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): May 14, 2019
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) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2).
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 May 14, 2019, Altimmune, Inc. (the “ Company ”) issued a press release announcing the Company’s financial results for its fiscal quarter ended March 31, 2019. 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 |
|
|
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/ Will Brown_______________ |
|
|
|
Name: Will Brown |
|
|
|
Title: Acting Chief Financial Officer |
Dated May 14, 2019
Exhibit 99.1
Altimmune Announces First Quarter 2019 Financial Results and Provides a Business Update
Conference Call & Webcast Scheduled for Wednesday, May 15, at 8:30am Eastern Time
GAITHERSBURG, Maryland, May 14, 2019 – Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced financial results for the first quarter ended March 31, 2019 and provided a business update.
"We made great progress in the first quarter, as we executed on our strategy and worked to build long-term shareholder value," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. “We are diligently exploring opportunities to expand our pipeline via acquisition and in-licensing opportunities in both immuno-oncology and liver disease indications. We continue to advance the development of our current key assets, HepTCell and ALT-702, and anticipate achieving significant milestones in both these programs during the next 12 to 18 months. In addition, we have made important advances in both our NasoVAX and NasoShield programs.”
Recent Highlights
|
• |
HepTcell Phase 1 Clinical Trial Data Presented at International Liver Congress |
The Company presented results of its HepTcell Phase 1 clinical trial at The International Liver CongressTM sponsored by The European Association for the Study of the Liver (EASL). Mark Thursz, MBBS, MD, FRCP, Professor of Hepatology at Imperial College, London, presented HepTcell Phase 1 data in the session entitled “Hepatitis B – Drug Development.” As previously announced, the successful clinical trial met its primary endpoint of safety and showed that HepTcell treatment was associated with increased HBV-specific cellular immune responses. The Company is preparing to initiate a Phase 2 clinical study in the U.S. in 2020.
|
• |
ALT-702 Preclinical Development Initiated |
Recently initiated preclinical development of its immunostimulant product candidate, ALT-702. ALT-702 is based on a new synthetic peptide conjugate technology platform that allows localized immune stimulation without the safety risk of systemic inflammation. ALT-702 represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses and other approaches in immuno-oncology. The Company expects to provide an update on the progress of ALT-702 later this year.
|
• |
NasoVAX Phase 2 Extension Study Completed Showing Durable Immune Response |
The Company presented results of its NasoVAX Phase 2 study and the recently completed extension study at the World Vaccine Congress. As previously announced, the Phase 2 data showed that NasoVAX was well-tolerated and highly immunogenic, demonstrating 100% seroprotection at two of the three dose levels studied. Data from the extension study showed that the immunogenic responses were durable with 100% of the evaluated subjects remaining seroprotected with no decrease in seroconversion rate more than one year after vaccination. Durable responses on the order of one year are not expected from current injected influenza vaccines and suggest that the immune response induced by NasoVAX could be protective for the duration of a long flu season. The Company is actively looking for a strategic partner to further develop and commercialize NasoVAX.
|
• |
NasoShield Investigation Completed with Potential Path Forward in the Clinic |
Completed the investigations of potential causes that may have contributed to the lower than expected immune response in the Phase I study of NasoShield funded through a contract (HHSO100201600008C) with the Biomedical Advanced Research and Development Authority (“BARDA”). The results of these investigations are very encouraging and clearly show that while the vaccine product used in the clinical study continues to meet all manufacturing standards, the immune response to NasoShield is strongly affected by the intranasal administration method. Based on these findings, the Company believes that a simple adjustment to the intranasal dosing procedure may allow NasoShield to elicit a full immune response in humans.
|
• |
Completed Registered Direct Offering Raising Gross Proceeds of $14 Million |
Completed a Registered Direct Offering in March 2019 that raised gross proceeds of $14 million, which brings total gross proceeds received from equity offerings since September 2018 to $56 million. These financings provide the Company with the necessary resources to further develop its programs and position itself for potential acquisitions.
Financial Results for the First Quarter Ended March 31, 2019
|
• |
The Company had cash, restricted cash and cash equivalents of $44.9 million at March 31, 2019. This was an increase of $10.6 million since the prior year end due to the receipt of net proceeds of $12.7 million through the Registered Direct Offering offset by operating cash burn of $2.1 million. |
|
• |
Revenue in the first quarter was $2.96 million compared to $2.69 million in the prior year period. The increase was due primarily to billings under the Company’s NasoShield contract with BARDA. |
|
• |
Research and development expenses in the first quarter were $3.22 million compared to $5.75 million in the prior year period. The decrease was primarily attributable to lower spending on its NasoVAX and HepTcell programs. |
|
• |
Net loss attributed to common stockholders for the first quarter was $2.55 million, or ($0.27) per share, compared to $5.06 million, or ($7.49) per share in the same period of 2018. |
|
Conference Call Details |
||
|
Date: |
|
Wednesday, May 15, 2019 |
|
Time: |
|
8:30am Eastern Time |
|
Domestic: |
|
877-423-9813 |
|
International: |
|
201-689-8573 |
|
Conference ID: |
|
13690295 |
|
Webcast: |
|
http://public.viavid.com/index.php?id=134334 |
About Altimmune
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease. HepTcell is a synthetic peptide immunotherapeutic candidate designed to break immune tolerance in chronic Hepatitis B infection. ALT-702, a TLR7/8 agonist conjugate, is a tumor immunostimulant product candidate that has the potential to safely elicit or improve immune responses in a variety of cancer indications. NasoVAX, our influenza vaccine candidate, has unique characteristics that stimulate multiple arms of the immune system and offers the potential to stop infection and the spread of flu, while being easier to administer through an intranasal rout. NasoShield is a next-generation intranasal anthrax vaccine candidate that is designed to provide more rapid and stable protection than the only approved anthrax vaccine. By leveraging the complementary attributes of its proprietary technology platforms, Altimmune is able to design and develop immunotherapeutic products tailored to address a wide range of disease indications including both acute and chronic infections and cancer. For more information on Altimmune, please visit the website www.altimmune.com.
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, our ability to expand our product pipeline via acquisition or licensing opportunities, the timing of key milestones for our clinical assets, the initiation of a HepTcell Phase 2 clinical study in the U.S. in 2020, the prospects for 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: the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; funding delays, reductions in or elimination of U.S. government funding and/or non-renewal of expiring funding under the Company’s agreement with Biomedical Advanced Research and Development Authority (“BARDA”), or the Company’s contract with the National Institutes of Allergy and Infectious Diseases (“NIAID”); the Company’s ability to satisfy certain technical milestones under the Company’s contracts with BARDA and NIAID that would entitle the Company to receive additional funding over the period of the agreement; the preservation of the Company’s net operating loss carryforwards; the impact of the Tax Cuts and Jobs Act; delays caused by third parties challenging government contracts awarded to the Company; the receipt of future potential payments under government contracts or grants; the Company’s ability to identify potential future government contracts or grant awards; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated, or at all; the Company’s ability to obtain additional patents or extend existing patents on the timelines anticipated, or at all; the Company’s ability to identify and consummate potential future strategic partnerships or business combinations; the Company’s ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Company’s ability to commercialize its products; the Company’s anticipated financial or operational results; the Company’s ability to obtain additional capital resources; unforeseen safety and efficacy issues; breaches of data privacy, or disruptions in the Company’s information technology systems; and the Company’s ability to continue to satisfy the listing requirements of the NASDAQ Global Market. 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 reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, which are available at www.sec.gov.
|
Contacts |
|
|
|
|
Ashley R. Robinson |
|
|
President and CEO |
|
Managing Director LifeSci Advisors |
|
Phone: 240-654-1450 |
|
Phone: 617-535-7742 |
|
Email: vgarg@altimmune.com |
|
Email: arr@lifesciadvisors.com |
CONSOLIDATED BALANCE SHEETS
|
|
|
March 31, 2019 |
|
|
December 31, 2018 |
|
||
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
44,300,170 |
|
|
$ |
33,718,713 |
|
|
Restricted cash |
|
|
634,934 |
|
|
|
634,416 |
|
|
Total cash, cash equivalents and restricted cash |
|
|
44,935,104 |
|
|
|
34,353,129 |
|
|
Accounts receivable |
|
|
2,906,130 |
|
|
|
3,461,938 |
|
|
Tax refund receivable |
|
|
1,066,869 |
|
|
|
1,008,973 |
|
|
Prepaid expenses and other current assets |
|
|
505,949 |
|
|
|
548,094 |
|
|
Total current assets |
|
|
49,414,052 |
|
|
|
39,372,134 |
|
|
Property and equipment, net |
|
|
1,282,752 |
|
|
|
1,342,802 |
|
|
Right of use asset |
|
|
744,929 |
|
|
|
— |
|
|
Intangible assets, net |
|
|
13,762,199 |
|
|
|
13,851,924 |
|
|
Other assets |
|
|
169,898 |
|
|
|
183,682 |
|
|
Total assets |
|
$ |
65,373,830 |
|
|
$ |
54,750,542 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
227,117 |
|
|
$ |
71,596 |
|
|
Accounts payable |
|
|
14,753 |
|
|
|
372,860 |
|
|
Accrued expenses and other current liabilities |
|
|
3,434,519 |
|
|
|
4,082,949 |
|
|
Total current liabilities |
|
|
3,676,389 |
|
|
|
4,527,405 |
|
|
Deferred income taxes |
|
|
58,500 |
|
|
|
58,500 |
|
|
Other long-term liabilities |
|
|
2,316,831 |
|
|
|
1,852,071 |
|
|
Total liabilities |
|
|
6,051,720 |
|
|
|
6,437,976 |
|
|
Commitments and contingencies (Note 11) |
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized; 13,451,105 and 9,078,735 shares issued; 13,450,680 and 9,078,238 shares outstanding at March 31, 2019 and December 31, 2018, respectively |
|
|
1,313 |
|
|
|
876 |
|
|
Additional paid-in capital |
|
|
183,314,257 |
|
|
|
170,207,844 |
|
|
Accumulated deficit |
|
|
(118,953,297 |
) |
|
|
(116,855,991 |
) |
|
Accumulated other comprehensive loss – foreign currency translation adjustments |
|
|
(5,040,163 |
) |
|
|
(5,040,163 |
) |
|
Total stockholders’ equity |
|
|
59,322,110 |
|
|
|
48,312,566 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
65,373,830 |
|
|
$ |
54,750,542 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2019 |
|
|
2018 |
|
|||
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
2,955,592 |
|
|
$ |
2,690,980 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,217,671 |
|
|
|
5,746,971 |
|
|
General and administrative |
|
|
2,066,482 |
|
|
|
2,447,894 |
|
|
Impairment charges |
|
|
— |
|
|
|
490,676 |
|
|
Total operating expenses |
|
|
5,284,153 |
|
|
|
8,685,541 |
|
|
Loss from operations |
|
|
(2,328,561 |
) |
|
|
(5,994,561 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
Changes in fair value of warrant liability |
|
|
— |
|
|
|
1,547,982 |
|
|
Changes in fair value of embedded derivatives |
|
|
— |
|
|
|
(7,042 |
) |
|
Interest expense |
|
|
(740 |
) |
|
|
(870 |
) |
|
Interest income |
|
|
185,246 |
|
|
|
31,590 |
|
|
Other income (expense) |
|
|
46,749 |
|
|
|
257,725 |
|
|
Total other income (expense) |
|
|
231,255 |
|
|
|
1,829,385 |
|
|
Net loss before income tax benefit |
|
|
(2,097,306 |
) |
|
|
(4,165,176 |
) |
|
Income tax benefit |
|
|
— |
|
|
|
991,638 |
|
|
Net loss |
|
|
(2,097,306 |
) |
|
|
(3,173,538 |
) |
|
Other comprehensive income (loss) – foreign currency translation adjustments |
|
|
— |
|
|
|
615,471 |
|
|
Comprehensive loss |
|
$ |
(2,097,306 |
) |
|
$ |
(2,558,067 |
) |
|
Net loss |
|
$ |
(2,097,306 |
) |
|
$ |
(3,173,538 |
) |
|
Preferred stock accretion and other deemed dividends |
|
|
(452,925 |
) |
|
|
(1,891,321 |
) |
|
Net loss attributed to common stockholders |
|
$ |
(2,550,231 |
) |
|
$ |
(5,064,859 |
) |
|
Weighted-average common shares outstanding, basic and diluted |
|
|
9,489,765 |
|
|
|
676,552 |
|
|
Net loss per share attributed to common stockholders, basic and diluted |
|
$ |
(0.27 |
) |
|
$ |
(7.49 |
) |