SAN JOSE, Calif., Nov. 13, 2018 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of targeted immunotherapies using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections, today announces financial results, a company update and product overview for the three and nine months ended September 30, 2018.
On August 16, 2018, Aridis completed its initial public offering of 2.2 million shares of its common stock which included an overallotment of 192,824 shares that was exercised on August 30 resulting in net proceeds of approximately $25.1 million. As of September 30, 2018 Aridis had cash and cash equivalents of $34.1 million, which management believes is sufficient to fund operations into 2020. These resources are expected to enable the Company to advance its multi-product clinical pipeline toward the achievement of key clinical milestones in 2018 and 2019.
"We are very pleased to have successfully completed our recent IPO and are grateful to our new and existing investors for their enthusiastic participation and continued support," said Vu Truong, Ph.D., Founder and CEO of Aridis. "The proceeds from the IPO will enable us to advance our clinical and preclinical pipeline of novel, fully human, anti-infective monoclonal antibodies targeting serious, potentially life-threatening infections toward near-term clinical milestones, including initiation of the AR-301 Phase 3 clinical study around the end of this year."
Dr. Truong added, "We believe that the future treatment of life-threatening infections, such as hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), will shift toward a targeted approach, using drugs that are specific to just the pathogen that is infecting the patient, rather than drugs that induce a broad spectrum killing effect such as the current standard of care antibiotics. We are pleased that patient enrollment in the global Phase 2 clinical study evaluating AR-105 for the treatment of VAP is steady as expected. Thus, we remain on track to report top-line data from this study in mid-2019."
Product Overview and Clinical Progress
Additional Q3 Highlights
Fiscal Third Quarter Results
About Aridis' mAbs
Fully human monoclonal antibodies (mAbs) against infectious disease targets are a growing area of interest as a therapeutic modality due to their strong safety profile in humans, long plasma half-life and low risk of drug resistance. Aridis has developed a suite of proprietary human mAbs as anti-infective drugs targeting key human pathogens, including S. aureus (MRSA & MSSA), P. aeruginosa, A. baumannii bacteria and respiratory syncytial virus, or RSV.
About Aridis' MabIgX® Antibody Discovery Platform
Aridis' MabIgX® technology is designed to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection. Aridis' proprietary fusion cell line immortalizes active, antibody-producing human B-cells with remarkable stability, enabling large-scale manufacturing of these fully human mAbs to be used as possible therapies to protect the general population.
Unlike current antibody therapies being developed for infectious diseases, Aridis' mAbs are completely of human origin, functionally optimized for high potency by the patient's immune system, and do not require genetic engineering or further optimization to achieve full functionality and high mAb productivity. This technology also allows for the selection of any antibody isotype, depending on the optimal effector function required for treating the target infection. Bypassing the humanization, binding sequence optimization, and generation of genetically engineered antibody producing cell lines allows for a much faster progression to clinical development compared to other companies developing antibody therapies.
Key competitive advantages of Aridis' MabIgX® antibody discovery platform and the resulting fully human mAbs include:
About Aridis Pharmaceuticals, Inc.
Aridis (Nasdaq: ARDS) is a late-stage biopharmaceutical company focused on discovering and developing targeted immunotherapies using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections. The use of mAbs represents an innovative treatment approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care, broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of response, perturbation of the human microbiome and lack of differentiation among current treatments. Aridis' pipeline includes AR-101, a fully human immunoglobulin mAb targeting P. aeruginosa serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired infections worldwide; AR-301, a fully human immunoglobulin 1, or IgG1, mAb targeting hospital-acquired pneumonia, or HAP, and ventilator-associated pneumonia, or VAP, S. aureus alphatoxin; AR-105, a fully human IgG1 mAb being developed to treat acute pneumonia caused by P. aeruginosa infection; AR-501, a broad spectrum small molecule anti-infective being developed to manage chronic lung infections in cystic fibrosis patients; AR-401, the Company's preclinical mAb program aimed at treating infections caused by Acinetobacter baumannii; and AR-201, a fully human IgG1 mAb that neutralizes diverse clinical isolates of RSV.
For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof. Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Aridis Pharmaceuticals, Inc. |
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Condensed Consolidated Balance Sheets |
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(In thousands, except share and per share amounts) |
|||
September 30, |
December 30 |
||
2018 |
2017 |
||
Cash and cash equivalents |
$ 34,077 |
$ 25,096 |
|
Other current & noncurrent assets |
$ 4,496 |
$ 1,382 |
|
Total assets |
$ 38,573 |
$ 26,478 |
|
Total liabilities |
$ 7,203 |
$ 15,042 |
|
Total convertible preferred stock |
$ - |
$ 74,202 |
|
Total stockholders' deficit |
$ 31,370 |
(62,766) |
|
Total liabilities, convertible preferred stock and stockholders' deficit |
$ 38,573 |
$ 26,478 |
Aridis Pharmaceuticals, Inc. |
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Condensed Consolidated Statements of Operations |
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(In thousands, except share and per share amounts) |
||||||||
Three Months Ended |
Nine Months |
|||||||
2018 |
2017 |
2018 |
2017 |
|||||
Revenues |
$ 1,022 |
$ 22 |
$ 1,367 |
$ 67 |
||||
Operating expenses* |
||||||||
Research and development |
6,907 |
4,859 |
17,418 |
12,836 |
||||
General and administrative |
735 |
649 |
2,489 |
2,516 |
||||
Total operating expenses |
7,642 |
5,508 |
19,907 |
15,352 |
||||
Loss from operations |
(6,620) |
(5,486) |
(18,540) |
(15,285) |
||||
Other income (expense): |
||||||||
Interest and other income (expense), net |
119 |
64 |
262 |
162 |
||||
Change in fair value of warrant liability |
(1,388) |
4 |
1,632 |
(4,589) |
||||
Loss from equity method investment |
(20) |
- |
(20) |
- |
||||
Net loss |
$ (7,909) |
$ (5,418) |
$ (16,666) |
$ (19,712) |
||||
Preferred dividends |
$ (5) |
$ (788) |
$ (1,357) |
$ (2,023) |
||||
Net loss available to common stockholders |
$ (7,914) |
$ (6,206) |
$ (18,023) |
$ (21,735) |
||||
Weighted-average common shares outstanding, |
4,019,459 |
166,373 |
1,469,623 |
166,373 |
||||
Net loss per common share, basic and diluted |
$ (1.97) |
$ (32.57) |
$ (11.34) |
$ (118.49) |
||||
Preferred dividends, basic and diluted |
$ (0.00) |
$ (4.73) |
$ (0.92) |
$ (12.16) |
||||
Loss per share available to common stockholders, |
$ (1.97) |
$ (37.30) |
$ (12.26) |
$ (130.65) |
||||
*Includes stock-based compensation as follows |
||||||||
Research and development |
$ 159 |
$ 92 |
$ 439 |
$ 218 |
||||
General and administrative |
235 |
111 |
745 |
971 |
||||
$ 394 |
$ 203 |
$ 1,184 |
$ 1,189 |
Contact:
Lisa Sher
Head of Investor & Public Relations
Sherl@aridispharma.com
+1 (970) 987-2654 (Direct)
SOURCE Aridis Pharmaceuticals, Inc.