Ventyx Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Corporate Progress
- None.
- Net loss increased in Q4 2023 compared to the same period in 2022, reaching $46.8 million.
- R&D expenses significantly rose in Q4 2023 compared to Q4 2022, totaling $42.0 million.
- Despite positive pipeline updates, the company reported a higher net loss for the full year 2023 compared to 2022, amounting to $193.0 million.
The financial results of Ventyx Biosciences indicate a significant increase in Research and Development (R&D) expenses from $87.7 million in the previous year to $175.8 million in the current year. This reflects the company's intensified efforts in advancing its clinical trials. The doubling of R&D investment can be seen as a positive signal of the company's commitment to its pipeline, but it also raises the burn rate, which is critical for investors to monitor. The cash position of $252.2 million, expected to last into H2 2025, provides a runway that may reassure investors in the short to medium term. However, the net loss widening from $108.4 million to $193.0 million year-on-year could be a cause for concern, potentially impacting the company's stock price if profitability is not achieved in the foreseeable future.
The clinical updates from Ventyx's NLRP3 portfolio are of particular interest, as NLRP3 inhibitors are being explored for a broad range of inflammatory diseases. The topline results from the Phase 2 trial of VTX2735 in CAPS patients and the Phase 1 trial of VTX3232 in healthy volunteers could have significant implications if positive. The focus on a potential best-in-disease oral agent for ulcerative colitis (UC) with VTX002 indicates a strategic move to position the company in a market with high unmet needs. The streamlined design of the VTX958 trial for Crohn's disease could expedite the trial process and potentially bring a new treatment to market faster. These developments could lead to future partnerships, licensing deals, or increased investor interest, especially if the Phase 3 trial of VTX002 in UC commences as planned in the second half of 2024.
Investor sentiment may be influenced by the upcoming virtual investor event, which is expected to provide critical updates on Ventyx's pipeline. The market for inflammatory diseases is competitive and the success of the NLRP3 inhibitors could position Ventyx favorably within this space. The anticipation of topline results from ongoing trials may lead to volatility in the company's stock as the market reacts to new data. Moreover, the amendment to the VTX958 trial protocol suggests a strategic pivot to enhance the efficiency of the trial, which could be perceived positively by the market, provided it does not compromise the integrity of the trial results. Additionally, the company's belief in the potential of its CNS-penetrant NLRP3 inhibitor for neuroinflammatory conditions taps into a market with a significant demand for innovative treatments.
Ventyx to host virtual investor event on March 11th to provide clinical updates on our NLRP3 portfolio and from the open-label extension of the VTX002 Phase 2 trial in ulcerative colitis
Cash, cash equivalents and marketable securities of
SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent pipeline and business progress.
“We look forward to sharing a number of clinical updates at our virtual investor event on March 11th,” said Raju Mohan, Chief Executive Officer. “This includes topline results from the Phase 2 trial of our peripheral NLRP3 inhibitor VTX2735 in patients with CAPS and topline results from the Phase 1 trial of our CNS-penetrant NLRP3 inhibitor VTX3232 in healthy volunteers. We will also provide an update from the ongoing open-label extension of the VTX002 Phase 2 trial in ulcerative colitis.”
Pipeline Updates
- VTX002 (S1P1R Modulator): In October 2023, we announced positive results from the Phase 2 trial of VTX002 in patients with moderately to severely active ulcerative colitis (UC). We believe these data establish VTX002 as a potential best-in-disease oral agent in UC based on its differentiated efficacy profile, including a high rate of complete endoscopic remission, and its potential best-in-class safety profile. We will provide additional data from the open-label extension of the Phase 2 UC trial at our virtual investor event. Activities are underway to support initiation of a Phase 3 trial of VTX002 in UC during the second half of 2024.
- VTX958 (TYK2 Inhibitor): We are evaluating VTX958 in a Phase 2 trial in patients with moderately to severely active Crohn’s disease. We recently implemented a protocol amendment for the ongoing Phase 2 trial to streamline trial design and accelerate potential detection of an efficacy signal. As a result of the protocol amendment, target enrollment in the trial was revised from approximately 132 patients to approximately 93 patients. The trial’s sole primary endpoint is now the change from baseline in the mean Crohn’s disease activity index (CDAI) score at Week 12. We anticipate completing randomization of the trial during the first quarter of 2024 and we expect to report topline results from the Phase 2 Crohn’s disease trial during the middle of 2024.
- VTX2735 (Peripheral NLRP3 Inhibitor): We are conducting a Phase 2 trial of VTX2735 in patients with familial cold autoinflammatory syndrome (FCAS). FCAS is the most common subset of cryopyrin-associated periodic syndrome (CAPS), a group of rare autoinflammatory conditions caused by gain-of-function mutations in the NLRP3 gene. Patient enrollment in the Phase 2 trial is complete and we expect to report topline results from the trial at our virtual investor event.
- VTX3232 (CNS-penetrant NLRP3 Inhibitor): We are conducting a Phase 1 trial of VTX3232 in adult healthy volunteers. The trial is designed to characterize the safety, pharmacokinetics and pharmacodynamics of VTX3232 in blood, and is also measuring drug concentration and target engagement in the cerebral spinal fluid. We expect to report topline results from the Phase 1 trial of VTX3232 at our virtual investor event.
In addition to CAPS, we believe that our portfolio of novel oral NLRP3 inhibitors is well positioned to address a broad range of inflammatory conditions associated with activation of the NLRP3 inflammasome. This includes systemic inflammatory conditions, such as dermatologic, rheumatic and cardiometabolic diseases, including obesity. We also believe that NLRP3 inhibition in the CNS represents a compelling potential therapeutic approach for a range of neuroinflammatory conditions with high unmet medical need, including Parkinson’s disease, multiple sclerosis, Alzheimer’s disease and amyotrophic lateral sclerosis, among others.
Virtual Investor Event
Ventyx will host a virtual investor event on March 11, 2024, to provide key clinical updates on our NLRP3 portfolio, including topline results from the Phase 2 trial of VTX2735 in CAPS and topline results from the Phase 1 trial of VTX3232 in healthy volunteers. We will also provide a clinical update from the ongoing open-label extension of the VTX002 Phase 2 trial in ulcerative colitis. Timing and dial-in details will be announced one week prior to the event.
Fourth Quarter and Full Year 2023 Financial Results:
- Cash Position: Cash, cash equivalents and marketable securities were
$252.2 million as of December 31, 2023. We believe our current cash, cash equivalents and marketable securities are sufficient to fund our planned operations into at least the second half of 2025. - Research and Development (R&D) expenses: R&D expenses were
$42.0 million for the fourth quarter of 2023, compared to$30.2 million for the fourth quarter of 2022. R&D expenses were$175.8 million for the year ended December 31, 2023, compared to$87.7 million for the year ended December 31, 2022. - General and Administrative (G&A) expenses: G&A expenses were
$8.3 million for the fourth quarter of 2023, compared to$8.4 million for the fourth quarter of 2022. G&A expenses were$32.2 million for the year ended December 31, 2023, compared to$25.4 million for the year ended December 31, 2022. - Net loss: Net loss was
$46.8 million for the fourth quarter of 2023, compared to$35.2 million for the fourth quarter of 2022. Net loss was$193.0 million for the year ended December 31, 2023, compared to$108.4 million for the year ended December 31, 2022.
About Ventyx Biosciences
Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical need with novel oral therapies that can shift immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting TYK2, S1P1R and NLRP3, positioning us to become a leader in the development of oral immunology therapies. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com.
Forward-Looking Statements
Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Ventyx’s product candidates, including the positioning of Ventyx’s NLRP3 inhibitors to address a broad range of inflammatory conditions associated with activation of the NLRP3 inflammasome, including dermatologic, rheumatic and cardiometabolic diseases, such as obesity; the anticipated continued progression of the development pipeline for Ventyx’s product candidates; the anticipated continuance of the Phase 2 trial of VTX958 in Crohn’s disease; the therapeutic and commercial potential of VTX002 in ulcerative colitis, including its potential as a best-in-disease oral agent and its potential best-in-class safety profile; and the anticipated timing of updates regarding the VTX958 Phase 2 trial in Crohn’s disease, the VTX3232 Phase 1 trial, the VTX2735 Phase 2 trial in CAPS, and the open-label extension of the VTX002 Phase 2 trial. The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as a trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of Ventyx’s product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx’s ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx’s prior press releases and Ventyx’s filings with the Securities and Exchange Commission (SEC), including in Part I, Item 1A (Risk Factors) of Ventyx’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on or about the date hereof, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Relations Contact
Patti Bank
Managing Director
ICR Westwicke
(415) 513-1284
IR@ventyxbio.com
| Ventyx Biosciences, Inc. | |||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||
| (in thousands, except share and per share amounts) | |||||||||||||||||
| Three months ended December 31, | Year ended December 31, | ||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 42,020 | $ | 30,185 | $ | 175,767 | $ | 87,738 | |||||||||
| General and administrative | 8,326 | 8,386 | 32,227 | 25,398 | |||||||||||||
| Total operating expenses | 50,346 | 38,571 | 207,994 | 113,136 | |||||||||||||
| Loss from operations | (50,346 | ) | (38,571 | ) | (207,994 | ) | (113,136 | ) | |||||||||
| Other (income) expense: | |||||||||||||||||
| Interest income | (3,621 | ) | (3,185 | ) | (15,074 | ) | (4,669 | ) | |||||||||
| Other (income) expense | 28 | (172 | ) | 42 | (41 | ) | |||||||||||
| Total other (income) expense | (3,593 | ) | (3,357 | ) | (15,032 | ) | (4,710 | ) | |||||||||
| Net loss | $ | (46,753 | ) | $ | (35,214 | ) | $ | (192,962 | ) | $ | (108,426 | ) | |||||
| Unrealized gain (loss) on marketable securities | 577 | 181 | 1,121 | (1,023 | ) | ||||||||||||
| Foreign currency translation | (120 | ) | 8 | (48 | ) | (42 | ) | ||||||||||
| Comprehensive loss | $ | (46,296 | ) | $ | (35,025 | ) | $ | (191,889 | ) | $ | (109,491 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.79 | ) | $ | (0.62 | ) | $ | (3.30 | ) | $ | (2.07 | ) | |||||
| Weighted average common shares outstanding, basic and diluted | 59,076,498 | 56,723,942 | 58,542,974 | 52,471,003 | |||||||||||||
| Ventyx Biosciences, Inc. | |||||||||
| Selected Consolidated Balance Sheet Data | |||||||||
| (in thousands) | |||||||||
| December 31, | |||||||||
| 2023 | 2022 | ||||||||
| Cash, cash equivalents and marketable securities | $ | 252,220 | $ | 356,613 | |||||
| Working capital | 242,080 | 314,329 | |||||||
| Total assets | 277,693 | 371,400 | |||||||
| Total liabilities | 33,770 | 17,505 | |||||||
| Accumulated deficit | (419,187 | ) | (226,225 | ) | |||||
| Total stockholders' equity | 243,923 | 353,895 | |||||||
