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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): May 13, 2025
ALTIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-32587 |
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20-2726770 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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910 Clopper Road, Suite 201S Gaithersburg, Maryland |
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20878 |
(Address of principal executive offices) |
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(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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 1.01 Entry into a Material Definitive Agreement
On May 13, 2025 (“Closing Date”), the Company and certain of its subsidiaries entered into a Loan and Security Agreement (“Loan Agreement”) with Hercules Capital, Inc. (“Hercules”) and the lenders party thereto, pursuant to which the lenders will make available up to four tranches of term loans in an aggregate principal amount of $100.0 million (the “Term Loan”), subject to certain terms and conditions.
Amount. The Loan Agreement provides for an aggregate of $100.0 million in term loans, which will be available to the Company in four tranches. The first Term Loan tranche was made on the Closing Date in an aggregate principal amount of $15.0 million. Upon the achievement of certain milestones and subject to other terms and conditions set out in the Loan Agreement, (i) the second Term Loan tranche will be made available in an aggregate principal amount of up to $25.0 million and (ii) the third Term Loan tranche will be made available in an aggregate principal amount of up to $15.0 million. The fourth Term Loan tranche will be made available in an aggregate principal amount of up to $45.0 million subject to the approval of the lenders.
Maturity Date. The Term Loan will mature on June 1, 2029 (the “Maturity Date”).
Interest Rate. The Term Loan bears interest equal to the greater of (a) the prime rate as reported in The Wall Street Journal plus 2.45% and (b) (i) 9.95% until December 31, 2025, and (ii) 9.45% thereafter.
Charges and fees. The Loan Agreement provides for an end of term charge equal to 6.25% of the funded loan amount, due at the earlier of prepayment or maturity. Pro-rata payment of any earned end of term charge will be due upon any partial prepayment. In addition, the Loan Agreement requires the Company to pay a facility charge of 1.0% of the Term Loan funded due at the Closing Date and of each subsequent Term Loan tranche at the time such tranche is funded. The Company will be required to pay a prepayment charge to the lenders in connection with certain voluntary prepayments of the Term Loans, which will be determined as a percentage of the Term Loans prepaid that decreases over time.
Term and Repayment. The Loan Agreement is for 48 months, with interest-only payments for an initial period of up to 24 months from the Closing Date, which may be extended up to 42 months upon achievement of certain milestones and subject to other terms and conditions set out in the Loan Agreement (the “Interest-Only Period”). After the Interest-Only Period, the Company will be required to repay in equal monthly installments the principal and interest until the Maturity Date.
Representations and Warranties and Covenant. The Loan Agreement includes customary representations and warranties and covenants associated with the Term Loan. Such terms include (1) covenants concerning financial and other reporting obligations, and (2) certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts. The Loan Agreement includes customary events of default, including payment defaults, breaches of representations and warranties, breaches of covenants following any applicable cure period and the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the Loan Agreement. In addition, the Loan Agreement includes affirmative and restrictive covenants, including maintenance of a minimum cash, cash equivalents and liquid funds covenant that applies beginning on April 1, 2026.
Collateral. The obligation under the Loan Agreement is secured by a security interest in substantially all of the Company’s assets and the assets of its subsidiaries that are co-borrowers or guarantors. Upon the occurrence of an event of default, Hercules and the lenders will be entitled to exercise remedies, including acceleration of the Term Loan obligations and foreclosure on collateral.
The foregoing descriptions of the Loan Agreement contained herein do not purport to be complete and are qualified in their entirety by reference to the complete text of the Loan Agreement to be filed with the SEC in connection with the Company’s first quarter 2025 Form 10-Q filing.
Item 2.02 Results of Operations and Financial Condition
On May 13, 2025, Altimmune, Inc. (the “Company”) issued a press release announcing the Company’s financial results for its first quarter ended March 31, 2025. 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 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant
The information set forth in Item 1.01 above is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure
On May 13, the Company issued a press release announcing the entering into of the Loan Agreement with Hercules. A copy of this press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information contained in this Item 7.01 and in the accompanying Exhibit 99.2 shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information in this Item 7.01 and the accompanying Exhibit 99.1 shall not be deemed to be “filed” for 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.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
No. |
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Description |
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99.1 |
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99.2 |
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104 |
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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.
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ALTIMMUNE, INC. |
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By: |
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/s/ Gregory Weaver |
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Name: Gregory Weaver |
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Title: Chief Financial Officer |
Dated: May 13, 2025
Exhibit 99.1
Altimmune Announces First Quarter 2025 Financial Results and Business Update
Top-line data from IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) expected in Q2 2025
Phase 2 trials in Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD), expected to initiate in Q2 and Q3 2025, respectively
Cash, cash equivalents and short-term investments of $150 million as of March 31, 2025
$100 million credit facility secured with Hercules Capital, adding balance sheet strength and financial flexibility to support continued development of pemvidutide
Webcast to be held today, May 13, 2025, at 8:30 a.m. ET
GAITHERSBURG, MD – May 13, 2025 – Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a business update.
“The first quarter of 2025 was productive for Altimmune as the Company approaches a number of important milestones,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “The readout of our IMPACT Phase 2b trial of pemvidutide in MASH is on-track for the second quarter of 2025. We believe that achieving statistical significance on MASH resolution and fibrosis improvement at only 24 weeks, coupled with clinically meaningful weight loss, would position pemvidutide as the best-in-class therapeutic candidate for the treatment of MASH.”
Dr. Garg continued, “At our recent R&D Day event we unveiled two additional indications for pemvidutide in AUD and ALD, and our intent to initiate Phase 2 clinical trials in these indications in Q2 and Q3, respectively. AUD and ALD are conditions of significant unmet medical need with limited treatment options. We remain committed to developing pemvidutide for treatment of liver and cardiometabolic diseases that leverage its differentiated clinical profile.”
Recent Highlights and Anticipated Milestones
MASH
| ● | Top-line data from the IMPACT Phase 2b trial of pemvidutide in biopsy-confirmed F2/F3 MASH expected in Q2 2025 |
| o | Top-line data is expected to include rates of MASH resolution and fibrosis improvement, weight loss, non-invasive tests, and data on safety and tolerability. |
| o | A total of 212 participants were randomized, exceeding the 190 originally planned. |
| o | If successful, pemvidutide would be the first investigational therapy in MASH to achieve statistical significance in both MASH resolution and fibrosis improvement, as well as demonstrate meaningful weight loss, after only 24 weeks of treatment. |
| ● | Altimmune presented new data at the EASL International Liver Congress™ 2025, including a follow-on analysis of the Company’s Phase 1b trial in MASLD using the MASH Resolution Index (MASHResInd) |
| o | Developed by Dr. Rohit Loomba, Professor of Medicine and Chief of Gastroenterology and Hepatology at the University of California San Diego, MASHResInd is a non-invasive measure that has been highly predictive of MASH resolution. |
| o | The analyses indicated that after 24 weeks of treatment, the proportion of participants receiving pemvidutide achieving MASHResInd responses exceeded 90%. These findings indicate that high rates of MASH resolution may be observed in the upcoming IMPACT Phase 2b MASH trial readout. |
Additional Indications for Pemvidutide: AUD and ALD
| ● | During Altimmune’s R&D Day, the Company announced the development of pemvidutide in two additional indications: AUD and ALD |
| o | AUD and ALD are characterized by large patient populations with significant unmet medical need and very few treatment options. |
| o | Investigational New Drug (IND) applications were cleared by the FDA in the first quarter of 2025. The Phase 2 trials in AUD and ALD are expected to initiate in the second and third quarters of 2025, respectively. |
| o | Preclinical data and data from other clinical trials support the potential of pemvidutide to reduce alcohol consumption, improve liver health, and provide the added benefit of meaningful weight loss. |
Corporate Update
| ● | The Company entered into a $100 million credit facility with Hercules Capital (NYSE: HTGC), with an initial $15 million tranche funded at closing. An additional $25 million is available in 2025 at Altimmune’s option, subject to the achievement of certain clinical and financial milestones. The remaining $60 million is available beginning in 2026, with $15 million subject to the achievement of certain clinical and financial milestones and up to $45 million available subject to approval of Hercules. The credit facility significantly increases Altimmune’s financial strength and flexibility on attractive terms. |
Financial Results for the Three Months Ended March 31, 2025
| ● | Altimmune reported cash, cash equivalents and short-term investments totaling $150 million as of March 31, 2025. |
| ● | Research and development expenses were $15.8 million for the three months ended March 31, 2025, compared to $21.5 million in the same period in 2024, the decrease resulting from timing of clinical trial costs. The expenses for the quarter ended March 31, 2025, included $9.2 million in direct costs related to pemvidutide development activities. |
| ● | General and administrative expenses were $6.0 million for the three months ended March 31, 2025, compared to $5.3 million in the same period in 2024. The increase was primarily due to a $0.5 million increase in stock compensation and other labor-related expenses. |
| ● | Interest income was $1.5 million for the three months ended March 31, 2025, compared to $2.4 million for the same period in 2024. |
| ● | Net loss for the three months ended March 31, 2025, was $19.6 million, or $0.26 net loss per share, compared to a net loss of $24.4 million, or $0.34 net loss per share, in the same period in 2024. |
Conference Call Information:
Date: |
May 13, 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. |
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 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of MASH, obesity, Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD). 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 completed the MOMENTUM Phase 2 obesity trial in 2024 and is being studied in the ongoing IMPACT Phase 2b MASH trial with top line results expected in late June 2025. IND applications in AUD and ALD have received FDA clearance with Phase 2 trials scheduled to commence in Q2 and Q3 2025, respectively.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, obesity, Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD). For more information, please visit www.altimmune.com.
Follow @Altimmune, Inc. on LinkedIn
Follow @AltimmuneInc on X
Forward-Looking Statement
Any statements made in this press release related to the use of our credit facility with Hercules, development or commercialization of product candidates and other business and financial 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 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:
Jake Robison |
Inizio Evoke Comms |
Phone: 619-849-5383 |
jake.robison@inizioevoke.com |
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per-share amounts)
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March 31, |
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December 31, |
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2025 |
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2024 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
49,104 |
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$ |
36,926 |
Restricted cash |
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42 |
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42 |
Total cash, cash equivalents and restricted cash |
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49,146 |
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36,968 |
Short-term investments |
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100,722 |
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94,965 |
Accounts and other receivables |
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507 |
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544 |
Income tax and R&D incentive receivables |
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1,957 |
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2,573 |
Prepaid expenses and other current assets |
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2,930 |
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2,204 |
Total current assets |
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155,262 |
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137,254 |
Property and equipment, net |
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384 |
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413 |
Other assets |
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1,617 |
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1,639 |
Total assets |
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$ |
157,263 |
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$ |
139,306 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,077 |
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$ |
211 |
Accrued expenses and other current liabilities |
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8,721 |
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10,257 |
Total current liabilities |
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9,798 |
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10,468 |
Other noncurrent liabilities |
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5,303 |
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5,330 |
Total liabilities |
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15,101 |
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15,798 |
Commitments and contingencies |
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Stockholders’ equity: |
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Common stock, $0.0001 par value; 200,000,000 shares authorized; 77,825,450 and 72,352,701 shares issued and outstanding as of March 31, 2025 and December 31 2024, respectively |
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8 |
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7 |
Additional paid-in capital |
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728,122 |
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689,864 |
Accumulated deficit |
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(580,965) |
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(561,390) |
Accumulated other comprehensive loss, net |
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(5,003) |
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(4,973) |
Total stockholders’ equity |
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142,162 |
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123,508 |
Total liabilities and stockholders’ equity |
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$ |
157,263 |
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$ |
139,306 |
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per-share amounts)
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Three Months Ended |
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March 31, |
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2025 |
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2024 |
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Revenues |
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$ |
5 |
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$ |
5 |
Operating expenses: |
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Research and development |
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15,827 |
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21,487 |
General and administrative |
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5,993 |
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5,312 |
Total operating expenses |
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21,820 |
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26,799 |
Loss from operations |
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(21,815) |
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(26,794) |
Other income (expense): |
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Interest expense |
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(1) |
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(1) |
Interest income |
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1,545 |
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2,413 |
Other income (expense), net |
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15 |
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(12) |
Total other income (expense), net |
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1,559 |
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2,400 |
Net loss before income taxes |
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(20,256) |
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(24,394) |
Income tax expense (benefit) |
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(681) |
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— |
Net loss |
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(19,575) |
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(24,394) |
Other comprehensive income — unrealized gain on short-term investments |
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(30) |
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(157) |
Comprehensive loss |
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$ |
(19,605) |
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$ |
(24,551) |
Net loss per share, basic and diluted |
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$ |
(0.26) |
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$ |
(0.34) |
Weighted-average common shares outstanding, basic and diluted |
|
|
75,547,746 |
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70,801,713 |
Exhibit 99.2
Altimmune Secures Up to $100 Million in Credit Facility from Hercules Capital
Term loan adds balance sheet strength and provides financial flexibility to support continued development of pemvidutide
GAITHERSBURG, MD – May 13, 2025 – Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC), a leader in debt financing for life science companies, for up to $100 million in a credit facility, with a $15 million tranche funded at closing. Additional tranches will become available upon achievement of certain clinical and financial milestones aligned with the Company’s pemvidutide development plans and financing needs.
Access to this additional capital strengthens Altimmune’s balance sheet, which included $150 million in cash and cash equivalents as of March 31, 2025, and will support the ongoing development of pemvidutide, Altimmune’s novel GLP-1/glucagon dual receptor agonist. Pemvidutide is currently being studied in IMPACT, a Phase 2b trial in metabolic dysfunction-associated steatohepatitis (MASH), with top-line data expected in Q2 2025. In addition, Phase 2 trials evaluating pemvidutide in Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) are expected to be initiated in the second and third quarters of 2025, respectively.
Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune said, “We are excited to partner with Hercules, which has a strong history of funding innovative biopharmaceutical companies. We look forward to working with the Hercules team to maximize the potential of pemvidutide in liver and cardiometabolic indications. With our existing cash on hand, we expect this credit facility to significantly extend our cash runway at flexible, attractive terms.”
“Hercules is thrilled to support Altimmune as it develops pemvidutide as a potential therapy for the treatment of MASH, AUD and ALD,” said Adam Soller, Managing Director at Hercules Capital. “We look forward to the upcoming data release from the IMPACT trial and serving as a long-term capital partner to Altimmune through its next chapter of clinical development.”
Under the terms of the agreement, $15 million will be drawn at closing. An additional $25 million is available in 2025 at Altimmune’s option, subject to certain clinical and financial milestones. The remaining $60 million is available beginning in 2026, with $15 million subject to the achievement of certain clinical and financial milestones and up to $45 million available subject to the approval of Hercules. The facility is structured as interest only for the first 24 months, extendable up to 42 months on achievement of milestones. The loan matures 48 months from closing, and no warrants are included in the agreement.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, obesity, Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD). For more information, please visit www.altimmune.com.
Follow @Altimmune, Inc. on LinkedIn
Follow @AltimmuneInc on X
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:
Jake Robison |
Inizio Evoke Comms |
Phone: 619-849-5383 |
jake.robison@inizioevoke.com |