28, 2023

Time:

8:30 am 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, may register here to receive the dial-in numbers and unique PIN to access the call.

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations 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 NASH. 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, leading to rapid reductions in levels of liver fat. Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases its serum half-life for weekly dosing while likely slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability.


Graphic

About HepTcell

HepTcell is a novel, investigational, immunotherapeutic comprised of nine synthetic peptides representing conserved hepatitis B (HBV) sequences formulated with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.

About Altimmune

Altimmune is a clinical-stage biopharmaceutical company focused on the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell™, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. 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 relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the timing of the data readouts of the HepTcell trial and the Phase 2 obesity and NASH clinical trials of pemvidutide, and the prospects for 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. (the “Company”) 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 impact of liver fat content and demographics in the Phase 1b NAFLD study on the success of future trials; 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 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.


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Investor & Media Contacts:

Rich Eisenstadt

Chief Financial Officer

Phone: 240-654-1450

reisenstadt@altimmune.com


Graphic

ALTIMMUNE, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

    

December 31, 

2022

2021

ASSETS

 

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

111,097

$

190,301

Restricted cash

 

34

 

34

Total cash, cash equivalents and restricted cash

 

111,131

 

190,335

Short-term investments

 

73,783

 

Accounts receivable

 

173

 

429

Income tax and R&D incentive receivables

 

2,368

 

5,410

Prepaid expenses and other current assets

 

5,358

 

7,952

Total current assets

 

192,813

 

204,126

Property and equipment, net

 

1,081

 

1,448

Intangible assets, net

 

12,419

 

12,419

Other assets

 

615

 

872

Total assets

$

206,928

$

218,865

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

4,804

$

2,034

Contingent consideration

6,090

Accrued expenses and other current liabilities

 

12,250

 

10,152

Total current liabilities

 

17,054

 

18,276

Other long-term liabilities

 

4,581

 

1,454

Total liabilities

 

21,635

 

19,730

Commitments and contingencies (Note 17)

 

  

 

  

Stockholders’ equity:

 

  

 

  

Common stock, $0.0001 par value; 200,000,000 shares authorized; 49,199,845 and 40,993,768 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively

5

4

Additional paid-in capital

 

568,399

 

497,342

Accumulated deficit

 

(377,884)

 

(293,171)

Accumulated other comprehensive loss, net

 

(5,227)

 

(5,040)

Total stockholders’ equity

 

185,293

 

199,135

Total liabilities and stockholders’ equity

$

206,928

$

218,865


Graphic

ALTIMMUNE, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

Three Months Ended

Year Ended

December 31, 

December 31, 

2022

    

2021

    

2022

    

2021

Revenues

$

(110)

$

3,277

$

(68)

$

4,410

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

19,179

20,185

70,538

74,541

General and administrative

 

3,805

3,777

17,134

15,413

Impairment loss on construction-in-progress

 

3,300

11,370

Total operating expenses

 

22,984

27,262

87,672

101,324

Loss from operations

 

(23,094)

(23,985)

(87,740)

(96,914)

Other income (expense):

 

  

  

  

  

Interest expense

 

183

62

(8)

(5)

Interest income

 

1,468

115

2,870

203

Other income (expense), net

 

(217)

(81)

(32)

(374)

Total other income (expense), net

 

1,434

96

2,830

(176)

Net loss before income taxes

 

(21,660)

(23,889)

(84,910)

(97,090)

Income tax expense (benefit)

 

(197)

Net loss

 

(21,660)

(23,889)

(84,713)

(97,090)

Other comprehensive income — unrealized gain (loss) on short-term investments

 

76

(187)

4

Comprehensive loss

$

(21,584)

$

(23,889)

$

(84,900)

$

(97,086)

Net loss per share, basic and diluted

$

(0.43)

$

(0.57)

$

(1.81)

$

(2.35)

Weighted-average common shares outstanding, basic and diluted

 

50,026,686

41,705,563

46,926,349

41,283,498