Author: Ken Dropiewski

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

-Biologics License Application (BLA) for HAV™ Accepted by FDA on February 8, 2024- -BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024- -Raised approximately $43.1 million in net proceeds from public offering of common stock- -Conference call and live webcast at 8:00 a.m. ET today- DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch. “During 2023, we accomplished major goals across all of our clinical programs. In December 2023, we submitted our Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the HAV in the vascular trauma indication,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “The FDA’s acceptance of our filing in February 2024 brings us another major step closer to our goal of providing an innovative regenerative medicine product for patients suffering traumatic vascular injury. We believe the FDA’s decision to grant Priority Review reflects their recognition that many patients with severe injuries are underserved by the current standard of care. We look forward to working with the agency toward their Prescription Drug User Fee Act (PDUFA) date of August 10, 2024.” “During the year we were also pleased with the progress made in our broader HAV pipeline, including completion of enrollment of our V007 Phase 3 trial of the HAV for use in AV access for hemodialysis, presentation and publication of clinical trial results in severe peripheral artery disease (PAD), and publication of preclinical results for our small caliber HAV in a juvenile heart disease preclinical model. The coming year will be exciting, and we thank the medical professionals, patients, researchers and our employees for their contributions to the continued advancement of the HAV,” concluded Dr. Niklason. Fourth Quarter 2023 and Recent Corporate Highlights Clinical and Regulatory Updates Biologics License Application for HAV Granted Priority Review by U.S. FDA for the Vascular Trauma Indication – In February 2024, the Company announced that the FDA had accepted and granted Priority Review to its BLA seeking approval of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks in both the V005 Phase 2/3 clinical trial and the Ukraine humanitarian program.The PDUFA date, the FDA action date for their regulatory decision regarding the BLA, is August 10, 2024. The Priority Review designation is a mechanism reserved by FDA for products that, if approved, would significantly improve the treatment, diagnosis, or prevention of serious conditions. Priority Review applications have a six-month review time instead of ten months for a standard review. The Priority Review aligns with the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2023 for urgent arterial repair following extremity vascular trauma. The Priority Review is also consistent with the priority designation given by the Secretary of Defense under Public Law 115-92, which was enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel. Presentations and Publications Presentations at a Major Vascular Surgery Symposium – Two presentations were made at the VEITH Symposium, a major vascular surgery meeting, held in New York City on November 15-18, 2023. These include an expanded presentation of positive results of the V005 vascular trauma trial, with the HAV observed to have higher rates of patency and lower rates of amputation and infection as compared to historic synthetic graft benchmarks.Results of the V005 trial were presented by Charles J. Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 trial, in a podium presentation titled “Phase 2/3 Study for the Evaluation of Safety and Efficacy of HAV for Vascular Reconstruction in Patients with Limb or Life-Threatening Vascular Trauma.” Results from V005 and the Ukraine humanitarian program, with statistical comparison to historic benchmarks, were presented at a symposium titled “Vascular Trauma Repair Clinical Study Results with Humacyte Human Acellular Vessel (V005 & V017 Data)” by Dr. Moore, Dr. Fox, and Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte. Publication of Preclinical Results in Juvenile Heart Disease Study – In October 2023, a publication in the Journal of Thoracic and Cardiovascular Surgery described a preclinical study showing the potential for the investigational small-diameter HAV to treat tetralogy of Fallot, a heart condition that affects one in every 2,000 babies born each year in the United States. In the preclinical study, researchers from Nationwide Children’s Hospital (Columbus, OH) and Humacyte implanted 3.5mm diameter HAVs into a juvenile animal model of pediatric heart disease. The 3.5mm HAVs remained patent for up to six months, and evidence of HAV repopulation by host cells was observed, similar to what has been observed in human patients. In connection with the study, Humacyte produced 3.5mm vessels using the same manufacturing platform used to produce Humacyte’s 6mm HAVs that are in current clinical use. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agencies. Fourth Quarter and Full Year 2023 Financial Highlights The Company reported cash and cash equivalents of $80.4 million as of December 31, 2023. In addition, Humacyte completed two transactions in early 2024 which added to its cash balance. On March 5, 2024, the Company closed an underwritten public offering of its common stock and raised net proceeds of approximately $43.1 million. Furthermore, on March 11, 2024, the Company received $20 million in proceeds from an additional draw under its previously disclosed funding arrangement with Oberland Capital Management. Total net cash used was $69.0 million for the year ended December 31, 2023, compared to $67.7 million for the year ended December 31, 2022. Humacyte believes that its cash and cash equivalents, including net proceeds from the March offering and additional draw under the Oberland funding arrangement, will be adequate to finance operations for at least 12 months from the date of this financial report, well past the currently anticipated timelines for FDA approval of commercialization of the HAV in the vascular trauma indication. There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023. Revenue was $1.6 million for the year ended December 31, 2022, and was related to a grant supporting the development of the HAV that was completed during 2022. Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022. The 2023 increases resulted primarily from increased personnel, external services expenses and materials expenses to support expanded research and development initiatives and our clinical trials, including the completion of our V005 Phase 2/3 and V017 Ukraine Humanitarian trials for the use of the HAV in extremity vascular trauma, our BLA filing in December 2023, and expansion of clinical development of the HAV for use in AV access for hemodialysis. General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022. The slight net increases in 2023 resulted primarily from increased personnel costs, primarily driven by preparation for the planned commercial launch of the HAV in the vascular trauma indication. Other net income (expense) was net income of $1.1 million for the fourth quarter of 2023, compared to net income of $17.1 million for the fourth quarter of 2022, and was net expense of $10.7 million for the year ended December 31, 2023, compared to net income of $72.6 million for the year ended December 31, 2022. The reduction in other net income for the fourth quarter of 2023, and the increase in other net expense for the year December 31, 2023, resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $25.1 million for the fourth quarter of 2023, compared to $3.7 million for the fourth quarter of 2022, and net loss was $110.8 million for the year ended December 31, 2023, compared to $12.0 million for the year ended December 31, 2022. The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above. Conference Call and Webcast Details Title:Humacyte Fourth Quarter and Year End 2023 Financial Results and Corporate UpdateDate:Friday, March 22, 2024Time:8:00 a.m. ETConference Call Details:Toll-Free: 1- 877-704-4453International: 1-201-389-0920Conference ID #: 13744046Call meTM Feature (avoid waiting for operator):Click HereWebcast:Webcast Link – Click Here A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm HAV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans and ability to obtain marketing approval from the FDA and other regulatory authorities for the HAV and other product candidates; the outcome of the FDA’s review of our BLA seeking approval of the HAV in the vascular trauma indication; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials, including for our V007 Phase 3 clinical trial; the characteristics and performance of the HAV; our ability to manufacture HAVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; our plans and ability to commercialize the HAV and other product candidates, if approved by regulatory authorities; and our anticipated cash runway. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com Humacyte, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands except for share and per share amounts)  Three Months EndedDecember 31, Year EndedDecember 31,  2023   2022   2023   2022 Grant revenue$—  $—  $—  $1,565         Operating expenses:       Research and development 20,180   14,957   76,550   63,260 General and administrative 6,002   5,833   23,497   22,883 Total operating expenses 26,182   20,790   100,047   86,143 Loss from operations  (26,182)  (20,790)  (100,047)  (84,578)        Other income (expense), net       Change in fair value of contingent earnout liability 1,685   17,118   (10,023)  75,767 Other expense (net) (609)  (48)  (706)  (3,154)Total other income (expense), net 1,076   17,070   (10,729)  72,613 Net loss and comprehensive loss$(25,106) $(3,720) $(110,776) $(11,965)        Net loss per share, basic and diluted$(0.24) $(0.04) $(1.07) $(0.12)Weighted-average shares outstanding, basic and diluted 103,607,631   103,162,219   103,420,238   103,051,366  Humacyte, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands)  As of December 31,  2023   2022 Assets   Current assets:   Cash and cash equivalents$80,448  $149,772 Prepaid expenses and other current assets 2,830   2,329 Short-term investments —   2,107 Total current assets 83,278   154,208 Property, plant and equipment, net 26,791   30,039 Finance lease right-of-use assets, net 17,313   19,373 Other long-term assets 841   682 Total assets $128,223  $204,302     Liabilities and Stockholders’ Equity   Current liabilities:   Accounts payable$6,490  $1,595 Accrued expenses 9,340   7,108 Other current liabilities 2,613   2,306 SVB loan payable, current portion —   8,571 Total current liabilities 18,443   19,580     Revenue interest liability 38,600   — Contingent earnout liability 37,916   27,893 Finance lease obligation, net of current portion 16,293   18,853 Other long-term liabilities 3,425   712 SVB loan payable, net of current portion —   20,336 Total liabilities  114,677   87,374     Stockholders’ equity   Common stock and additional paid-in capital 550,860   543,466 Accumulated deficit (537,314)  (426,538)Total stockholders’ equity 13,546   116,928 Total liabilities and stockholders’ equity$128,223  $204,302 

TriSalus Life Sciences Announces Oral Presentations at the Upcoming 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting

DENVER–(BUSINESS WIRE)–TriSalus Life Sciences® Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, announced today that the Company will present data from recent research findings at the 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, to be held March 23-28, 2024, in Salt Lake City, Utah. TriSalus will share data on the technical feasibility and saf

Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease

MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular and peripheral disease, today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The DynamX Bioadaptor platform is a medical technology d

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Regulatory and Corporate Update

– On track to resubmit NDA for etripamil in PSVT early 2Q 2024 – Recent financing extends cash runway into 2026 – FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2 Meeting expected mid-2024 MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) —  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update. “We look forward to resubmitting our NDA imminently. With the completion of our recent financing and potential future synthetic royalty payment, we believe we are well positioned to advance etripamil through potential approval and launch in PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We’re excited to continue this positive momentum as we execute on our programs and advance etripamil.” Corporate Updates In March 2024, completed a public offering of common shares and pre-funded warrants, raising net proceeds of approximately $32.4 million. Milestone intends to use the proceeds from the Offering to continue the development of etripamil in its lead indication of paroxysmal supraventricular tachycardia (PSVT) and its subsequent indication of atrial fibrillation with a rapid ventricular rate (AFib-RVR), as well as for working capital and other general corporate purposes. Recent Program Updates Etripamil for Patients with PSVT Announced Plans to Resubmit New Drug Application (NDA) for Etripamil for PSVT in early 2Q 2024. Milestone held a Type A meeting with the FDA in February 2024 regarding steps required to resolve the items raised in the Refusal to File (RTF) letter received in December 2023. The Company is working to restructure the data sets that capture timing of reported adverse events (AEs) in the clinical etripamil studies and is reformatting certain data files to facilitate FDA’s analyses. The Company expects a standard NDA review period following resubmission of the NDA. Etripamil for Patients with AFib-RVR Phase 3 guidance received from FDA in 1Q2024 meeting. FDA reiterated prior guidance regarding the availability of a single-study supplemental New Drug Application (sNDA) pathway contingent on obtaining approval for the NDA in PSVT. FDA further concurred with respect to key study elements including powering, inclusion criteria, patient population, and statistical analyses, and offered clarification with respect to the endpoints to guide the design of the Phase 3 study. We anticipate progressing to an End of Phase 2 meeting to finalize the registrational study protocol in mid-2024.Positive Results from ReVeRA Phase 2 Study of Etripamil in AFib-RVR Presented as Featured Science at the American Heart Association (AHA) Scientific Sessions 2023 and Simultaneously Published in Circulation: Arrhythmia and Electrophysiology. In November 2023, Milestone announced positive data from the ReVeRA Phase 2 study that show that patients with AFib-RVR receiving etripamil demonstrated rapid and statistically superior ventricular rate reduction and improved symptom-relief when compared to placebo. Safety and tolerability reported in the 56-patient safety population who received etripamil was generally consistent with that observed in the Company’s extensive safety database from the PSVT program. The results were presented as a Featured Science presentation at the American Heart Association (AHA) Scientific Sessions 2023 and simultaneously published in Circulation: Arrhythmia and Electrophysiology, which can be found here. Fourth Quarter and Full Year 2023 Financial Results   As of December 31, 2023, Milestone had cash, cash equivalents, and short-term investments of $66.0 million, compared to $64.6 million as of December 31, 2022.There was no revenue recorded for the fourth quarter of 2023, compared with $3.5 million the fourth quarter of 2022. Revenue for the full year ended December 31, 2023 was $1.0 million compared to $5.0 million in the year ended December 31, 2022. Revenue in 2023 was related to a milestone payment received from Ji Xing Pharmaceuticals, under the Company’s License and Collaboration Agreement. Revenue in 2022 was related to two milestone payments received under the agreement with Ji Xing Pharmaceuticals.Research and development expense for the fourth quarter of 2023 was $5.5 million, compared with $10.6 million for the prior year period. For the full year ended December 31, 2023, research and development expense was $31.1 million, compared with $39.8 million for the prior year. The decrease year over year was primarily due to lower clinical expenses as a result of the completion of Phase 3 studies, partially offset by an increase in drug manufacturing consulting costs, drug manufacturing personnel costs and regulatory consulting costs.General and administrative expense for the fourth quarter of 2023 was $3.4 million, compared with $4.1 million for the prior year period. For the full year ended December 31, 2023, general and administrative expense was $15.9 million, compared with $15.7 million for the prior year.Commercial expense for the fourth quarter of 2023 was $5.0 million, compared with $2.6 million for the prior year period. For the full year ended December 31, 2023, commercial expense was $15.1 million, compared with $9.1 million for the prior year. The increase in commercial expense year over year was a result of additional personnel and professional costs required to expand capabilities and operations in anticipation of potential commercialization.For the fourth quarter of 2023, net loss was $13.6 million, compared to $13.2 million for the prior year period. For the full year ended December 31, 2023, Milestone’s net loss was $59.7 million, compared to $58.4 million for the prior year. For further details on the Company’s financials, refer to Form 10-K for the year ended December 31, 2023, filed with the SEC. About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About Atrial Fibrillation with Rapid Ventricular Rate An estimated five million Americans suffer from AFib, a common arrhythmia marked by an irregular, disruptive and often rapid heartbeat. The incidence of AFib is expected to grow to approximately 10 million by 2025 and up to about 12 million by 2030. A subset of patients with AFib experience episodes of abnormally high heart rate most often accompanied by palpitations, shortness of breath, dizziness, and weakness. While these episodes, known as AFib-RVR, may be treated by oral calcium channel blockers and/or beta blockers, patients frequently seek acute care in the emergency department to address symptoms. In 2016, nearly 800,000 patients were admitted to the emergency department due to AFib symptoms where treatment includes medically supervised intravenous administration of calcium channel blockers or beta blockers, or electrical cardioversion. With little available data for AFib-RVR, Milestone’s initial market research indicates that 30 to 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market of approximately three to four million patients in 2030 for etripamil in patients with AFib-RVR. About Etripamil Etripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat highly symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA, including the timing of the FDA’s potential review of the NDA, once resubmitted, and the timing of the End of Phase 2 meeting; our cash runway; our ability to receive the synthetic royalty payment; our ability to advance etripamil through approval and launch in PSVT; our ability to launch etripamil for PSVT; our intended use of proceeds from the March 2024 public offering of common shares and pre-funded warrants; our future target addressable market; and the ability of etripamil to provide health care providers with a new treatment option to enable on-demand care and patient self-management and to provide patients with active management and a greater sense of control over their condition. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether a Type A meeting will be granted and whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.                                                                                                                                                                          Milestone Pharmaceuticals Inc.Consolidated Statements of Loss(in thousands of US dollars, except share and per share data)           Years Ended    December 31,        2023     2022         Revenue  $1,000  $5,000         Operating expenses       Research and development, net of tax credits  $31,052  $39,829 General and administrative   15,932   15,718 Commercial   15,114   9,095         Loss from operations   (61,098)  (59,642)        Interest income   3,967   1,254 Interest expense   (2,554)  —         Net loss and comprehensive loss  $(59,685) $(58,388)        Weighted average number of shares and pre-funded warrants outstanding, basic and diluted    42,955,779   42,450,316         Net loss per share, basic and diluted  $(1.39) $(1.38) The accompanying notes are an integral part of these consolidated financial statements.        Milestone Pharmaceuticals Inc.Consolidated Balance Sheets(in thousands of US dollars, except share data)            December 31, 2023    December 31, 2022Assets               Current assets       Cash and cash equivalents $13,760  $7,636 Short-term investments  52,243   56,949 Research and development tax credits receivable  643   331 Prepaid expenses  3,178   6,005 Other receivables  3,208   882 Total current assets  73,032   71,803 Operating lease right-of-use assets  1,917   2,423 Property and equipment  277   257 Total assets $75,226  $74,483        Liabilities, and Shareholders’ Equity               Current liabilities        Accounts payable and accrued liabilities $6,680  $5,644 Operating lease liabilities  546   495 Total current liabilities  7,226   6,139 Operating lease liabilities, net of current portion  1,457   1,996 Senior secured convertible notes  49,772   — Total liabilities  58,455   8,135               Shareholders’ Equity       Common shares, no par value, unlimited shares authorized 33,483,111 shares issued and outstanding as of December 31, 2023, 34,286,002 shares issued and outstanding as of December 31, 2022  260,504   273,900 Pre-funded warrants – 9,577,257 issued and outstanding as of December 31, 2023 and 8,518,257 as of December 31, 2022  48,459   34,352 Additional paid-in capital  33,834   24,437 Accumulated deficit  (326,026)  (266,341)       Total shareholders’ equity   16,771   66,348        Total liabilities and shareholders’ equity  $75,226  $74,483  Contact: Kim Fox, Vice President, Communications kfox@milestonepharma.com 704-803-9295 Investor Relations Chris Calabrese ccalabrese@lifesciadvisors.com Kevin Gardner kgardner@lifesciadvisors.com

MediciNova Announces Two Abstracts regarding MN-001 (tipelukast) and MN-002 Accepted for Presentation at the 92nd EAS 2024 Congress, the Annual Meeting of the European Atherosclerosis Society

LA JOLLA, Calif., March 20, 2024 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that two abstracts entitled “STUDY PROTOCOL TO EVALUATE MN-001’S (TIPELUKAST) EFFICACY, SAFETY AND TOLERABILITY IN SUBJECTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD), HYPERTRIGLYCERIDEMIA (HTG) AND TYPE-2 DIABETES MELLITUS (T2DM)” and “MN-002, THE METABOLITE OF MN-001(TIPELUKAST) PROMOTES MACROPHAGE CHOLESTEROL EFFLUX” have been accepted and selected for poster presentation at the 92nd European Atherosclerosis Society (EAS) 2024 Congress to be held May 26-29, 2024. MediciNova’s Chief Medical Officer, Kazuko Matsuda, MD PhD MPH will present the ongoing clinical trial design and objectives, and Dr. Qi Huicheng will present the results of the research to evaluate the mechanism of action of MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001). Presentation details will be disseminated as they become available. Kazuko Matsuda, M.D. Ph.D., M.P.H., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased that the two presentations were accepted at the EAS 2024 Congress. One presentation is regarding the objectives and design of the ongoing Phase 2 clinical trial enrolling patients with Type 2 diabetes, dyslipidemia, and NAFLD. The other presentation is regarding the mechanism of action of MN-001/MN-002 in lipid metabolism, particularly the effects on cholesterol efflux capacity. This is the outcome from our research collaboration with Professor Takashi Mitsui MD PhD, and Professor Masatsune Ogura MD PhD at Juntendo University to evaluate the mechanism of action of MN-001 in lipid metabolism and metabolic syndrome”. About NAFLD, Type 2 Diabetes Mellitus, and Hypertriglyceridemia NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD. There is sufficient clinical and epidemiological evidence supporting the assertion that NAFLD is strongly associated with an increased prevalence and incidence of cardiovascular disease, T2DM, chronic kidney disease, and malignancy. The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20 – 80% of NAFLD cases. About MN-001 MN-001 (tipelukast) is a novel, orally bioavailable, small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development, and MN-001’s inhibitory effect on 5-LO and the 5-LO/LT pathway is a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, MN-001 was found to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake. About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma, Long COVID, and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT:Geoff O’BrienVice PresidentMediciNova, Inc.info@medicinova.com

Vista.ai Appoints MedTech Veteran Daniel Hawkins as Chief Executive Officer

PALO ALTO, Calif.–(BUSINESS WIRE)–VISTA.AI today announced the appointment of Daniel Hawkins as President and CEO. The company is pioneering AI-driven MRI image acquisition enabling any MRI technician to consistently produce high quality scans for complex indications quickly, efficiently and affordably. Daniel joins Vista.ai at a pivotal time following FDA clearance and confirmatory early commercialization of the company’s initial product focused on Cardiac MRI (CMR). Over time, the company p

BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024

SUNNYVALE, Calif., March 20, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will report its financial results for the year ended December 31, 2023 and provide a corporate update by conference call on Wednesday, March 27, 2024 at 4:30 PM ET. Following management’s formal remarks, there will be a question-and-answer session. Participants can register for the conference by navigating to https://dpregister.com/sreg/10187416/fbec8cfa30. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=Ya3BT5pb. A webcast replay of the call will be available approximately one hour after the end of the call through June 26, 2024 at the above links. A telephonic replay of the call will be available through April 10, 2024 and may be accessed by calling 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada) by using access code 3499879. About BioCardia®BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary Helix transendocardial biotherapeutic delivery system, as well as technology and services for the development and commercialization of partners’ therapeutic agents. For more information visit www.biocardia.com. MEDIA CONTACT:Miranda Peto, Marketing / Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@biocardia.com (650) 226-0120