공시 • Mar 25

Talphera, Inc. Announces Acceptance of Two Abstracts for Presentation At Aki & CRRT 2026

Talphera, Inc. announced the acceptance of two abstracts for presentation at the 31st Annual International Conference on Advances in Critical Care Nephrology: AKI & CRRT 2026 to be held March 29-April 2, 2026 in San Diego. The poster will highlight the key components of the NEPHRO-CRRT study design, currently enrolling patients in the registrational study. There is an unmet medical need for safe, effective, and simple-to-use regional anticoagulants for use during CRRT. Nafamostat has desirable properties and extensive user experience as a regional anticoagulant for over three decades outside of the US. The NEPHRO-CRRT is an ongoing registrational study to evaluate the safety and efficacy of nafamostat for its potential approval in the US to address this unmet need. This study characterized the pharmacokinetics of nafamostat and its effect on post-filter and systemic Activated Clotting Time (ACT) across different membrane types in a porcine model of AKI receiving CRRT. When administered pre-filter, over 95 percent of nafamostat was removed by the hemofilter, resulting in the median systemic exposures of less than 5 percent of the pre-filter exposure. There was a minimal effect on the systemic ACT when the post-filter ACT was less than 275 seconds. The NEPHRO CRRT registrational study of nafamostat is targeting a post-filter ACT of 175 to 225 seconds, which is expected to provide sufficient extracorporeal anticoagulation while minimally affecting systemic ACT. In conclusion, nafamostat has unique PK and PD properties, making it a suitable candidate for further evaluation as a regional anticoagulant in CRRT. The NEPHRO CRRT Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 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 the mean post-filter activated clotting time over 72 hours, 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. 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 is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. 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.

Seeking Alpha • Aug 18

AcelRx: The Catalogue Of Catalysts - Including A Big One That Will Do Investors Well

AcelRx's 2Q22 Earnings Release and Call provided little tangible news. However, it becomes more and more obvious that ACRX’s management is fully shifting the focus from commercial DSUVIA to launching the Syringes products and Niyad. In light of the ongoing cash burn, the prospects of this pivoting are highly dependent on the terms of the pending DSUVIA out-licensing agreements. I believe the market is underestimating the potential of the deal so that ACRX still has substantial short-term upside potential. This is my quarterly update of AcelRx Pharmaceuticals (ACRX) - on the one hand. And in addition it is my contribution to seeking Alpha's current article competition around Stocks with a Catalyst. Because frankly, I can't think of any position in my portfolio for which taking such a perspective would be a better fit. This article is structured as follows: Quick overview of ACRX' business - readers familiar with the company or my previous extended coverage may simply skip it. Discussion of the most recent developments, this time from a catalyst perspective - changing the point of view for a company long covered is generally a useful technique Discussion of the "Elephant in the Room", i.e. the one big catalyst, being the pending deal, or even deals, for the marketing rights of DSUVIA in the US (or even beyond) There will be, and has to come, as discussed below, a major deal for the company. After my last article with a Neutral rating I added to my position, because meanwhile I concluded that there still is substantial upside from a stock price of about USD 0.31 if ACRX manages to seal a decent deal. This article summarizes why I believe such deal will come and what I believe the resulting favorable valuation impact to be. Throughout the remaining discussion, EC refers to the 2q22 Earnings Call of ACRX. ACRX Business Overview ACRX is a pharmaceutical company operating in the space of supervised medical settings, i.e. hospitals, ASCs (Ambulatory Surgical Centers), and procedural suites, such as individual dental or plastic surgeons. It does not sell its products to pharmacies or drug stores. Currently, ACRX' active products are limited to sublingual sufentanil tablets (or SST). The main product is called DSUVIA and is sold in the US. It is an opioid based analgetic for use against acute moderate to severe pain. It is sold to the above mentioned supervised medical institutions (referred to as Commercial Sales by management), and also to the DoD (DoD Sales), which sponsored DSUVIA's development and is anticipated to become the largest single customer in the short-term by supplying SKOs (sets, kits, and outfits) of the US Army with DSUVIA for battlefield pain management. A detailed discussion of the features of DSUVIA, or more generally SST, can be found here. DSUVIA is approved in Europe under the name DZUVEO, and ACRX partnered with private French company Aguettant to commercialise DZUVEAU in this territory. ACRX confirmed during the EC that DZUVEOs market launch is scheduled for the third quarter of 2022. DZUVEO was sold in Europe under the name Zalviso for use through SDA (single dose applicators), but the private German commercialisation partner Grünenthal cancelled the sales agreement. Zalviso is not yet approved by the FDA for commercialisation in the US - and as discussed below, ACRX management announced during the EC that they dropped the plan to apply for approval any time soon. Further, ACRX has licensed two syringes products with Aguettant for commercialisation by ACRX in the US. These products (the Syringes) are not yet FDA approved. The limited news to report on the progress of the approval process are discussed below. The syringes provide ephedrine and phenylephrine, substances used to regulate severe side effects that come with analgesia, i.e. products like DSUVIA. Readers more interested in these substances and Aguettant find a detailed discussion here. Finally, in January 2022 ACRX completed the acquisition of private Lowell Therapeutics, Inc. (hereafter: Lowell). Details of the transaction are discussed here. Lowell developed a product called Niyad, a Nafamostat-based regional anticoagulant for dialysis circuit during continuous renal replacement therapy for acute kidney injury patients in the hospital. Niyad is not approved by the FDA in the US. Catalysts for Cynics I am a Mathematician and my profession is notorious for taking the formal way. So, here we go by first recalling the definition of a catalyst, according to Wikipedia: Catalysis is the process of increasing the rate of a chemical reaction by adding a substance known as a catalyst. Now, combining this definition with the 10-chart for ACRX stock printed below may cause cynics to state that there is actually no need for acceleration of what is going on with the company: Seeking Alpha The reasons for this historic development are easy to list: DSUVIA, or SST, to be more precise, were viewed by management, including Dr. Pamela Palmer, Chief Medical Officer as a game-change in the treatment of moderate to severe acute pain. However, since the final approval in late 2018 sales have lagged any management forecast by orders of magnitude. I have discussed candidates for reasons in depth in this article - they range from what was most likely a mis-focus initially on Emergency Room use all the way to COVID-19, which absorbed hospital capacity by requiring treatment of unprecedented numbers of people suffering from a lethal and highly contagious lung disease and left too little space for changing the standard of care in pain management. The result is obvious: High cash burn, ongoing dilution and fading investor trust. To be very clear: Per the end of 2q22, ACRX had USD 27 million of cash, USD 10 million of debt due until May 2023 and a quarterly cash burn of some USD 8 million. None of the resulting obvious issues is needed at a higher dose or at an increased rate. On the other hand, it seems that investors have priced in most of the essentially bad news that came in recently: First, ACRX received its second and final letter from NASDAQ, clarifying that ACRX stock will be delisted if, very informally, the stock price does not go back up to USD 1.00 at least. As a result, ACRX started to prepare investors for an upcoming reverse stock-split by announcing a dedicated special shareholder meeting for September 23, 2022. In theory, the number of shares outstanding should not affect the equity's market capitalization. However, since such reverse stock split is usually the result of poor returns, which are often the result of poor operational performance, it frequently accelerates the decline in stock price - thereby essentially becoming a catalyst. I usually do not comment short-term market movements, or the lack thereof, but is seems plausible that anyone saw this reverse split coming, so market reaction wasn't significant - at least in comparison to other movements that I will discuss below. In any case, most likely, we will witness a reverse stock split sometime in October / November. For the sake of completeness, it is necessary to mention one piece of information that ACRX management shared during the EC. The company stopped all efforts for the Zalviso US-approval process with the FDA. A while back, this may have triggered strong investor reaction, but I guess this makes sense: As I have discussed before, the main reason is that most likely hospitals want to get sound experience with SST before handing it out to patients (in supervised medical settings, that is) through a dispensing device. Bottom-line is that a lot went wrong during the last 3-4 years, so that certain unfavorable news just don't do the catalyst job. Accordingly, from here on I will focus on catalysts with upside potential. Slow and Lame Catalysts There are other things going on at ACRX that may appear huge, but did not trigger severe reactions. Zalviso Returning to Zalviso for example: It was fully approved in the EU, and ACRX sold a massive amount of expected Royalty payments it expected to receive to a third party (who, too, had an optimistic view on the market potential). The deal was non-recourse, i.e. without royalty payments there was no liability by ACRX to repay the financing. The claim changed hands a couple of times, and the latest owner agreed with ACRX to bury the whole story, or in more formal terms per ACRX' CFO's words during the EC: $84.1 million gain related to the extinguishment of the royalty monetization agreement that was held by SWK. This termination eliminates any further contractual obligation associated with the royalty monetization agreement and eliminates the corresponding liability previously recorded on our balance sheet. A USD 80 million gain for a company with a market cap of some USD 40 million - this might kick-off fireworks for other companies, but was a nil event instead for ACRX, since this was obvious from the financial reporting in the past (sometimes markets do digest information efficiently). And there is probably other near-term news to come that will not change an awful lot for investors in the short-term, but does represent milestones that I expect to contribute positively over the long term: DZUVEO Launch First, there is the formal DZUVEO launch in Europe by Aguettant, expected during the remainder of 3q22. At the EC, ACRX management reported first deliveries of DSUVIA to Europe, so things are developing. It goes without saying that we still need to wait for indications of the level of commercial adoption of DZUVEO in Europe. COVID is not gone by any means, and the slow adoption of DSUVIA in the US will not be of big help with marketing overseas. On the other hand, there were no real-world studies published at the time of the DSUVIA US-launch demonstrating the use cases for SST. And by now, Aguettant know which surgical specialties have been adopting easily in the US, so they know where to start themselves. Plus, things are different in Europe with regards to opioid use: We did not suffer from ruthless pharma companies pushing medication into the hands of laymen, who had no idea - and where actively mislead - about the addictiveness of these substances. On the downside from a pharma company's view, drug margins are much lower in Europe. Bottom-line is that we need to wait for another couple of quarters before we get a clear idea of the earnings potential from this market. ACRX Pivot Over the last 12 months, ACRX added two late stage assets for the US market: the Syringes and Niyad / Nafamostat. As I will discuss below, these are most likely not mere additions to the asset portfolio, but may in fact be the actual future of ACRX. Per management commentary during the EC: With two planned NDA filings in 2022, we expect our prefilled syringes will be our next FDA-approved products that a commercial launch could occur as soon as next year And (emphasis added): (…) we've prioritized our focus on Niyad, our first Nafamostat product, which is being developed for use in the U.S. as an anticoagulant for extracorporeal circuits, such as for use during dialysis. The entire EC made clear that ACRX is moving away from DSUVIA: No more REMS certification or FA (Formulary Approval) numbers were given, despite this being a main KPI historically. DSUVIA sales increased a "meagre" 18% quarter-over-quarter, but this wasn't anyone's focus anymore (including analysts) The DSUVIA sales efforts at ACRX are left with a team of less than ten purely "virtual" sales people solely addressing procedural suites (as opposed to hospitals and ASCs, the initial focus) I continue to assume that ACRX will retain the relationship with the DoD, given the long history of collaboration between the two parties. And comments made during the call seem to indicate that the procedural suites business and / or certain surgical specialties will stay with ACRX, too, see e.g. this comment during the EC (with "them" being maxillofacial and plastics clinics groups): I think it's important that we've been approached by them (…). (….) they would have a significant impact on our sales moving forward without quoting you a number. They would be our largest accounts. It is good to see for many reasons that there is interest for DSUVIA, and that healthcare providers learn of this through word-of-mouth, especially in the plastics specialty. This will help with the DZUVEO launch and it should also help with negotiating the Big One, discussed below. In any case, we can already observe how management attention is turned away from significant parts of the DSUVIA market. For the Syringes and Niyad, the imminent tasks are all about FDA approvals. I have summarized the road ahead before for both Syringes and Niyad. If things go according to management plan, the first revenue may come in late 2023. Say that is 6 quarters from now, this makes for a cash need of some USD 50 million (being 6 * 8). Plus, there will be external cost for the Niyad approval process, as well as the USD 10 million of debt to repay. The grand total is a cash need of some USD 80 million, of which ACRX held some USD 27 million per the end of 2q22, which I will consider additional safety. We will come back to this (ballpark) number soon. Small Catalysts That was many words about things that did not cause or most likely will not cause a huge effect on ACRX' share price in the short-term. Now it is time to look at those events that may in fact turn the fate at a faster pace. Before addressing the one big trigger that should be on any investors' mind, let's look first at some 2nd tier, but still relevant items. DoD Order (Non-commercial Business) ACRX shareholders have been waiting for years to hear about a huge order from the DoD. As a quick reminder, DSUVIA development was funded to a substantial degree by the DoD, supporting its search for appropriate battlefield pain management. It took a while, but by now the US Army went through virtually all formal steps (including the often quoted Milestone C meeting) required for deploying the SKOs (Sets, Kits and Outfits) of their troops with DSUVIA. ACRX management's estimate for the revenue from initial deployment of the SKOs to all branches of the military is USD 30 million, but we haven't seen purchases anywhere near that level to-date. Apparently, the DoD is a special customer, and there is little ACRX management can do to make them move faster. There were some smaller orders in almost any of the previous quarters - representing the non-commercial share of Revenue as reported by ACRX - most probably for studies conducted by the Army.

Pharmaceuticals 이익 성장	14.4%
매출 성장률	63.2%
향후 자기자본이익률	n/a
애널리스트 커버리지	Low
마지막 업데이트	14 May 2026

날짜	매출	이익	자유현금흐름	영업현금흐름	평균 애널리스트 수
12/31/2028	11	-13	N/A	N/A	2
12/31/2027	N/A	-20	N/A	N/A	2
12/31/2026	N/A	-18	N/A	N/A	2
3/31/2026	0	-14	-11	-11	N/A
12/31/2025	0	-14	-11	-11	N/A
9/30/2025	0	-12	-11	-11	N/A
6/30/2025	0	-11	-12	-12	N/A
3/31/2025	0	-12	-13	-13	N/A
12/31/2024	N/A	-13	-13	-13	N/A
9/30/2024	0	-16	-14	-14	N/A
6/30/2024	0	-14	-14	-14	N/A
3/31/2024	1	-14	-15	-15	N/A
12/31/2023	1	-10	-18	-17	N/A
9/30/2023	0	-11	-19	-19	N/A
6/30/2023	0	-14	-22	-21	N/A
3/31/2023	N/A	58	-25	-25	N/A
12/31/2022	N/A	54	-29	-28	N/A
9/30/2022	-2	69	-31	-31	N/A
6/30/2022	-1	65	-30	-30	N/A
3/31/2022	2	-31	-31	-29	N/A
12/31/2021	0	-17	-32	-30	N/A
9/30/2021	4	-36	-32	-28	N/A
6/30/2021	3	-37	-36	-33	N/A
3/31/2021	6	-33	-36	-34	N/A
12/31/2020	5	-40	-40	-39	N/A
9/30/2020	5	-46	-47	-46	N/A
6/30/2020	4	-50	-52	-50	N/A
3/31/2020	2	-55	-55	-52	N/A
12/31/2019	2	-53	N/A	-51	N/A
9/30/2019	2	-51	N/A	-46	N/A
6/30/2019	2	-51	N/A	-41	N/A
3/31/2019	2	-49	N/A	-35	N/A
12/31/2018	2	-47	N/A	-29	N/A
9/30/2018	2	-44	N/A	-27	N/A
6/30/2018	3	-45	N/A	-27	N/A
3/31/2018	5	-48	N/A	-30	N/A
12/31/2017	8	-52	N/A	-30	N/A
9/30/2017	14	-51	N/A	-33	N/A
6/30/2017	16	-50	N/A	-31	N/A
3/31/2017	17	-48	N/A	-31	N/A
12/31/2016	17	-43	N/A	-29	N/A
9/30/2016	13	-44	N/A	-12	N/A
6/30/2016	25	-28	N/A	-13	N/A
3/31/2016	22	-25	N/A	-15	N/A
12/31/2015	19	-24	N/A	-20	N/A
9/30/2015	18	-28	N/A	-36	N/A
6/30/2015	7	-32	N/A	-36	N/A

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/05/21 21:19
종가	2026/05/21 00:00
수익	2026/03/31
연간 수익	2025/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
James Molloy	Alliance Global Partners
David Buck	B. Riley Securities, Inc.
Andrew D'Silva	B. Riley Securities, Inc.

Talphera 향후 성장

Future 기준 점검 0/6

핵심 정보

최근 향후 성장 업데이트

No longer forecast to breakeven

Consensus EPS estimates upgraded to US$1.16 loss, revenue downgraded

Consensus forecasts updated

Price target decreased to US$4.00

Consensus forecasts updated

Consensus forecasts updated

Recent updates

Talphera, Inc. to Report Q1, 2026 Results on May 13, 2026

Talphera, Inc., Annual General Meeting, Jun 22, 2026

No longer forecast to breakeven

Talphera, Inc. Announces Acceptance of Two Abstracts for Presentation At Aki & CRRT 2026

Talphera, Inc. Receives Notice of Non-Compliance with Minimum Bid Price Requirement from Nasdaq

Talphera Announces 50% Enrollment Milestone in Ongoing NEPHRO-CRRT Registrational Trial

Talphera, Inc. to Report Q3, 2025 Results on Nov 12, 2025

Talphera Announces Appointment of Joseph Todisco to Its Board of Directors

New major risk - Shareholder dilution

Talphera, Inc. announced that it expects to receive $29 million in funding from CorMedix Inc., Nantahala Capital Management, LLC, Rosalind Advisors, Inc. and other investors

New minor risk - Share price stability

Talphera, Inc., Annual General Meeting, Oct 23, 2025

New minor risk - Profitability

Talphera, Inc. to Report Q2, 2025 Results on Aug 14, 2025

New major risk - Financial position

Insufficient new directors

Talphera, Inc. to Report Q1, 2025 Results on May 14, 2025

Talphera, Inc. announced that it expects to receive $14.775 million in funding from Nantahala Capital Management, LLC, Rosalind Advisors, Inc.

Talphera, Inc. Announces Agreement with the FDA to Reduce the NEPHRO CRRT Study Size to 70 Patients from 166

Talphera, Inc. to Report Q4, 2024 Results on Mar 31, 2025

Talphera Announces Agreement with the FDA for Prior Approval Supplement Review to Reduce the Number of Patients in the NEPHRO CRRT Study

Talphera Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price Requirement

Talphera Receives a Written Notice from the Listing Qualifications Staff of the Nasdaq Stock Market

Talphera, Inc. to Report Q3, 2024 Results on Nov 13, 2024

Talphera, Inc. Announces Management Changes

Talphera, Inc. to Report Q2, 2024 Results on Aug 14, 2024

Talphera, Inc. Appoints Dr. Shakil Aslam as Chief Development Officer, Effective May 20, 2024

Talphera, Inc. to Report Q1, 2024 Results on May 14, 2024

Talphera, Inc., Annual General Meeting, Jun 24, 2024

Talphera, Inc. to Report Q4, 2023 Results on Mar 06, 2024

New major risk - Share price stability

Talphera, Inc. Appoints Abhinav Jain to Serve as a Class II Director

Talphera, Inc.(NasdaqGM:TLPH) dropped from NASDAQ Composite Index

Talphera Expects to Initiate the Registrational Study of Niyad

New major risk - Financial position

Consensus EPS estimates upgraded to US$1.16 loss, revenue downgraded

AcelRx Pharmaceuticals, Inc. to Report Q3, 2023 Results on Nov 08, 2023

AcelRx Pharmaceuticals Receives Non-Compliance Notice From Nasdaq

AcelRx Pharmaceuticals, Inc. Receives IDE Approval for Niyad and Advances to A Single Registration Study

AcelRx Pharmaceuticals, Inc., Annual General Meeting, Oct 10, 2023

New major risk - Share price stability

Second quarter 2023 earnings: EPS and revenues exceed analyst expectations

AcelRx Pharmaceuticals, Inc. to Report Q2, 2023 Results on Aug 10, 2023

New major risk - Shareholder dilution

Acelrx Pharmaceuticals Inc. Regains Compliance with Nasdaq Minimum Bid Price Rule

First quarter 2023 earnings released: EPS: US$0.006 (vs US$1.19 loss in 1Q 2022)

Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

Consensus forecasts updated

Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

Price target decreased to US$4.00

Consensus forecasts updated

Consensus forecasts updated

AcelRx: The Catalogue Of Catalysts - Including A Big One That Will Do Investors Well

Second quarter 2022 earnings: EPS and revenues exceed analyst expectations

AcelRx Pharmaceuticals: Finally, Plan B

Consensus revenue estimates fall by 16%

First quarter 2022 earnings: EPS in line with expectations, revenues disappoint

Price target decreased to US$4.00

Consensus forecasts updated

AcelRx Pharmaceuticals: Making Sense Of The Q4 Numbers

Full year 2021 earnings: EPS and revenues miss analyst expectations

AcelRx Pharmaceuticals: The Fog Is Getting Thicker

AcelRx: Battered And Bruised But Ready For Recovery In 2022

Consensus revenue estimates fall to US$4.66m

No longer forecast to breakeven

Price target decreased to US$4.25

Third quarter 2021 earnings released: US$0.07 loss per share (vs US$0.10 loss in 3Q 2020)

AcelRx Pharmaceuticals: Is Wayne Gretzky Right Or The Puck?

Second quarter 2021 earnings released: US$0.083 loss per share (vs US$0.082 loss in 2Q 2020)