Talphera Announces First Quarter 2024 Financial Results and Provides Corporate Update
Talphera (Nasdaq: TLPH) announced its Q1 2024 financial results and provided a corporate update. The company reported cash and investments of $18.6 million as of March 31, 2024. Combined R&D and SG&A expenses were $4.2 million, down from $5.3 million in Q1 2023, due to reduced headcount from divesting DSUVIA. Net loss from continuing operations was $4.0 million, compared to net income of $0.1 million in Q1 2023, due to changes in the fair value of the company's warrant liability. The NEPHRO CRRT study is set to enroll its first patients in Q2 2024. Dr. Shakil Aslam joins as Chief Development Officer on May 20, 2024.
- Cash and investments at $18.6 million as of March 31, 2024.
- Combined R&D and SG&A expenses reduced to $4.2 million from $5.3 million in Q1 2023.
- Net loss reduced to $4.0 million in Q1 2024 from $8.2 million in Q1 2023.
- NEPHRO CRRT study ready to enroll first patients in Q2 2024.
- Dr. Shakil Aslam joins as Chief Development Officer, enhancing nephrology expertise.
- Net loss from continuing operations at $4.0 million compared to net income of $0.1 million in Q1 2023.
- Initial site activation for NEPHRO CRRT study delayed, revising previous guidance on top-line data availability.
- Q1 2024 financial results reflect a change in fair value of the company's warrant liability.
Insights
Talphera's Q1 2024 financial results reveal several key points that investors should consider. The
The company reported a
Additionally, the net loss per share decreased significantly to
In summary, Talphera's financials are mixed: while expenses are under control, the net loss from continuing operations and reliance on clinical trial outcomes must be carefully monitored. Investors should keep an eye on cash reserves and how efficiently the company progresses with its NEPHRO CRRT study, as these factors will likely impact future financial stability and stock performance.
The initiation of the NEPHRO CRRT registrational study is a pivotal development for Talphera. This study's outcome could significantly influence the company's future. The clinical trial agreements with five large academic institutions underscore the credibility and potential impact of this research. However, delays in site activation have pushed back the expected topline data release, initially slated for September 30. For retail investors, it’s important to understand that such delays are not uncommon in clinical trials, but they do introduce an element of uncertainty regarding the timeline.
The addition of Dr. Shakil Aslam as Chief Development Officer is another noteworthy aspect. Dr. Aslam brings over 20 years of experience in renal diseases, which could prove invaluable in advancing the NEPHRO study and other nephrology-focused projects. His expertise could enhance the trial's design and execution, potentially mitigating some risks associated with clinical trials and increasing the likelihood of positive outcomes.
Investors should watch for updates on patient enrollment and any interim results from the NEPHRO study. Successful early results could significantly boost investor confidence and positively impact the stock price. Conversely, any further delays or adverse outcomes could have a negative impact.
Talphera's rebranding and shift in focus to nephrology signal a strategic pivot aimed at capturing a niche market segment. The rebranding from AcelRx Pharmaceuticals and the company's new ticker symbol 'TLPH' reflect a comprehensive effort to realign the corporate identity with its new therapeutic focus. This move is important for investors as it can attract a more specialized investor base and potentially lead to more focused marketing and sales strategies.
The company’s recent capital commitment announcements, totalling
Investors should consider the impact of these strategic changes and capital commitments on the company's long-term growth prospects. The focus on nephrology, backed by significant financial resources and expert leadership, positions Talphera well in a specialized market. However, the success of this strategy hinges on the timely and successful completion of the NEPHRO study.
First patients at multiple sites are expected to be enrolled in the NEPHRO CRRT registrational study in Q2 2024
Dr. Shakil Aslam, an expert in renal diseases, including acute kidney injury, joins Talphera as Chief Development Officer
Cash and investments at March 31, 2024 of
Conference call and webcast to be held Tuesday, May 14, 2024 at 4:30 pm ET
"We are eager to have the first patient enrolled in the NEPHRO study so we can complete this pivotal trial and demonstrate the efficacy and safety of this unique anticoagulant. We have finalized clinical trial agreement terms with five large academic institutions and are awaiting these sites to complete their final internal start-up activities before patients are enrolled," stated Vince Angotti, CEO of Talphera. "While the initial site activation has taken longer than expected, based on our ongoing discussions with the principal investigators, they are eager to get started and expect the trial will complete quickly given the primary endpoint is measured at 24 hours. As a result of the initial delays, we expect that our previous guidance of having top-line data available by September 30 will be revised. Once patients begin enrolling, we plan to provide an updated expected study completion date. Finally, the addition of Dr. Aslam to Talphera will provide significant nephrology expertise to the team and further support the development and commercial preparation of Niyad," continued Angotti.
First quarter 2024 and recent highlights
- In January of this year, the Company announced a corporate rebranding, changing its name from AcelRx Pharmaceuticals, Inc. to Talphera, Inc. The decision to rebrand was made following the divestment of assets indicated for acute pain and the shift in focus to its new lead asset, Niyad, reinforcing the Company's vision of developing and commercializing products to support healthcare providers in optimizing outcomes in medically supervised settings. Talphera began trading on the Nasdaq Global Market under the ticker symbol "TLPH" on January 10, 2024.
- In January 2024, Talphera announced a total of
$26 million in committed capital, including (i)$8 $18 million $6 $10 million of committed capital upon the announcement of positive NEPHRO registration trial data, and an additional$2 million commitment if Talphera stock trades above a specified price following that announcement. - Clinical trial agreements with five large academic institutions have been finalized, and we await completion of their final internal start-up activities so these sites can begin enrolling patients. First patients are expected to be enrolled at multiple sites in the second quarter of this year.
- Dr. Shakil Aslam will join Talphera effective May 20, 2024 as Chief Development Officer. Dr. Aslam has over 20 years of clinical and research experience across a broad therapeutic range including renal and vascular disease and acute kidney injury. He joins Talphera from BioCryst Pharmaceuticals where he was the Vice President, Clinical Development, Nephrology and Rare Diseases. Dr. Aslam previously held roles at Angion Biomedica, Fresenius Medical Care and Amgen and was an assistant professor at
Georgetown University hospital for eleven years with a focus on acute and chronic kidney disease, hypertension, renal transplantation, and other nephrological diseases.
First Quarter 2024 Financial Information
- The cash and cash equivalents balance was
$18.6 million as of March 31, 2024. - Combined R&D and SG&A expenses for the first quarter of 2024 totaled
$4.2 million compared to$5.3 million for the first quarter of 2023. Excluding non-cash stock-based compensation expense, these amounts were$3.9 million for the first quarter of 2024, compared to$4.8 million for the first quarter of 2023. The decrease in combined R&D and SG&A expenses in the first quarter of 2024 was primarily due to reduced headcount attributed to the divestment of DSUVIA. - For the first quarter of 2024, the Company recognized net loss from continuing operations of
$4.0 million $0.1 million - Net loss attributable to common shareholders for the first quarter of 2024 was
$4.0 million , or$0.16 per basic and diluted share, compared to a net loss of$8.2 million , or$0.75 per basic and diluted share, for the first quarter of 2023.
Conference Call and Webcast Information
Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Daylight Time/1:30 p.m. Pacific Daylight Time to discuss the results and provide an update on the Company's business.
Investors who wish to participate in the conference call may do so by dialing 1-800-836-8184 for North American callers, or 1-646-357-8785 (toll applies) for international callers outside of
About Talphera, Inc.
Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the
This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com.
About Niyad and nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad™, the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study has received central Institutional Review Board (IRB) approval. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets.
About the NEPHRO CRRT Study
The NEPHRO Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 10 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.
Forward-looking statements
This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "finalize," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include; Talphera's expectation of first patient enrollment in its NEPHRO CRRT registrational trial in Q2 2024; Talphera's plan to provide an estimated study completion date of the NEPHRO study after the study begins enrolling; and Talphera's expectation that the NEPHRO study will complete quickly. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not confirm any safety, potency or other product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
Selected Financial Data | ||||
(in thousands, except per share data) | ||||
(unaudited) | ||||
Three Months Ended | ||||
March 31 | ||||
2024 | 2023 | |||
Statement of Operations Data | ||||
Operating costs and expenses: | ||||
Research and development (1) | $ 1,433 | $ 1,047 | ||
Selling, general and administrative (1) | 2,804 | 4,281 | ||
Total operating costs and expenses | 4,237 | 5,328 | ||
Loss from operations | (4,237) | (5,328) | ||
Other income: | ||||
Interest expense | - | (119) | ||
Interest income and other income, net | 220 | 200 | ||
Gain on sale of future payments | 1,246 | - | ||
Change in fair value of warrant liability | (1,002) | 5,311 | ||
Non-cash interest expense on liability related to sale of future payments | (181) | - | ||
Total other income | 283 | 5,392 | ||
Net (loss) income from continuing operations | (3,954) | 64 | ||
Net loss from discontinued operations | - | (8,216) | ||
Net loss | $ (3,954) | $ (8,152) | ||
Net (loss) income per share attributable to stockholders: | ||||
Basic and diluted, continuing operations | $ (0.16) | $ - | ||
Basic and diluted, discontinued operations | $ - | $ (0.75) | ||
Basic and diluted loss per share | $ (0.16) | $ (0.75) | ||
Shares used in computing net (loss) income per share of common stock, basic and diluted | 24,722 | 10,894 | ||
(1) Includes the following non-cash stock-based compensation expense: | ||||
Research and development | $ 107 | $ 93 | ||
Selling, general and administrative | 195 | 457 | ||
Discontinued operations | - | 19 | ||
Total | $ 302 | $ 569 | ||
Selected Balance Sheet Data | |||
(in thousands) | |||
March 31, 2024 | December 31, 2023(1) | ||
(Unaudited) | |||
Cash, cash equivalents and investments | $ 18,584 | $ 9,381 | |
Total assets | 28,772 | 20,395 | |
Total liabilities | 12,438 | 6,290 | |
Total stockholders' equity | 16,334 | 14,105 | |
(1) Derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023. | |||
Reconciliation of Non-GAAP Financial Measures | |||
(Operating Expenses less stock-based compensation expense) | |||
Three Months Ended | |||
March 31 | |||
2024 | 2023 | ||
Operating expenses (GAAP): | |||
Research and development | $ 1,433 | $ 1,047 | |
Selling, general and administrative | 2,804 | 4,281 | |
Total operating expenses | 4,237 | 5,328 | |
Less stock-based compensation expense | 302 | 550 | |
Operating expenses (non-GAAP) | $ 3,935 | $ 4,778 | |
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SOURCE Talphera, Inc.
FAQ
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