• UB-612 Phase 3 COVID-19 Heterologous Boost Trial on Track for Topline Readout in Fourth Quarter of 2022
• UB-312 Phase 1 Part B Trial for Parkinson’s Completes Last Patient Last Dose, and Remains on Track to Complete an End-of-Treatment Analysis in the Second Half of 2022
• Advanced UB-313 Anti-CGRP Vaccine for Migraine into First-in-Human Trial
• Identified VXX-401 as Lead Anti-PCSK9 Vaccine Candidate for Hypercholesterolemia, Advanced to IND-Enabling Studies
DALLAS, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the second quarter ended June 30, 2022.
“We continue to advance our vaccine candidates further in clinical development and are delighted with the recent progress. We recently enrolled the first set of subjects into a Phase 1 clinical trial to study UB-313, our anti-CGRP candidate for migraine, and announced preclinical proof-of-concept data for our latest vaccine candidate, VXX-401, which demonstrated a significant reduction in cholesterol over a sustained period, further showcasing the capabilities of our platform in chronic diseases,” said Mei Mei Hu, CEO of Vaxxinity. “We remain diligent on strengthening our execution to advance the company’s pipeline and look forward to sharing clinical data updates in the second half of this year, including UB-312 in Parkinson’s disease, as well as our COVID-19 heterologous booster, UB-612.”
Second Quarter 2022 and Recent Updates
UB-311 FDA Fast Track Designation Granted
- UB-311 targets toxic forms of aggregated amyloid-β in the brain to fight Alzheimer’s disease (AD).
- In May 2022, UB-311 received Fast Track designation from the FDA for the treatment of AD. This designation will facilitate the development and expedite the review of UB-311.
- Vaxxinity plans to advance UB-311 into a registration-quality Ph2b early AD treatment trial, and other pivotal development, with a strategic partner, which may affect the trial initiation timeline.
UB-312 Phase 1 Clinical Trial Part B Completes Last Patient Last Dose
- UB-312 targets toxic forms of aggregated α-synuclein in the brain to fight Parkinson’s disease (PD) and other synucleinopathies.
- Phase 1 Part B trial evaluating UB-312 in PD has completed last patient last dose. Vaxxinity expects to complete an end-of-treatment analysis of Part B in the second half of 2022.
- Phase 1 Part A trial of UB-312 in healthy volunteers results published in Movement Disorders, April 15, 2022.
UB-313 Phase 1 Clinical Trial Enrollment Started
- UB-313 targets calcitonin gene-related peptide (CGRP) for the preventive treatment of migraine.
- Subsequent to the quarter-end, Vaxxinity began enrolling healthy volunteers into a Phase 1 clinical trial evaluating UB-313 for safety, tolerability, and immunogenicity. The trial also includes target engagement as a secondary endpoint in the form of capsaicin-induced dermal blood flow, a well established biomarker. Vaxxinity expects to report initial data from the Phase 1 study in 1H23.
VXX-401 Preclinical Proof-of-Concept Achieved, Advanced into IND-Enabling Studies
- VXX-401 targets proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower low-density lipoprotein (LDL) and reduce the risk of cardiac events.
- Two back-to-back studies in non-human primates demonstrate that VXX-401 is well tolerated and provides long-lasting, significant LDL reduction versus placebo.
- Vaxxinity has advanced VXX-401 into IND-enabling studies and expects to initiate a FIH trial by early 2023.
UB-612 Phase 3 Heterologous Boost Study Ongoing
- UB-612 employs a unique “multitope” approach to neutralizing the SARS-CoV-2 virus.
- Awarded CEPI grant for $9.2 million for Ph3 heterologous boost trial
- The Phase 3 heterologous boost study evaluating UB-612 against COVID-19 in subjects who have received primary immunization from mRNA, adenovirus vector, or inactivated viral vaccines is ongoing. Vaxxinity expects a topline readout in the second half of 2022, and if successful, these data will support global marketing authorization applications.
- Data on neutralizing antibodies against SARS=CoV-2 Omicron BA.1 and BA.2 following a booster dose of UB-612 published in The Journal of Infectious Diseases, June 20, 2022.
Second Quarter 2022 Financial Results
As of June 30, 2022, cash and cash equivalents were $109.1 million, as compared to $144.9 million on December 31, 2021. As of June 30, 2022, the Company also has a Restricted Cash balance of $4.7 million of which $4.6 million is restricted for the reimbursement of certain research and development expenses related to our UB-612 Covid vaccine program.
Research and development (R&D) expenses for the three months ended June 30, 2022 were $10.7 million compared to $19.0 million for the three months ended June 30, 2021. The $8.3 million decrease consisted of decreases in program-specific costs of $13.7 million and increases in non-program costs of $5.3 million. Of the program-specific decrease, $16.9 million was related to our UB-612 Covid vaccine program, partially offset by increases in spend of $1.3 million on our UB-313 migraine program and $0.7 million on our UB-312 Parkinson’s Disease program. The non-program increase was driven primarily by an increase of $4.2 million in personnel costs (including $0.6 million of stock-based compensation) as we added staff to advance our pipeline, and related overhead costs associated with our Florida lab space.
General and administrative (G&A) expenses for the three months ended June 30, 2022 were $6.6 million compared to $5.8 million for the three months ended June 30, 2021. The $0.8 million increase was primarily driven by an increase of $0.9 million in Directors and Officers (D&O) insurance and $0.7 million of salaries and personnel costs (including $0.4 million of stock-based compensation), partially offset by decreases of $1.0 million in consulting costs and professional services.
Net loss for the three months ended June 30, 2022 was $17.3 million or $0.14 per share compared to $26.9 million or $0.39 per share for the three months ended June 30, 2021.
Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. Vaxxinity’s is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. Vaxxinity’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health.
For more information about Vaxxinity, Inc., visit http://www.vaxxinity.com and follow us on social media @vaxxinity.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “look forward,” “may,” “expect,” “potentially,” and “will” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, and are based on the current expectations and assumptions of Vaxxinity’s management. Forward-looking statements include statements about the development of a new class of immunotherapeutic vaccines, the innovation and potential efficacy of Vaxxinity’s product candidates, and the anticipated outcomes from the studies we are conducting or will conduct for our product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Vaxxinity’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 24, 2022 and other reports we file with the Securities and Exchange Commission. The forward-looking statements are made as of this date and Vaxxinity does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
|Statement of Operations|
|(In thousands, except number of shares and per share amounts)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Cost of revenue||0||1,927||0||1,928|
|Gross (loss) profit||0||(1,927||)||0||(1,911||)|
|Research and development||10,664||19,020||22,142||30,708|
|General and administrative||6,560||5,846||13,246||14,430|
|Total operating expenses||17,224||24,866||35,388||45,138|
|Loss from operations||(17,224||)||(26,793||)||(35,388||)||(47,049||)|
|Other (income) expense:|
|Interest expense, net||105||109||210||620|
|Change in fair value of convertible notes||0||0||0||2,667|
|Change in fair value of simple agreement for future equity||0||0||0||8,365|
|Change in fair value of warrant liability||0||0||0||214|
|Foreign currency loss, net||(2||)||8||(3||)||16|
|Other (income) expense||28||115||127||11,880|
|Loss before income taxes||(17,252||)||(26,908||)||(35,515||)||(58,929||)|
|Provision for income taxes||0||0||0||0|
|Net loss per share, basic and diluted||(0.14||)||(0.39||)||(0.28||)||(0.86||)|
|Weighted average common shares outstanding, basic and diluted||125,948,595||68,702,833||125,829,764||68,627,943|
|Selected Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents||$||109,066||$||144,885|
|Total stockholder's equity (deficit)||97,341||128,619|