Altimmune Announces Financial Results for the Year Ended December 31, 2020 and Provides a Corporate Update
Enrollment in the Phase 1 AdCOVID™ Clinical Trial has Commenced
Development of AdCOVID Vectors Targeting Emerging Variants of the SARS-CoV-2 Virus has Begun
ALT-801 is Progressing Through the Phase 1 Clinical Trial
Solidly Capitalized to Advance Pipeline Candidates with
“The past year has been a transformative time for our Company as we made substantial progress in each of our five portfolio programs,” said
- Commenced enrollment in AdCOVID Phase 1 clinical trial evaluating a novel, needle-free intranasal delivery approach for COVID-19 vaccination
Altimmune has commenced enrollment in its Phase 1 clinical trial of AdCOVID, which is designed to evaluate a needle-free intranasal delivery approach for vaccination against COVID-19. Altimmune believes AdCOVID has the potential to become a leading candidate for COVID-19 vaccination based on its ease of administration, and the potential for reduced disease transmission, and cold chain-free vaccine distribution, if the product is demonstrated to have extended stability at room temperature. As demonstrated in the NasoShield and NasoVax clinical trials, the Company believes the expected attributes of AdCOVID make it ideally suited for use in a pediatric setting as the intranasal administration and expected tolerability profile are well suited to meet the needs of children.
The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55. Subjects will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses. Altimmune anticipates having a full data readout from this Phase 1 study in Q2 2021.
- Initiated development of additional AdCOVID vectors targeting emerging SARS-CoV-2 variants
The emergence of SARS-CoV-2 variants is raising concerns about the effectiveness of currently authorized vaccines and prompting vaccine developers to engineer new vaccine candidates to combat these viral mutations. Altimmune has initiated the development of vaccine candidates against several variants as one is likely to become dominant in the population in the coming months. Altimmune plans to have these new vaccine candidates ready for use in upcoming later-stage clinical trials.
- Established a consortium of manufacturing partners for potential commercial supply of AdCOVID
Altimmune has executed agreements with three commercial manufacturing partners with significant experience in adenoviral vector production. The Company has also established relationships with leading drug product fill/finish partners with sufficient capacity to meet potential commercial demand. Together, the Company believes that this network of strategic manufacturing partners will ensure Altimmune’s commercial readiness to supply vaccine, assuming the clinical data support this advancement.
- Furthered AdCOVID preclinical studies in collaboration with the University of Alabama at
Birmingham (UAB)and Saint Louis University
Based on the promising preclinical data for AdCOVID published on the BioRxiv server, Altimmune continues preclinical studies of AdCOVID in collaboration with
- Commenced dosing in a Phase 1 clinical trial of ALT-801, a novel GLP-1/glucagon dual-agonist being evaluated for the treatment of NASH
Altimmune commenced dosing in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of ALT-801, a GLP-1/glucagon dual-agonist being developed for the treatment of NASH. This trial is being conducted in
- Amended clinical trial protocol to extend MAD cohorts to incorporate 12-week Phase 1b study in
Altimmune amended the clinical trial protocol for the ALT-801 Phase 1 clinical development program to incorporate its planned 12-week extension trial in patients with non-alcoholic fatty liver disease or NAFLD within the ongoing Phase 1 SAD/MAD trial in
- Initiated chronic toxicology studies of ALT-801 to enable 52-week Phase 2 clinical study
Altimmune completed 6-week and 13-week GLP toxicology studies of ALT-801 with no significant toxicity or GI adverse events. The Company has initiated 6-month and 9-month GLP toxicology studies to support the planned 52-week biopsy-driven Phase 2 trial planned for early 2022.
- Completed Cohorts 1 and 2 in the Phase 1/2 trial of T-COVID in patients with early COVID-19
Altimmune, working with the
Cohort 3 is an efficacy and safety cohort that will include patients at higher-risk for severe COVID-19 infection, such as those 65 years or older, or those with one or more risk factors for severe COVID-19 complications. To ensure that a sufficient number of higher risk patients are enrolled, the study protocol was recently modified to require that a minimum number of patients meet one or more of these criteria in this final cohort. Additional enrichments of the study population are currently being evaluated to increase the event rates in the trial. While these modifications could extend the study timeline, the Company believes they could significantly enhance the probability of a meaningful trial outcome. Based on these changes, data from this trial is now expected in Q2 2021.
- Commenced dosing in a multinational Phase 2 clinical trial of HepTcell
In December, Altimmune began a multinational Phase 2 clinical trial of HepTcell, which is being conducted in
HepTcell will be administered in 6 doses at 4-week intervals for 24 weeks, and patients will be followed for one year to evaluate safety and durability of response. The primary efficacy endpoint is virological response, defined as a 1-log reduction in HBsAg levels from baseline. Secondary efficacy endpoints include reactivation of anti-HBV T cell responses, HBsAg clearance, and other assessments of virologic response. Altimmune anticipates a data read-out from this trial in 1H 2022.
Financial Results for the Year Ended
- Altimmune had cash, cash equivalents and short-term investments of
$216.0 millionat December 31, 2020compared to $37.3 millionat December 31, 2019. The increase of $178.7 millionis attributable to $213.5 millionof net receipts during the year due primarily to its 2020 public offering, full utilization of the at-the-market offering program, and receipts from warrant exercises, offset by $34.4 millionof cash used for operating activities.
- Revenue was
$8.2 millionfor the year ended December 31, 2020compared to $5.8 millionin the prior year period, an increase of $2.4 million. The change was primarily due to an increase in revenue under the Company’s U.S.government contracts due to timing of manufacturing and clinical trials for the NasoShield and T-COVID programs.
- Research and development expenses were
$49.8 millionfor the year ended December 31, 2020, compared to $17.8 millionin the prior year period, representing an increase of $32.0 million. The increase was primarily attributable to increased costs related to development of AdCOVID, T-COVID and ALT-801 and an increase in the contingent liability for stock-based milestone payments associated with the acquisition of ALT-801.
- General and administrative expenses were
$13.2 millionfor the year ended December 31, 2020compared to $8.5 millionin the prior year period, an increase of $4.7 million. The increase is attributable to additional employee compensation as Altimmune’s workforce grew in 2020 along with an increase in professional costs.
- Income tax benefit was
$5.4 millionfor the year ended December 31, 2020, as compared to $59,000for the same period in 2019. The increase is attributable to the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) passed on March 27, 2020which made temporary changes regarding the utilization and carry back of net operating losses.
- Net loss attributed to common stockholders for the year ended
December 31, 2020was $49.0 million, or $1.91net loss per share, compared to $21.0 millionin the prior year, or $1.60net loss per share. The difference in net loss is primarily attributable to higher research and development expenses and general and administrative expenses, offset by higher revenue and an increase in income tax benefit.
Conference Call Information
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.
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.
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, statements regarding the impact of COVID-19 on our business operations, clinical trials and results of operations, the timing of key milestones for our clinical assets, the development and efficacy of vaccine candidates for SARS-CoV-2 variants, the data read-out for our Phase 1 clinical trial of AdCOVID in Q2 2021, the data readout from our T-COVID trial in Q2 2021, the data read-out from our Phase 1 clinical study for ALT-801 in Q1 2021, the plan to file an IND application for ALT-801 in mid-2021, the data read-out from our Phase 2 clinical trial of HepTcell in 1H 2022, 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 the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, 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
Investor & Media Contacts:
|Chief Financial Officer||Sr. Dir, Investor Relations|
|Phone: 240-654-1450||Phone : 410-474-8200|
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||115,917,807||$||8,962,686|
|Total cash, cash equivalents and restricted cash||115,951,981||8,996,860|
|Tax refund receivable||7,762,793||629,096|
|Prepaid expenses and other current assets||1,926,675||470,228|
|Total current assets||230,257,209||39,394,749|
|Property and equipment, net||1,056,920||1,104,208|
|Right of use asset||903,825||698,321|
|Intangible assets, net||12,823,846||12,732,195|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||11,408,154||3,904,767|
|Total current liabilities||12,020,447||3,922,999|
|Other long-term liabilities||1,828,443||1,864,875|
|Commitments and contingencies (Note 17)|
37,142,946 and 15,312,381 shares issued; 37,142,946 and 15,312,167 shares
|Additional paid-in capital||417,337,742||187,914,916|
|Accumulated other comprehensive loss, net||(5,044,517||)||(5,020,156||)|
|Total stockholders’ equity||225,876,323||45,520,146|
|Total liabilities and stockholders’ equity||$||245,115,213||$||54,058,020|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|Research and development||49,774,328||17,765,553|
|General and administrative||13,209,440||8,500,783|
|Total operating expenses||62,983,768||27,266,336|
|Loss from operations||(54,798,741||)||(21,464,935||)|
|Other income (expense):|
|Changes in fair value of warrant liability||—||30,000|
|Other income, net||24,147||15,139|
|Total other income, net||337,240||886,304|
|Net loss before income tax benefit||(54,461,501||)||(20,578,631||)|
|Income tax benefit||5,417,024||58,500|
|Other comprehensive (loss) income — unrealized (loss) gain on investments||(24,361||)||20,007|
|Net loss attributable to common stockholders||$||(49,044,477||)||$||(20,973,056||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(1.91||)||$||(1.60||)|
|Weighted-average common shares outstanding, basic and diluted||25,637,023||13,124,951|
Source: Altimmune, Inc.