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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): March 15, 2022

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 March 15, 2022, Altimmune, Inc. (the “Company”) issued a press release announcing the Company’s financial results for its full year and fiscal quarter ended December 31, 2021. 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 March 15, 2022

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: March 15, 2022

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Exhibit 99.1

Altimmune Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update

Data readouts from multiple clinical trials expected during the next 6 to 12 months

Strong cash position of $190.3 million as of December 31, 2021

GAITHERSBURG, MD, -- March 15, 2022 -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.

“We expect the next 12 months to be a period of intense execution with value-creating data readouts from multiple clinical trials. We are extremely pleased with the progress of our pemvidutide (ALT-801) program as we showed double-digit weight loss after 12 weeks of treatment, good tolerability without the use of dose titration, and pronounced decreases in serum lipids commonly associated with cardiovascular disease. We also observed a remarkable reduction in liver fat content to undetectable levels after only 6 weeks of pemvidutide treatment in subjects with hepatic steatosis, or fatty liver,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. “In addition to our ongoing 12-week Phase 1b NAFLD trial, we expect to initiate a 48-week Phase 2 trial of pemvidutide in obesity, the MOMENTUM trial, in the next few weeks and look forward to sharing data from both of these trials later this year. In addition, we expect to read out our HepTcell trial in the first half of 2023.”

Recent Highlights and Anticipated Milestones:

Pemvidutide1 (ALT-801)

Enrollment in Phase 1b nonalcoholic fatty liver disease (NAFLD) trial is over 90% complete, and data readout is expected in Q3 2022

oThe 12-week trial is being conducted at 15 sites in the U.S., with Dr. Stephen A. Harrison serving as Principal Investigator. The trial will be comprised of 72 non-diabetic and diabetic subjects across four treatment arms (pemvidutide 1.2, 1.8, 2.4 mg and placebo).
oThe primary efficacy readouts of this trial are liver fat reduction and weight loss.
oA 52-week biopsy driven Phase 2 non-alcoholic steatohepatitis (NASH) trial is expected to follow the conclusion of the NAFLD trial.

Received U.S. Food and Drug Administration (FDA) clearance of pemvidutide investigational new drug application (IND) for obesity – Initiation of the Phase 2 MOMENTUM trial of pemvidutide in obesity expected in the first quarter of 2022

oThe trial is expected to enroll approximately 320 non-diabetic subjects with either obesity or overweight with at least one obesity-related complication. Subjects will be randomized

1 proposed INN


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1:1:1:1 to receive either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks.
oThe primary endpoint of the MOMENTUM trial is the relative (percent) change in body weight at 48 weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
oAn interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with an expected readout in Q4 2022.

Initiated a double-blind, placebo-controlled 12-week extension to the ongoing NAFLD Phase 1b Trial

oThis extension will allow subjects to receive up to a total of 24 weeks of pemvidutide or placebo and provide a read out on weight loss at 24 weeks.
oTopline data from the extension trial expected in Q4 2022.

Completed 6-month and 9-month toxicology studies of pemvidutide in rats and non-human primates

oNo significant findings, including no ALT or blood glucose elevations, were reported.
oToxicology results support 24-week NAFLD extension and 48-week obesity studies.

Initiated a 12-week Phase 1 trial to characterize effects of pemvidutide on glucose control in diabetic population
oThis represents a follow-on to the evaluation of a pre-diabetic population in our first-in-human trial in which reductions of insulin resistance and maintenance of glucose control were observed.

Results of a drug-drug interaction trial of pemvidutide expected in the first half of 2022

HepTcell

Enrollment ongoing for the Phase 2 clinical trial in chronic hepatitis B subjects, with study readout expected H1 2023
oReadouts from this trial are expected to include virological markers of hepatitis B infection and functional cure.

Financial Results for the Three Months Ended December 31, 2021

Altimmune had cash, cash equivalents, short-term investments and restricted cash totaling $190.3 million at December 31, 2021.
Revenue was $3.3 million for the three months ended December 31, 2021 compared to $2.3 million in the same period in 2020. The increase in revenue quarter over quarter was primarily due to the receipt of prior period rate adjustments under the Company’s U.S. government contract for NasoShield, partially offset by the discontinuation of development work under prior programs.


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Research and development expenses were $20.2 million for the three months ended December 31, 2021, compared to $9.0 million in the same period in 2020. The change was primarily the result of the increased costs related to the development of pemvidutide and an increase in the contingent liability for stock-based milestone payments associated with the acquisition of pemvidutide, partially offset by the discontinuation of development work for prior clinical programs.
General and administrative expenses were generally consistent period-over-period with $3.8 million recognized for the three months ended December 31, 2021 and $4.1 million in the same period in 2020.
Net loss for the three months ended December 31, 2021 was $23.9 million, or $0.57 net loss per share, compared to $10.6 million in the same period in 2020, or $0.29 net loss per share, due to the factors noted above.

Conference Call Information

Date:

Tuesday, March 15

Time:

8:30 am Eastern Time

Domestic Dial-in:

(844) 615-6509

International Dial-in:

(918) 922-3148

Conference ID:

4557398

Webcast:

https://edge.media-server.com/mmc/p/5www3cgz

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. By combining GLP-1 and glucagon activity in a single peptide, pemvidutide has the potential to achieve weight loss comparable to bariatric surgery. Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases its serum half-life for weekly dosing while slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability. In a 12-week Phase 1 clinical trial, pemvidutide-treated subjects demonstrated striking reductions in body weight, liver fat and serum lipids commonly associated with cardiovascular disease.

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.


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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 initiation and timing of the Phase 2 clinical trial of pemvidutide, the timing of the data readouts for the Phase 2 clinical trial 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: potential impacts due to crises, including conflicts and wars (like the ongoing conflict in Ukraine) and pandemics (like the COVID-19 pandemic), such as 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 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 annual report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC, which is available at www.sec.gov.

Investor & Media Contacts:

Rich Eisenstadt

Chief Financial Officer

Phone: 240-654-1450

reisenstadt@altimmune.com


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ALTIMMUNE, INC.

CONSOLIDATED BALANCE SHEETS

    

December 31, 

2021

2020

ASSETS

 

  

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

190,300,776

$

115,917,807

Restricted cash

 

34,174

 

34,174

Total cash, cash equivalents and restricted cash

 

190,334,950

 

115,951,981

Short-term investments

 

 

100,005,558

Accounts receivable

 

428,836

 

4,610,202

Income tax and R&D incentive receivables

 

5,409,639

 

7,762,793

Prepaid expenses and other current assets

 

7,952,690

 

1,926,675

Total current assets

 

204,126,115

 

230,257,209

Property and equipment, net

 

1,447,786

 

1,056,920

Intangible assets, net

 

12,418,967

 

12,823,846

Other assets

 

871,976

 

977,238

Total assets

$

218,864,844

$

245,115,213

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

2,034,493

$

612,293

Contingent consideration

6,090,000

Accrued expenses and other current liabilities

 

10,151,437

 

11,408,154

Total current liabilities

 

18,275,930

 

12,020,447

Contingent consideration

 

 

5,390,000

Other long-term liabilities

 

1,454,203

 

1,828,443

Total liabilities

 

19,730,133

 

19,238,890

Commitments and contingencies (Note 17)

 

  

 

  

Stockholders’ equity:

 

  

 

  

Common stock, $0.0001 par value; 200,000,000 shares authorized; 40,993,768 and 37,142,946 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively

4,090

3,697

Additional paid-in capital

 

497,342,207

 

417,337,742

Accumulated deficit

 

(293,171,423)

 

(186,420,599)

Accumulated other comprehensive loss, net

 

(5,040,163)

 

(5,044,517)

Total stockholders’ equity

 

199,134,711

 

225,876,323

Total liabilities and stockholders’ equity

$

218,864,844

$

245,115,213


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ALTIMMUNE, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Three Months Ended December 31,

Year Ended December 31,

2021

2020

2021

2020

Revenues

    

$

3,277,658

    

$

2,312,706

    

$

4,410,356

    

$

8,185,027

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

20,185,064

 

8,950,572

 

74,541,115

 

49,774,328

General and administrative

 

3,777,281

 

4,111,929

 

15,413,282

 

13,209,440

Impairment loss on construction-in-progress

 

3,300,000

 

 

11,370,000

 

Total operating expenses

 

27,262,345

 

13,062,501

 

101,324,397

 

62,983,768

Loss from operations

 

(23,984,687)

 

(10,749,795)

 

(96,914,041)

 

(54,798,741)

Other income (expense):

Interest expense

 

61,107

 

(1,953)

 

(5,656)

 

(9,421)

Interest income

 

114,894

 

44,360

 

202,741

 

322,514

Other (expense) income, net

 

(80,635)

 

(24,735)

 

(373,868)

 

24,147

Total other (expense) income, net

 

95,366

 

17,672

 

(176,783)

 

337,240

Net loss before income tax benefit

 

(23,889,321)

 

(10,732,123)

 

(97,090,824)

 

(54,461,501)

Income tax benefit

 

 

110,346

 

 

5,417,024

Net loss

$

(23,889,321)

$

(10,621,777)

$

(97,090,824)

$

(49,044,477)

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

 

 

(2,245)

 

4,354

 

(24,361)

Comprehensive loss

$

(23,889,321)

$

(10,624,022)

$

(97,086,470)

$

(48,017,632)

Net loss per share, basic and diluted

$

(0.57)

$

(0.29)

$

(2.35)

$

(1.91)

Weighted-average common shares outstanding, basic and diluted

 

41,705,563

 

36,295,023

 

41,283,498

 

25,637,023