UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
| |||
(State or other jurisdiction of incorporation) |
| (Commission File Number) |
| (IRS Employer Identification No.) |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number including area code: (
(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 |
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 November 7, 2023, Altimmune, Inc. (the “Company”) issued a press release announcing the Company’s financial results for its fiscal quarter ended September 30, 2023. 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 |
| |
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: November 7, 2023
Exhibit 99.1
Altimmune Announces Third Quarter 2023 Financial Results and Provides a Business Update
Top-line 48-week results from the MOMENTUM Phase 2 obesity trial expected Q4 2023
Pemvidutide granted Fast Track designation for the treatment of non-alcoholic steatohepatitis (NASH)
Top-line results from the Phase 2 trial of HepTcellTM in chronic hepatitis B (CHB) expected Q1 2024
Webcast to be held today, November 7, 2023, at 8:30 am EST
GAITHERSBURG, Maryland – November 7, 2023 – Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three months ended September 30, 2023, and provided a business update.
“The next few months will be important as we receive the data from our 48-week MOMENTUM trial of pemvidutide in subjects with obesity as well as the results of our Phase 2 trial of HepTcell in CHB,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “The rapidly expanding obesity market needs differentiated products that address not only excess body weight, but also risk factors for cardiovascular comorbidities, including elevated LDL-cholesterol and excess liver fat. We also were very pleased to receive Fast Track designation for our pemvidutide program in NASH, which demonstrates the unmet need for this critical liver disease. We believe that our liver fat reduction is class-leading and could result in unprecedented reductions of fibrosis and measures of NASH.”
Recent Highlights and Anticipated Milestones
Pemvidutide
| ● | Top-line data readout from 48-week MOMENTUM Phase 2 obesity trial expected in Q4 2023 |
| o | Patient dosing (last subject last dose) was completed in September 2023. |
| o | Dr. Louis Aronne, Professor of Metabolic Research and Professor of Clinical Medicine, Weil Cornell Medical School, a leading authority in obesity and obesity clinical trials, is serving as the Principal Investigator. |
| o | 391 subjects with obesity or overweight and without diabetes 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. |
| o | In an interim 24-week data readout in March 2023, subjects receiving pemvidutide achieved robust reductions in body weight, waist circumference, serum lipids and blood pressure without arrhythmias, clinically meaningful heart rate increases or other safety signals. |
| o | Top-line data readout at 48 weeks will include subject disposition, weight loss, serum lipids, vital signs, adverse events and glycemic control. |
| ● | Enrollment commenced in IMPACT Phase 2b NASH trial |
| o | Informed by the positive results of the Phase 1b randomized, placebo-controlled trials of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD), the FDA granted pemvidutide Fast Track designation for the treatment of NASH. |
| o | Approximately 190 subjects with and without diabetes are planned to be randomized 1:2:2 to 1.2 mg, 1.8 mg pemvidutide or placebo. |
| o | The key endpoints will be NASH resolution and fibrosis improvement after 24 weeks of treatment, with subjects followed for an additional 24 weeks for assessment of safety and additional biomarker responses. |
| o | Top-line results after 24 weeks of treatment are expected in the first quarter of 2025. |
HepTcellTM
| ● | Top-line data from Phase 2 clinical trial expected in Q1 2024 |
| o | The multicenter clinical trial, which is being conducted at 26 sites in North America, Europe and Southeast Asia, enrolled approximately 80 previously untreated subjects with inactive CHB and low levels of hepatitis B surface antigen (HBsAg). |
| o | Subjects were randomized 1:1 to HepTcell or placebo to receive six monthly administrations. |
| o | The primary endpoint is virological response, defined as a 1-log or greater reduction or clearance of HBsAg; secondary endpoints include changes in the levels of hepatitis B virus (HBV) DNA, pre-genomic RNA and other markers of virologic response. |
| o | Data readout is expected in the first quarter of 2024 after all subjects complete the 6-month course of treatment. |
Financial Results for the Three Months Ended September 30, 2023
| ● | Cash, cash equivalents and short-term investments totaled $140.8 million as of September 30, 2023. |
| ● | Research and development expenses were $18.4 million for the three months ended September 30, 2023, compared to $20.3 million in the same period in 2022. The expenses for the quarter ended September 30, 2023 included $10.4 million in direct costs related to development activities for pemvidutide and $1.6 million in direct costs related to development activities for HepTcell. |
| ● | General and administrative expenses were consistent period-over-period at $4.5 million for the three months ended September 30, 2023 and 2022. |
| ● | Interest income for the three months ended September 30, 2023 was $1.9 million as compared to $1.1 million in the same period in 2022, primarily due to an increase in interest income earned on cash equivalents and short-term investments. |
| ● | Net loss for the three months ended September 30, 2023 was $20.7 million, or $0.39 net loss per share, compared to a net loss of $23.5 million, or $0.48 net loss per share, in the same period in 2022. |
Conference Call Information:
Date: | Tuesday, November 7, 2023 |
Time: | 8:30 am EST |
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. |
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.
About HepTcell
HepTcell is a novel, investigational, immunotherapeutic comprised of nine synthetic peptides representing conserved T-cell epitopes on key HBV antigens 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 developing innovative next-generation therapeutics for the treatment of patients with liver diseases and obesity. 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 HepTcellTM, an immunotherapeutic designed to achieve a functional cure for CHB. 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, 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 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.
Investor Contact:
Rich Eisenstadt |
Chief Financial Officer |
Phone: 240-654-1450 |
reisenstadt@altimmune.com |
Media Contact:
Danielle Cantey |
Evoke Canale |
Phone: 619-826-4657 |
danielle.cantey@evokegroup.com |
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per-share amounts)
|
| September 30, | | December 31, | ||
| | 2023 | | 2022 | ||
| | (Unaudited) | | | | |
ASSETS |
| | |
| |
|
Current assets: |
| |
|
| |
|
Cash and cash equivalents | | $ | 86,855 | | $ | 111,097 |
Restricted cash | |
| 41 | |
| 34 |
Total cash, cash equivalents and restricted cash | |
| 86,896 | |
| 111,131 |
Short-term investments | |
| 53,924 | |
| 73,783 |
Accounts receivable | |
| 876 | |
| 173 |
Income tax and R&D incentive receivables | |
| 3,653 | |
| 2,368 |
Prepaid expenses and other current assets | |
| 7,615 | |
| 5,358 |
Total current assets | |
| 152,964 | |
| 192,813 |
Property and equipment, net | |
| 765 | |
| 1,081 |
Indefinite-lived intangible asset | |
| 12,419 | |
| 12,419 |
Other assets | |
| 425 | |
| 615 |
Total assets | | $ | 166,573 | | $ | 206,928 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
|
| |
|
|
Current liabilities: | |
|
| |
|
|
Accounts payable | | $ | 3,046 | | $ | 4,804 |
Accrued expenses and other current liabilities | |
| 8,825 | |
| 12,250 |
Total current liabilities | |
| 11,871 | |
| 17,054 |
Other long-term liabilities | |
| 4,305 | |
| 4,581 |
Total liabilities | |
| 16,176 | |
| 21,635 |
Commitments and contingencies (Note 10) | |
|
| |
|
|
Stockholders’ equity: | |
|
| |
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized; 52,858,920 and 49,199,845 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | | | 5 | | | 5 |
Additional paid-in capital | |
| 590,206 | |
| 568,399 |
Accumulated deficit | |
| (434,690) | |
| (377,884) |
Accumulated other comprehensive loss, net | |
| (5,124) | |
| (5,227) |
Total stockholders’ equity | |
| 150,397 | |
| 185,293 |
Total liabilities and stockholders’ equity | | $ | 166,573 | | $ | 206,928 |
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per-share amounts)
| | Three Months Ended | | Nine Months Ended | ||||||||
| | September 30, | | September 30, | ||||||||
| | 2023 |
| 2022 |
| 2023 |
| 2022 | ||||
Revenues | | $ | 362 | | $ | 2 | | $ | 389 | | $ | 42 |
Operating expenses: | |
|
| |
|
| |
|
| |
|
|
Research and development | |
| 18,388 | | | 20,262 | | | 48,890 | | | 51,359 |
General and administrative | |
| 4,514 | | | 4,492 | | | 13,805 | | | 13,329 |
Total operating expenses | |
| 22,902 | | | 24,754 | | | 62,695 | | | 64,688 |
Loss from operations | |
| (22,540) | | | (24,752) | | | (62,306) | | | (64,646) |
Other income (expense): | |
|
| | |
| | |
| | |
|
Interest expense | |
| (29) | | | (64) | | | (33) | | | (191) |
Interest income | |
| 1,884 | | | 1,053 | | | 5,387 | | | 1,402 |
Other income (expense), net | |
| 14 | | | 50 | | | 146 | | | 185 |
Total other income (expense), net | |
| 1,869 | | | 1,039 | | | 5,500 | | | 1,396 |
Net loss before income taxes | |
| (20,671) | | | (23,713) | | | (56,806) | | | (63,250) |
Income tax expense (benefit) | |
| — | | | (197) | | | — | | | (197) |
Net loss | |
| (20,671) | | | (23,516) | | | (56,806) | | | (63,053) |
Other comprehensive income — unrealized gain (loss) on short-term investments | |
| 56 | | | (143) | | | 103 | | | (263) |
Comprehensive loss | | $ | (20,615) | | $ | (23,659) | | $ | (56,703) | | $ | (63,316) |
Net loss per share, basic and diluted | | $ | (0.39) | | $ | (0.48) | | $ | (1.10) | | $ | (1.37) |
Weighted-average common shares outstanding, basic and diluted | |
| 53,633,354 | | | 49,286,535 | | | 51,495,957 | | | 45,881,547 |