Market Newsdesk

Tegoprubart used as a key component of immunosuppression regimen in the second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital

Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine

Topline results from Phase 2 BESTOW trial of tegoprubart in kidney transplantation expected in fourth quarter of 2025

Proceeds from oversubscribed $85 million underwritten offering extend cash runway to end of 2026

IRVINE, Calif., March 20, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2024 operating and financial results and reviewed recent business highlights.

“We have recently made great strides in expanding our role in bringing new options in organ transplantation to patients. Tegoprubart was a cornerstone immunosuppression component in recent historic procedures including kidney xenotransplant and islet transplants in patients with type 1 diabetes,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The results from these landmark studies together with the encouraging allograft kidney transplant clinical data we have shared continue to reinforce tegoprubart’s broad potential to protect transplanted organs and cells, regardless of the transplant type and the organ source. We are entering 2025 from a position of balance sheet strength and we are on track to deliver on multiple key milestones in the coming months, including topline results from our Phase 2 BESTOW trial in the fourth quarter of 2025.”

Fourth Quarter 2024 and Recent Business Highlights

• Announced the use of tegoprubart as a lead component of the immunosuppression treatment regimen following the second transplant of a genetically modified pig kidney into a human in a study conducted at Massachusetts General Hospital. Following the successful transplant on January 25, 2025, the patient was discharged from the hospital without need for continued treatment with dialysis for the first time in over two years.
• Reported positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first in human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard for care for prevention of transplant rejection.
• Completed an oversubscribed, underwritten offering of common stock and pre-funded warrants for total gross proceeds of $85.0 million and net proceeds of approximately $79.5 million after deducting underwriting discounts, commissions, and offering expenses. The offering, which priced at a premium, included participation from both new and existing investors.

Anticipated Upcoming Milestones

• Summer 2025: Report updated interim clinical data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients.
• 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
• 2025: Report updated interim clinical data from the investigator-led clinical trial with UChicago Medicine for pancreatic islet transplantation in subjects with type 1 diabetes.

Fourth Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments
totaled $140.2 million as of December 31, 2024 compared to $78.2 million at September 30, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.

Research and development (R&D) expenses
for the fourth quarter of 2024 were $17.9 million, including $2.7 million of non-cash stock-based compensation expense, compared to $7.1 million, including $0.3 million of non-cash stock-based compensation expense, for the comparable period in 2023.

General and administrative expenses
for the fourth quarter of 2024 were $6.8 million, including $3.9 million of non-cash stock-based compensation expense, compared to $3.3 million, including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2023.

Net loss
for the fourth quarter of 2024 was $44.6 million, or $0.64 per basic share, compared with a net loss of $30.1 million, or $1.00 per basic share, for the comparable period in 2023. Both periods included a non-cash loss from changes in the fair value of warrant liabilities, totaling $20.9 million in 2024 and $20.5 million in 2023.

Full Year 2024 Financial Results

Research and development (R&D) expenses
for the year ended December 31, 2024 were $52.0 million, including $4.3 million of non-cash stock-based compensation expense, compared to $30.3 million, including $1.5 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b, Phase 2 BESTOW and Phase 2 open-label extension trials for kidney transplantation, an increase in manufacturing costs for drug substance and drug product clinical trial supply, an increase in stock-based compensation expense and employee compensation and benefits related to increased headcount.

General and administrative expenses
for the year ended December 31, 2024 were $18.6 million, including $8.8 million of non-cash stock-based compensation expense, compared to $12.7 million, including $5.0 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by an increase in stock-based compensation expense, professional services and employee compensation and benefits.

Net loss
for the year ended December 31, 2024 was $36.2 million, or $0.75 per basic share, compared with a net loss of $116.5 million, or $4.73 per basic share, in 2023. The 2024 net loss included a non-cash gain of $30.9 million from changes in the fair value of warrant liabilities, whereas the 2023 net loss included a non-cash loss of $76.2 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, the company would have recorded a net loss of $67.1 million for the year ended December 31, 2024 and a net loss of $40.3 million for the year ended December 31, 2023.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

ELEDON PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data)
	December 31,
	2024				2023
ASSETS
Current assets:
Cash and cash equivalents	$	20,549			$	4,612
Short-term investments		119,629				46,490
Prepaid expenses and other current assets		3,552				5,027
Total current assets		143,730				56,129
Operating lease right-of-use asset, net		926				365
In-process research and development		32,386				32,386
Other assets		363				186
Total assets	$	177,405			$	89,066
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	5,833			$	967
Current operating lease liability		314				383
Accrued expenses and other liabilities		5,430				2,545
Total current liabilities		11,577				3,895
Deferred tax liability		2,183				1,752
Non-current operating lease liability		640				—
Warrant liabilities		44,865				76,211
Total liabilities		59,265				81,858
Commitments and contingencies		—				—
Stockholders’ equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized at December 31, 2024 and 2023:
Series X1 non-voting convertible preferred stock, $0.001 par value, 515,000 shares designated; 110,086 shares issued and outstanding at December 31, 2024 and 2023		—				—
Series X non-voting convertible preferred stock, $0.001 par value, 10,000 shares designated; 4,422 shares issued and outstanding at December 31, 2024 and 2023		—				—
Common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2024 and 2023; 59,789,275 and 24,213,130 shares issued and outstanding at December 31, 2024 and 2023, respectively		60				24
Additional paid-in capital		473,640				326,586
Accumulated other comprehensive income		26				—
Accumulated deficit		(355,586	)			(319,402	)
Total stockholders’ equity		118,140				7,208
Total liabilities and stockholders’ equity	$	177,405			$	89,066

ELEDON PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data)
	Year Ended December 31,
	2024				2023
Operating expenses
Research and development	$	51,964			$	30,312
General and administrative		18,613				12,688
Total operating expenses		70,577				43,000
Other income, net		3,924				2,674
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds		30,900				(76,211	)
Loss before income taxes		(35,753	)			(116,537	)
Provision for income taxes		(431	)			—
Net loss and comprehensive loss	$	(36,184	)		$	(116,537	)
Net loss per share, basic and diluted	$	(0.75	)		$	(4.73	)
Weighted-average common shares outstanding, basic and diluted		48,543,787				24,619,197

Erick J. Lucera to Step Down as CFO to pursue another opportunity

Senior Vice President of Finance Amy Parison Appointed CFO

CAMBRIDGE, Mass., March 20, 2025 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company, today announced Chief Financial Officer Erick J. Lucera is stepping down to pursue an external opportunity, effective March 28, 2025. Current Senior Vice President of Finance Amy Parison will succeed Mr. Lucera as Chief Financial Officer.

“We are thrilled to promote Amy to the executive leadership team as our new CFO. Amy joined Editas two and a half years ago as our head of Finance, working closely with the CFO. Her track record of financial decision-making, accounting acumen, and team leadership abilities make her the natural choice to succeed Erick as Editas’ CFO,” said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer.

Dr. O’Neill continued, “On behalf of the entire company, I would like to thank Erick for his contributions to Editas, including positioning Editas financially to ensure our ability to meet our goals, and his dedication to talent development. Under his leadership, Amy honed the financial and leadership skills necessary to best position Editas for success as we pursue our goal of delivering life-changing medicines to patients with previously untreatable or undertreated diseases. We wish him the best of luck in his new venture.”

“I am honored and excited for the opportunity to transition to CFO at this pivotal time for Editas, as a fully in vivo gene editing company. I am confident I can leverage my prior experience and my deep knowledge of Editas to continue our focus on developing innovative in vivo medicines for people living with serious diseases while driving shareholder value. I look forward to working with Gilmore, the board of directors, and the entire team at Editas Medicine in my new role,” said Amy Parison, Senior Vice President and Chief Financial Officer, Editas Medicine.

Mr. Lucera added, “Being a part of Editas Medicine’s journey, helping transition the company towards its goal, and working to bring in capital to support that vision has been an honor. And, as a big believer in developing the team, I look forward to seeing Amy continue to grow and have success as Editas’ new CFO.”

Ms. Parison has more than 18 years of financial, accounting, and business development experience in life sciences. During her time at Editas, she has served in multiple roles of increasing responsibilities including Senior Vice President, Finance, and Vice President and Corporate Controller. In partnership with the ELT, she worked on equity financings, licensing transactions and royalty monetization. Prior to Editas, Ms. Parison served as Corporate Controller of Rubius Therapeutics where she led the accounting team following the Company’s IPO, building critical business and financial processes. Prior to Rubius, she was at Vertex Pharmaceuticals, where she held several roles of increasing responsibility within the accounting and finance teams and supported forecasting, budgeting, and business development. She started her career with PricewaterhouseCoopers, LLP. Ms. Parison holds a BS and a Master of Accounting, both from Babson College.

About
 Editas Medicine

As a pioneering gene editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of in vivo medicines for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision in vivo gene editing medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute’s Cas12a patent estate and Broad Institute and Harvard University’s Cas9 patent estates for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8a363292-5cf0-46ce-a4ba-5efcc89740a6

Media and Investor Contact:
[email protected]

Initiated Phase 1 clinical trial evaluating its second-generation oral norovirus vaccine constructs with
topline data expected as early as mid-2025

Continues per protocol follow-up for the COVID-19 Phase 2b 400-person sentinel cohort

Cash, cash equivalents and investments of $51.7 million as of December 31, 2024 provides runway through multiple development milestones and into the fourth quarter of 2025

Conference call today at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today announced its business update and financial results for the full year 2024.

“Since our founding, Vaxart has been on a mission to transform global health with the goal of pioneering oral pill vaccines that can provide protection against common viral diseases safely and effectively,” said Steven Lo, Chief Executive Officer of Vaxart. “Developing a safe vaccine that improves convenience and reduces the risk of illness or death compared to existing options, or creates a solution where no vaccine or treatment exists, is crucial for bolstering U.S. and global public health.”

“We are making important progress on our mission by executing on our key milestones, highlighted by the initiation of our Phase 1 norovirus trial evaluating our second-generation oral vaccine candidate. We believe our second-generation candidate may be more potent than our first-generation candidate, which already demonstrated a favorable safety profile in multiple clinical trials, showed protection in a human challenge model, and elicited mucosal and systemic immunity in older adults. At the same time, we are continuing our efforts with the per protocol follow up for the 400-person sentinel cohort from our COVID-19 Phase 2b trial, and will further update on the BARDA award as events warrant,” concluded Mr. Lo.

Recent Business Highlights

Norovirus Vaccine Developments

• In March 2025, Vaxart initiated its Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The study will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study, with topline data expected as early as mid-2025.
  • If the Phase 1 trial is successful, the next step, pending a partnership or other funding, would be to conduct a Phase 2b safety and immunogenicity study that could potentially begin as early as the second half of 2025 followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.
• In March 2025, Science Translational Medicine published the complete data from Vaxart’s Phase 1b trial of its first-generation oral pill norovirus vaccine candidate in elderly adults (55-80 years).
  • Data from this study demonstrated strong and durable antibody responses and induction of norovirus-specific antibody and T cell responses, supporting the immunogenicity of the vaccine candidate in a patient population that often has age-related reductions in immune responses to injected vaccines.

COVID-19 Vaccine Developments

• In December 2024, Vaxart announced the 400-person sentinel cohort of the Phase 2b trial evaluating its COVID-19 vaccine candidate head-to-head against an approved mRNA comparator completed enrollment. Participants are monitored for up to 12 months post-vaccination to assess safety, immunogenicity, and efficacy for the sentinel cohort.
  • In January 2025, an independent Data Safety Monitoring Board (DSMB) recommended the study to proceed without modifications based on initial safety assessment the sentinel cohort’s 30-day data.
• On February 21, 2025, Vaxart received an order from Advanced Technology International on behalf of the U.S. government directing that it stop work on all its efforts on the COVID-19 Phase 2b trial, with the exception that Vaxart may continue work associated with the per protocol follow-up for the 400-person cohort. Within 90 days of the order, the stop work order will either be canceled, extended, or work on this project will be terminated.

Influenza Program Developments

• Vaxart continues to advance its avian influenza program. Vaxart previously published data demonstrating protection in a preclinical model against avian influenza after oral immunization (Clin Vaccine Immunol 2013). Vaxart recently created a new avian influenza vaccine candidate to cover the latest clade 2.3.4.4b. Vaxart is in the process of conducting several preclinical studies to evaluate the new construct and preparing to manufacture it for clinical use. Vaxart intends to publish the results of the preclinical studies when complete.

Corporate Update

• In January 2025, Vaxart appointed Kevin Finney to Vaxart’s Board of Directors. Mr. Finney is a seasoned healthcare executive and experienced board member who brings decades of industry leadership experience and operational expertise.

Financial Results for the Full Year Ended December 31, 2024

• Cash, cash equivalents and investments totaled $51.7 million as of December 31, 2024. Currently, Vaxart anticipates cash runway into the fourth quarter of 2025. After receiving the February 2025 stop work order related to the COVID Phase 2b trial, Vaxart implemented a restructuring plan that led to an approximately 10% reduction of Vaxart’s workforce on a full-time equivalent basis.
• Vaxart reported a net loss of $66.9 million for the full year 2024, compared to $82.5 million for the full year 2023. Net loss per share for 2024 was $0.33, compared to a net loss of $0.57 per share for 2023.
• Revenue for the full year 2024 was $28.7 million, compared to $7.4 million for 2023. Revenue in 2024 was primarily from government contracts related to the BARDA contracts awarded in January and June 2024. Revenue in 2023 was primarily from revenue recognized for work performed under Vaxart’s grant from the Bill & Melinda Gates Foundation and non-cash royalty revenue from increased sales of Inavir in Japan.
• Research and development expenses were $74.2 million for 2024, compared to $68.1 million for 2023. The increase is primarily due to increases in clinical trial expenses related to Vaxart’s COVID-19 vaccine candidate, an increase in manufacturing and preclinical expenses and facilities expenses, partially offset by a decrease in clinical trial expenses related to Vaxart’s norovirus vaccine candidate and a decrease in stock-based compensation expense and personnel-related costs.
• General and administrative expenses were $20.8 million for 2024, compared to $22.6 million for 2023. The decrease is primarily due to a decrease in personnel-related costs, including stock-based compensation expenses, and directors’ and officers’ insurance costs, offset by increases in severance costs, recruiting costs and other professional fees.

Conference Call

The Vaxart senior management team will host a conference call to discuss the business update and financial results for the full year 2024 today, beginning at 4:30 p.m. ET.

The conference call can be accessed using the following information:

Webcast: Click here 
Date: Thursday, March 20, 2025 – 4:30 p.m. ET 
Domestic: (877) 407-0832 
International: (201) 689-8433 
Conference ID: 13751819 

Investors may submit written questions in advance of the conference call to [email protected].

A replay of the webcast will be available for 30 days on Vaxart’s website at www.vaxart.com following the conclusion of the event.

About Vaxart

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart’s expectations regarding clinical results and trial data; and Vaxart’s expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; that the stop work order discussed above may result in further work on the COVID-19 Phase 2b trial being terminated; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contact

Vaxart Media and Investor Relations:
Matt Steinberg
FINN Partners
[email protected]
(646) 871-8481

Vaxart, Inc.
Condensed Consolidated Balance Sheets
		December 31,			December 31,
		2024			2023
		(Unaudited)			(1)
		(in thousands)
Assets
Cash and cash equivalents		$	25,229		$	34,755
Short-term investments			26,494			4,958
Accounts receivable			5,761			3,008
Unbilled receivable from government contracts			6,208			–
Prepaid expenses and other assets			5,407			3,741
Property and equipment, net			8,705			11,731
Prepaid clinical services, long-term			60,116			–
Right-of-use assets, net			20,404			24,840
Intangible assets, net			3,557			4,289
Goodwill			4,508			4,508
Total assets		$	166,389		$	91,830
Liabilities and stockholders’ equity
Accounts payable		$	6,963		$	1,584
Deferred government revenue			65,400			–
Accrued and other liabilities			11,817			5,927
Operating lease liability			17,526			20,088
Liability related to sale of future royalties			5,758			6,426
Total liabilities			107,464			34,025
Stockholders’ equity			58,925			57,805
Total liabilities and stockholders’ equity		$	166,389		$	91,830
(1)  Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2023, included on the Form 10-K filed with the Securities and Exchange Commission on March 14, 2024.

Vaxart, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
					Year Ended December 31,
					2024				2023
					(Unaudited)				(1 )
					(in thousands, except share and per share amounts)
Revenue					$	28,700			$	7,379
Operating expenses:
Research and development						74,213				68,142
General and administrative						20,780				22,584
Total operating expenses						94,993				90,726
Operating loss						(66,293	)			(83,347	)
Other (expense) income, net						(395	)			1,143
Loss before income taxes						(66,688	)			(82,204	)
Provision for income taxes						260				261
Net loss					$	(66,948	)		$	(82,465	)
Net loss per share, basic and diluted					$	(0.33	)		$	(0.57	)
Shares used in computing net loss per share, basic and diluted						202,137,531				144,819,781
(1)  Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2023, included on the Form 10-K filed with the Securities and Exchange Commission on March 14, 2024.

This press release was published by a CLEAR® Verified individual.

• TX45 Phase 1b trial interim analysis demonstrated meaningful improvements in both left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH-HFpEF”)
• Positive TX45 Phase 1b interim results support endpoints and patient population in ongoing APEX Phase 2 trial, with topline results expected in 2026
• TX45 Phase 1b Part B trial enrolled its first subject with Heart Failure with reduced Ejection Fraction (“HFrEF”) in March 2025
• Cash and cash equivalents of $141.2 million as of December 31, 2024 and February 2025 private placement gross proceeds of approximately $185.0 million, together expected to provide a cash runway into Q4’28

WATERTOWN, Mass., March 20, 2025 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”), today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided an overview of recent business highlights.

“2024 was an important year for Tectonic as we transitioned to a public company, and 2025 is already off to an excellent start,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “We are very pleased to have recently reported positive interim results from our ongoing Phase 1b trial of TX45, which we believe supports the endpoints and patient population included in our ongoing APEX Phase 2 trial. We look forward to presenting detailed results at an upcoming medical meeting as well as continuing to advance both the APEX Phase 2 trial and Part B of the Phase 1b trial.”

Recent Business Highlights

• Positive TX45 Phase 1b Part A Interim Trial Results
  : In January 2025, Tectonic announced positive interim results from Part A of the Phase 1b trial of TX45 in patients with Group 2 pulmonary hypertension in HFpEF. Results demonstrated that TX45 achieved 17.9% reduction in Pulmonary Capillary Wedge Pressure (“PCWP”) in the total study population of PH-HFpEF and >30% reduction in Pulmonary Vascular Resistance (“PVR”) in Combined pre- and post-capillary PH (“CpcPH”), a subpopulation with more severe disease. In addition, results demonstrated that TX45 achieved 17.4% improvement in Cardiac Output in the total study population of PH-HFpEF. Full results from the Phase 1b Part A trial are planned to be presented at a future medical meeting this year.
• Completed Approximately $185.0 Million Private Placement: In February 2025, Tectonic entered into a securities purchase agreement for a private investment in public equity financing (“PIPE”) that resulted in gross proceeds of approximately $185.0 million.
• Hosted Key Opinion Leader (KOL) Webinar: In December 2024, Tectonic hosted a KOL webinar featuring John R. Teerlink, MD, FHFSA (University of California San Francisco) and Raymond L. Benza, MD, FACC, FAHA, FACP (Icahn School of Medicine at Mount Sinai), who discussed the unmet medical need and current treatment landscape for patients with Group 2 PH-HFpEF. A replay of the webinar can be accessed here.
• Presented Positive TX45 Phase 1a Results at AHA 2024: In November 2024, detailed results from the Phase 1a trial of TX45 was presented in a poster at the American Heart Association (AHA) Scientific Sessions. A copy of the poster presentation can be found here.

Upcoming Milestones

• Phase 1b Part B Results Expected 2H’25: Part B of the TX45 Phase 1b hemodynamic clinical trial evaluating single doses of TX45 in subjects with Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (“PH-HFrEF”) enrolled its first patient in March, with topline trial results expected in the second half of 2025.
• Ongoing TX45 APEX Phase 2 Clinical Trial Results Expected in 2026: The global, 24-week APEX Phase 2 clinical trial is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of TX45 administered subcutaneously in subjects with PH-HFpEF, with topline trial results expected in 2026.
• TX2100 GPCR Antagonist for Hereditary Hemorrhagic Telangiectasia (“HHT”) Phase 1 Initiation Expected Q4’25 or Q1’26: TX2100 is a GPCR targeting biotherapeutic being developed as a potential treatment for HHT, the second-most common genetic bleeding disorder. TX2100 remains on track to initiate a Phase 1 clinical trial in Q4’2025 or Q1’2026 following the conclusion of favorable IND enabling studies. A 4-week non-human primate (NHP) dose-range study with a functionally equivalent precursor to TX2100 showed no treatment-related toxicity at doses up to 100 mg/kg. A formulation supporting TX2100 SC dosing has been identified. Both IND enabling NHP GLP toxicology studies and technical development activities to generate GMP drug supply and drug product for TX2100 is expected to start in Q2’2025.

Overview of Financial and Operating Results

• Cash Position: As of December 31, 2024, cash and cash equivalents were $141.2 million, compared to $159.1 million as of September 30, 2024. Tectonic anticipates that, based on current operating assumptions, its current cash and cash equivalents will provide a cash runway into Q4’28, including through key Phase 1b and Phase 2 readouts for TX45, and the progression of the HHT program into clinical development.
• Research and Development Expenses: Research and development expenses were $9.2 million for the three months ended December 31, 2024, as compared to $7.1 million for the three months ended December 31, 2023. The increase was primarily due to higher contract research organization and contract development manufacturing organization costs related to the progression of the Phase 1b and Phase 2 clinical trials of TX45, and early planning and development manufacturing activity for TX2100, respectively. Tectonic also incurred higher employee-related expenses due to an increase in non-cash stock-based compensation during the period.
• General and Administrative Expenses: General and administrative expenses were $4.8 million for the three months ended December 31, 2024, as compared to $2.3 million for the three months ended December 31, 2023. The increase was primarily a result of higher audit, legal and professional services to support operations as a public company. Tectonic also incurred higher employee-related expenses due to an increase in non-cash stock-based compensation during the period.
• Net Loss: For the three months ended December 31, 2024, the Company had a net loss of $12.4 million compared to a net loss of $7.9 million for the three months ended December 31, 2023.

About Group 2 Pulmonary Hypertension in HFpEF

The World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and CpcPH. CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in PVR. Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment.

About TX45, a long-acting Fc-relaxin fusion protein

TX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby.

About TX2100

TX2100 is a GPCR-targeting biotherapeutic that is being developed to treat HHT, the second most common genetic bleeding disorder. In HHT, loss-of-function mutations in the BMP9/10-Endoglin-ALK1-SMAD4 signaling pathway lead to increased expression of factors that promote abnormal blood vessel formation. The abnormal blood vessel formations found in HHT, also known as telangiectasias and arterio-venous malformations or “AVMs”, are prone to spontaneous recurrent and severe bleeding episodes that can be life-threatening, yet there are no approved therapies to treat these patients. The target GPCR for TX2100 is a receptor for an angiogenic factor known to be upregulated in animal models of HHT. By blocking the signaling of this receptor, Tectonic anticipates it can reduce bleeding resulting from the abnormal blood vessel formation seen in HHT. 

About Tectonic

Tectonic is a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit www.tectonictx.com and follow on LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of Tectonic’s product candidates, including the ongoing Phase 1b and Phase 2 clinical trials for its lead program, TX45, in Group 2 PH-HFpEF; the proposed initiation of a Phase 1 clinical trial for its development candidate for a second program in HHT, including its preclinical studies and anticipated endpoints; and the Company’s expected cash runway. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed with the SEC on November 7, 2024, and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit www.tectonictx.com and follow @TectonicTx on X (formerly Twitter) and LinkedIn.

Tectonic Therapeutic, Inc. Statements of Operations and Comprehensive Loss (in thousands, except share and per share data)
	Three Months Ended December 31,								Year Ended December 31,
		2024				2023				2024				2023
Operating expenses:
Research and development	$	9,155			$	7,081			$	41,364			$	36,966
General and administrative		4,834				2,291				16,651				7,682
Total operating expenses		13,989				9,372				58,015				44,648
Loss from operations		(13,989	)			(9,372	)			(58,015	)			(44,648	)
Other income, net:
Change in fair value of SAFE liabilities		—				1,255				(3,610	)			1,255
Loss on issuance of SAFEs		—				(255	)			—				(255	)
Interest income		1,735				132				4,261				581
Interest expense		(23	)			(34	)			(107	)			(152	)
Other expense		(96	)			405				(511	)			396
Total other income, net		1,616				1,503				33				1,825
Net loss		(12,373	)			(7,869	)			(57,982	)			(42,823	)
Other comprehensive loss:
Foreign currency translation adjustment		83				(11	)			9				(11	)
Comprehensive loss	$	(12,290	)		$	(7,880	)		$	(57,973	)		$	(42,834	)
Net loss per share, basic and diluted	$	(0.84	)		$	(5.01	)		$	(6.83	)		$	(33.76	)
Weighted-average common shares outstanding, basic and diluted		14,792,618				1,570,254				8,490,171				1,268,512

Tectonic Therapeutic, Inc. Select Consolidated Balance Sheet Data (in thousands, unaudited)
	December 31,
		2024			2023
Cash and cash equivalents	$	141,239		$	28,769
Working capital*		135,247			(10,004	)
Total assets		152,905			39,399
Total stockholders’ equity (deficit)		140,776			(84,636	)
*Working capital is defined as current assets less current liabilities.

Contacts:

Investors:
Dan Ferry
LifeSci Advisors
[email protected]
(617) 430-7576

Media:
Kathryn Morris
The Yates Network
[email protected]
(914) 204-6412

Potentially best-in-class RAS-targeting franchise advancing with both ERAS-0015 and ERAS-4001 expected to enter the clinic in 2025

Ongoing Phase 3 SEACRAFT-2 registrational trial progressing well with Stage 1 randomized data expected in H2 2025

Robust balance sheet with cash, cash equivalents, and marketable securities of $440 million as of December 31, 2024 is expected to fund operations into H2 2027

SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) — Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today provided business updates and reported financial results for the fiscal quarter and full year ended December 31, 2024.

“In 2024, we prepared our RAS-targeting franchise to enter the clinic and further advanced our registrational program for naporafenib. The high enthusiasm for our RAS-targeting franchise is encouraging, particularly as our potential best-in-class pan-RAS molecular glue ERAS-0015 and our potential first-in-class pan-KRAS inhibitor ERAS-4001 approach the clinic. The high prevalence of KRAS alterations and the significant unmet need among these patients offer substantial opportunities for both candidates in key indications, namely colorectal, lung, pancreatic, and other solid tumor cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “The SEACRAFT-2 trial is progressing well, and with FDA Fast Track Designation (FTD) granted in NRASm melanoma, this combination has the potential to be first-to-market in this area of high unmet need with no approved targeted therapies.”

Dr. Lim added, “We have an exciting year ahead focused on shutting down RAS and expect multiple value drivers in 2025 and beyond. In the second half of 2025, we expect Stage 1 randomized data from SEACRAFT-2 in patients with NRASm melanoma. For our RAS-targeting franchise, we expect investigational new drug (IND) submissions for ERAS-0015 in mid-second quarter and for ERAS-4001 in the second quarter of 2025. We continue to be well capitalized and capital efficient and have revised our cash runway guidance from the first half of 2027 to the second half of 2027.”

Research and Development (R&D) Highlights

RAS-Targeting Franchise

• Announced Progress Across RAS-Targeting Franchise: In October 2024, Erasca presented a program update for the pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 as part of a virtual investor event. The updates highlighted the rapid progress observed across both programs including in-house confirmation of potential best-in-class profiles for both agents and completion of many key activities to support IND submissions.
• In-Licensed Potential Best-in-Class and First-in-Class RAS-Targeting Franchise: In May 2024, Erasca announced exclusive license agreements for two preclinical RAS programs—a potential best-in-class pan-RAS molecular glue (ERAS-0015) and a potential first-in-class pan-KRAS inhibitor (ERAS-4001). ERAS-0015 and ERAS-4001 are potent, orally bioavailable molecules with complementary RAS inhibitory mechanisms. ERAS-0015 has the potential to address unmet medical needs in approximately 2.7 million patients who are diagnosed annually worldwide with RAS-mutant tumors, including the more than 2.2 million patients with KRAS-mutant tumors whom ERAS-4001 could also address.

Naporafenib Program

• Presented Promising SEACRAFT-1 Phase 1b Data: In October 2024, Erasca announced promising initial Phase 1b data for naporafenib plus trametinib (MEKINIST^®) in the melanoma cohort of SEACRAFT-1 at the 36^th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics. Efficacy and tolerability data supported the rationale for pursuing an NRASm melanoma tissue-specific indication and reinforced the potential of the ongoing Phase 3 SEACRAFT-2 registrational trial, which was initiated in the second quarter of 2024.
• Analysis of Median Overall Survival (mOS) Data for Naporafenib and Trametinib: In March 2024, a pooled analysis of patients with NRASm melanoma dosed with the combination of naporafenib and trametinib at two different doses across two different trials (Phase 1b and Phase 2) showed an mOS of 13.0 and 14.1 months, respectively. The pooled dataset compared favorably relative to historical benchmarks.

Corporate Highlights

• Extended Cash Runway into H2 2027: In 2024, Erasca raised $251 million in equity financings, including a $45 million oversubscribed private placement financing and a $184 million oversubscribed underwritten offering, both of which were led by high-quality new and existing healthcare-focused investors and both of which helped extend our anticipated cash runway into the second half of 2027.

• Strengthened Leadership Team and RDCAB: Erasca strengthened its leadership team and Research, Development, and Commercial Advisory Board (RDCAB) with three key appointments. 
  • Michael Humphries, Ph.D., was appointed as vice president of medical affairs, bringing to Erasca over 15 years of medical affairs, clinical development, and drug discovery experience at Array Biopharma, Bayer Oncology, ARIAD Pharmaceuticals, Takeda, AnHeart Therapeutics, and Nuvation Bio. His leadership includes three U.S. launches of next-generation tyrosine kinase inhibitors in three variants of oncogene-addicted non-small cell lung cancer (NSCLC). In his most recent role at Nuvation Bio, Dr. Humphries served as vice president head of medical affairs where he built out the medical affairs strategy, infrastructure, culture, and personnel. He earned his Ph.D. in cell and developmental biology from the University of Colorado at Denver.
  • Yifah Yaron, M.D., Ph.D., was appointed as vice president of clinical development, bringing over 18 years of experience in clinical drug development focusing on oncology. She most recently led clinical teams at Harpoon Therapeutics (acquired by Merck), and served in clinical development roles at Cytomx Therapeutics, Exelixis, and Genentech. During her time at Exelixis, Dr. Yaron held increasing leadership responsibilities on the cabozantinib program, including serving as a member of the clinical filing team for the first indication in medullary thyroid cancer. Dr. Yaron completed an oncology fellowship at UCSF and an internal medicine residency at University of Rochester Strong Memorial Hospital. She earned her M.D. and Ph.D. degrees (Ph.D. in biological chemistry) as well as her B.S. in biology from the University of California, Los Angeles.
  • Jean-Michel Vernier, Ph.D., was appointed as senior chemistry advisor with 25+ years of drug discovery and development experience. He currently serves as senior vice president of chemistry at Radionetics Oncology and previously served as Erasca’s vice president of chemistry. He held positions of increasing responsibilities at several companies, including Ignyta, Ardea Biosciences, Merck Research Laboratories, and SIBIA Neurosciences. Throughout his career, Dr. Vernier has led departments engaged in early-stage drug discovery programs and drug substance GMP production. He has co-authored more than 30 peer-reviewed publications and is an inventor on more than 50 U.S. patents. Dr. Vernier earned his Ph.D. in synthetic organic chemistry from the University Louis Pasteur, Strasbourg, France, and was a postdoctoral fellow at Colorado State University.

Key Upcoming Milestones

• SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
  • Phase 3 Stage 1 randomized dose optimization data expected in H2 2025
• AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors
  • IND filing expected in mid-Q2 2025
  • Initial Phase 1 monotherapy data in relevant tumor types expected in 2026
• BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors
  • IND filing expected in Q2 2025
  • Initial Phase 1 monotherapy data in relevant tumor types expected in 2026

Fourth Quarter and Full Year 2024 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $440.5 million as of December 31, 2024, compared to $322.0 million as of December 31, 2023.

Research and Development (R&D) Expenses: R&D expenses were $26.1 million for the quarter ended December 31, 2024, compared to $24.8 million for the quarter ended December 31, 2023. The increase was primarily driven by increases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities, and outsourced services and consulting fees. R&D expenses were $115.4 million for the full year ended December 31, 2024, compared to $103.8 million for the full year ended December 31, 2023. Erasca also recorded $22.5 million of in-process R&D expense during the year ended December 31, 2024 for upfront payments under Erasca’s ERAS-0015 and ERAS-4001 license agreements.

General and Administrative (G&A) Expenses: G&A expenses were $9.6 million for the quarter ended December 31, 2024, compared to $9.1 million for the quarter ended December 31, 2023. The increase was primarily driven by an increase in personnel costs, including stock-based compensation expense. G&A expenses were $41.7 million for the full year ended December 31, 2024, compared to $37.7 million for the full year ended December 31, 2023.

Net Loss: Net loss was $32.2 million for the quarter ended December 31, 2024, compared to $29.7 million for the quarter ended December 31, 2023. For the full year ended December 31, 2024, Erasca reported a net loss of $161.7 million, or $(0.69) per basic and diluted share, compared to a net loss of $125.0 million, or $(0.83) per basic and diluted share, for the full year ended December 31, 2023.

About Erasca

At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.

Cautionary Note Regarding Forward-Looking Statements

Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits and potential patient population for each of our product candidates, including naporafenib, ERAS-0015, and ERAS-4001; the planned advancement of our development pipeline, including the anticipated timing of data readouts for the SEACRAFT-2, AURORAS-1, and BOREALIS-1 trials; the anticipated timing of the IND submissions for the AURORAS-1 and BOREALIS-1 trials; and the sufficiency of our cash, cash equivalents, and marketable securities to fund operations into the second half of 2027. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; preliminary results of clinical trials are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and more patient data become available; the analysis of pooled Phase 1 and Phase 2 naporafenib plus trametinib data covers two clinical trials with different designs and inclusion criteria, which cannot be directly compared, and therefore may not be a reliable indicator of survival data; due to differences between trial designs and subject characteristics, comparing clinical data across different trials may not be a reliable indicator of such data; results from preclinical studies or early clinical trials not necessarily being predictive of future results; we only have one product candidate in clinical development and all of our other development efforts are in the preclinical or development stage; our SEACRAFT trials may not support the registration of naporafenib; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, data readout, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; the inability to realize any benefits from our current licenses, acquisitions, and collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; later developments with the FDA or EU health authorities may be inconsistent with the feedback received to date regarding our development plans and trial designs; Fast Track Designation may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2024, 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 we undertake 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.

Erasca, Inc. Selected Consolidated Balance Sheet Data (In thousands) (Unaudited)
		December 31,				December 31,
		2024				2023
Balance Sheet Data:
Cash, cash equivalents, and marketable securities		$	440,473				$	321,992
Working capital			277,398					294,520
Total assets			502,526					395,297
Accumulated deficit			(767,663	)				(606,013	)
Total stockholders’ equity			423,499					316,686

Erasca, Inc. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited)
		Three months ended December 31,								Year ended December 31,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	26,122			$	24,805			$	115,359			$	103,821
In-process research and development			—				—				22,500				—
General and administrative			9,590				9,066				41,728				37,704
Total operating expenses			35,712				33,871				179,587				141,525
Loss from operations			(35,712	)			(33,871	)			(179,587	)			(141,525	)
Other income (expense)
Interest income			5,283				4,237				20,093				16,712
Other expense, net			(1,803	)			(67	)			(2,156	)			(229	)
Total other income (expense), net			3,480				4,170				17,937				16,483
Net loss		$	(32,232	)		$	(29,701	)		$	(161,650	)		$	(125,042	)
Net loss per share, basic and diluted		$	(0.11	)		$	(0.20	)		$	(0.69	)		$	(0.83	)
Weighted-average shares of common stock used in computing net loss per share, basic and diluted			282,845,918				150,732,123				233,817,916				150,184,994
Other comprehensive income (loss):
Unrealized (loss) gain on marketable securities, net			(1,420	)			652				328				1,118
Comprehensive loss		$	(33,652	)		$	(29,049	)		$	(161,322	)		$	(123,924	)

MEKINIST^® is a registered trademark owned by or licensed to Novartis AG, its subsidiaries, or affiliates.

Contact:

Joyce Allaire
LifeSci Advisors, LLC
[email protected]

Source: Erasca, Inc.

GREENWICH, Conn., March 20, 2025 (GLOBE NEWSWIRE) — Oxford Lane Capital Corp. (NasdaqGS: OXLC) (NasdaqGS: OXLCP) (NasdaqGS: OXLCL) (NasdaqGS: OXLCO) (NasdaqGS: OXLCZ) (NasdaqGS: OXLCN) (NasdaqGS: OXLCI) (NasdaqGS: OXLCG) (the “Company”) today announced that its board of directors (the “Board”) has authorized a program to repurchase up to $150.0 million worth of the Company’s common stock in the open market (the “Share Repurchase Program”).

The timing, manner, price and amount of any share repurchases will be determined by the Company, in its discretion, based upon the evaluation of economic and market conditions, the Company’s stock price, applicable legal, contractual and regulatory requirements and other factors. The Share Repurchase Program is expected to be in effect until March 20, 2026, unless extended or until the aggregate repurchase amount has been expended. The Share Repurchase Program does not require the Company to repurchase any specific number of shares, and the Company cannot assure stockholders that any shares will be repurchased under the Share Repurchase Program. The Share Repurchase Program may be suspended, extended, modified or discontinued at any time.

The Company has cash on its balance sheet of over $300 million as of March 20, 2025, representing capital available for opportunistic investments and/or share repurchases in open market transactions through the Share Repurchase Program.

About Oxford Lane Capital Corp.

Oxford Lane Capital Corp. is a publicly-traded registered closed-end management investment company principally investing in debt and equity tranches of collateralized loan obligation (“CLO”) vehicles. CLO investments may also include warehouse facilities, which are financing structures intended to aggregate loans that may be used to form the basis of a CLO vehicle.

Forward-Looking Statements

This press release contains forward-looking statements subject to the inherent uncertainties in predicting future results and conditions. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements. These statements are not guarantees of future performance, conditions or results and involve a number of risks and uncertainties. Certain factors could cause actual results and conditions to differ materially from those projected in these forward-looking statements. These factors are identified from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to update such statements to reflect subsequent events, except as may be required by law.

Contact:

Bruce Rubin
203-983-5280

• Enrollment completed in Phase 2a CBeyond™
   trial of CB1 inhibitor, nimacimab, in obesity and overweight
• Faster-than-expected enrollment enables full top-line Phase 2a data in late Q3/early Q4 2025, ahead of schedule; interim analysis removed
• Phase 2a dosing extended to 52 weeks to enhance long-term safety, tolerability, and efficacy data
• Cash runway projected through at least Q1 2027

SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (NASDAQ: SKYE) (“Skye” or the “Company”), a clinical stage biopharmaceutical company pioneering next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the fourth quarter and full year ended December 31, 2024, along with key accomplishments and upcoming milestones.

“Skye’s prime accomplishment in 2024 was the initiation and rapid advancement of its comprehensive Phase 2a clinical study of nimacimab, a novel and differentiated CB1 inhibitor,” said Punit Dhillon, President & CEO of Skye. “Maturation of the obesity therapeutics landscape, including expanding clinical evidence, M&A, and licensing, highlights the strategic importance of alternative mechanisms of action with attributes differentiated from incretins. We believe nimacimab’s product profile is well-positioned to potentially fulfill critical unmet needs in this rapidly evolving therapeutic area.

“Our team showed discipline in capital allocation and focus in executing the Company’s priorities. We surpassed our enrollment target ahead of schedule and have to-date executed the Phase 2a clinical plan on target and within our budget. We disclosed preclinical data in November 2024 which achieved significant dose-dependent weight loss, significant fat mass loss with lean mass preservation, and dose-dependent improvement in glucose tolerance. These outcomes are indicative of the potentially compelling attributes of Skye’s highly peripherally-restricted CB1 inhibitor. In 2025 and beyond we will continue to apply this discipline and focus. We are enthusiastic about our updated clinical development plan, which will dramatically speed up our path to important 52-week treatment data from this extension study. Robust data in 2025 and 2026 will be valuable to various stakeholders and inform our regulatory engagement for future studies and decision-making.”

Clinical Highlights: CBeyond™
 Phase 2 Obesity Trial

• CBeyond™
   trial completed enrollment of 136 patients: Study enrollment exceeded the initial target of 120, with data blinded through the completion of the 26-week treatment and 13-week follow-up period.
• Data Safety Monitoring Board reviews completed: Two independent data safety monitoring board reviews have been successfully completed.
• 16 US Clinical Sites: Welcomed a leading academic center of excellence in obesity as a clinical trial site during Q1 2025.
• Accelerated timeline for 26-week data
  to late Q3/early Q4 2025: Due to faster-than-anticipated enrollment the interim analysis has been removed and top line data is expected to be reported earlier than previously reported.
• Expansion of the CBeyond™
   trial: To obtain 52 weeks of treatment data, the trial extension increases the originally planned 26 weeks of treatment to provide a longer-term assessment of safety, tolerability and efficacy. The protocol extension will provide for continued assessment of both the nimacimab monotherapy (primary endpoint) and the nimacimab/GLP-1 combination cohort (exploratory endpoint).

Research & Development Highlights

• Vital role and sufficiency of peripherally-targeted CB1 inhibition: Initial data from our diet-induced obesity model in mice released in November 2024 confirms that central CB1 inhibition is not required, and supports our hypothesis that nimacimab’s peripherally-targeted CB1 inhibition drives significant weight loss and improved metabolic parameters, consistent with the compound’s differentiated mechanism of action. An ongoing effort to characterize various attributes of nimacimab’s capabilities as the most peripherally restricted CB1 inhibitor is expected to result in further preclinical data outcomes.
• Broadening metabolic pathway understanding: Current studies are leveraging translational models to demonstrate nimacimab’s role in modulating hormones, inflammatory mediators, lipid metabolism, and glycemic control. We believe that additional data expected in the coming quarters may further clarify nimacimab’s potential across a range of metabolic disorders.
• Next-generation GPCR programs: The Company is advancing development of next-generation GPCR-targeting molecules designed to address diverse metabolic disorders.

Manufacturing Highlights

• Strengthening manufacturing: Advancing activities in collaboration with contract manufacturing organizations to prepare for future clinical demand for nimacimab and further optimize its potential for the treatment of obesity, overweight, and related metabolic disorders.
• Optimizing scale-up processes: Evaluating modifications to upstream and downstream manufacturing processes to improve product yield and establish a commercial manufacturing process that is reliable and repeatable for large-scale commercial production.
• Advancing toward monthly dosing: We are working to optimize nimacimab’s formulation and delivery to transition from weekly to monthly dosing to potentially improve patient experience, adherence, and commercial viability.

Corporate


Highlights

• Chief Development Officer promotion: Skye recently promoted Tu Diep, to COO, recognizing his leadership throughout the Company. In this role, Mr. Diep is overseeing our development operations, CMC, corporate development and broader strategic execution.
• Strengthened the internal and external chemistry, manufacturing, and controls team: During 2024, Skye added to its team with seasoned individuals who bring significant experience in quality control and scale-up to nimacimab’s manufacturing processes.
• Resolved litigation matter: Skye settled its insurance litigation case and received $2 million in cash proceeds from its former D&O carrier in the fourth quarter of 2024.

Upcoming Milestones

• Q2 2025: Nimacimab preclinical data being presented at scientific/medical conferences.
• Q2 2025: Analyst event in conjunction with the Scientific Sessions of the American Diabetes Association (ADA) in June to introduce additional preclinical data, market research insights, and other aspects of the Company’s development program.
• Late Q3/early Q4 2025: Phase 2a CBeyond top-line data; full patient enrollment over 26 weeks of treatment and follow-up.

Fourth Quarter and Full
Year 2024 Financial Results:

Balance Sheet Highlights:

• In January and March 2024, Skye closed two private investment in public equity transactions which collectively resulted in approximately $83.6 million in net proceeds.
• Cash and cash equivalents totaled $68.4 million on December 31, 2024. The Company expects its current capital to fund projected operations and key clinical milestones through at least Q1 2027, including completion of its Phase 2a study for nimacimab and Phase 2b manufacturing but excluding the Phase 2b clinical study or manufacturing activities necessary to supply a Phase 3 clinical study.
• Elimination of all related party balances, including the conversion of $5 million of debt to equity.

Operating Results:

• R&D Expenses:

  Research and development (R&D) expenses for the three months ended December 31, 2024, were $7.8 million, as compared to $1.6 million for the same period in 2023. The increase was primarily due to contracted clinical and manufacturing costs associated with our Phase 2 clinical trial for nimacimab in obesity and employee related benefits.

  R&D expenses for the year ended December 31, 2024, were $18.7 million, as compared to $5.8 million for the same period in 2023. The increase was primarily due to contracted clinical and manufacturing costs associated with our Phase 2 clinical trial for nimacimab in obesity. The remainder of the increase resulted from increases in discovery research efforts, consulting fees, employee benefits driven by increases in headcount, and general expenses.

• G&A Expenses:

  General and administrative (G&A) expenses for the three months ended December 31, 2024, were $4.6 million, as compared to $2.5 million for the same period in 2023. The increase was primarily related to non-cash incentive stock-based compensation, payroll, benefits and other employee costs, professional services including fees for tax, audit, legal services, financial advisory services, and other general business expenses.

  G&A expenses for the year ended December 31, 2024, were $17.7 million, as compared to $7.9 million for the same period in 2023. The increase was primarily related to non-cash incentive stock-based compensation, professional services including fees for tax, audit, legal services, financial advisory services, patent prosecution for nimacimab intellectual property, other general business expenses.

• Net Loss:

  Net loss for the three months ended December 31, 2024, totaled $9.7 million, with non-cash share-based compensation expense of $2.1 million, compared to $4.4 million for the year ended 2023, with non-cash share-based compensation expense of $0.6 million.

  Net loss for the year ended December 31, 2024, totaled $26.6 million, with non-cash share-based compensation expense of $8.3 million, compared to $37.6 million for the year ended 2023, with non-cash share-based compensation expense of $1.0 million. The primary reason for the significant decrease related to the acquisition of the nimacimab in-process research and development asset for $21.2 million during the year ended December 31, 2023, all of which was expensed upon acquisition. In addition, during 2024 we recognized a $4.2 million gain from the partial derecognition of contingent liabilities and a $2.0 million gain from insurance recoveries related to legal proceedings, $3.0 million in interest income and a gain of $1.4 million from the sale of real estate.

Conference Call Details

Skye will host a conference call to discuss its FY 2024 and Q4 2024 results at 1:30 p.m. PT/4:30 p.m. ET today, March 20th. The live streaming of the call can be accessed at the Skye Investor Relations website, along with the Company’s earnings press release, financial tables, and investor presentation. Following the call, a replay and transcript will be available at the same website.

About Skye Bioscience

Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye’s strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye is conducting a Phase 2 clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding: Skye’s future plans and prospects, Skye’s product development plan for nimacimab; the planned timing for reporting of data from Skye’s phase 2a study of nimacimab in obesity; the therapeutic potential of nimacimab, including based on Skye’s diet induced obesity mouse model; the potential applications of nimacimab; expectations around nimacimab’s differentiated mechanism of action; expectations regarding the superior safety and tolerability profile of nimacimab relative to other small molecule CB1 inhibitors and the expected timing through which our current cash and cash equivalents will fund our operating plans. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “expects,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company’s periodic filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Skye’s most recent Annual Report on Form 10-K. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.

SKYE BIOSCIENCE, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS
	Three Months Ended December 31 (Unaudited)								Year Ended December 31
	2024				2023				2024				2023
Operating expenses
Research and development	$	7,793,156			$	1,591,494			$	18,701,694			$	5,819,461
Cost to acquire IPR&D asset		—				—				—				21,215,214
General and administrative		4,622,945				2,494,763				17,725,741				7,852,340
Change in estimate for legal contingency		—				—				(4,234,717	)			(151,842	)
Income from insurance recovery		(1,750,000	)			—				(2,000,000	)			—
Total operating expenses		10,666,101				4,086,257				30,192,718				34,735,173
Operating loss		(10,666,101	)			(4,086,257	)			(30,192,718	)			(34,735,173	)
Other (income) expense
Interest expense		(46,914	)			430,135				749,308				906,270
Interest income		(732,274	)			(50,305	)			(3,028,762	)			(99,974	)
Wind-down costs		—				(46,157	)			—				409,347
(Gain) loss from asset sale		(140,434	)			—				(1,358,412	)			307,086
Debt conversion inducement expense		—				—				—				1,383,285
Other expense (income)		—				—				2,200				(3	)
Total other (income) expense, net		(919,622	)			333,673				(3,635,666	)			2,906,011
Loss before income taxes		(9,746,479	)			(4,419,930	)			(26,557,052	)			(37,641,184	)
Provision for income taxes		—				—				10,071				3,600
Net loss	$	(9,746,479	)		$	(4,419,930	)		$	(26,567,123	)		$	(37,644,784	)
Loss per common share
Basic	$	(0.24	)		$	(0.36	)		$	(0.73	)		$	(5.37	)
Diluted	$	(0.24	)		$	(0.36	)		$	(0.73	)		$	(5.37	)
Weighted average shares of common stock outstanding used to compute loss per share:
Basic		39,968,601				12,343,269				36,486,519				7,006,038
Diluted		39,968,601				12,343,269				36,486,519				7,006,038

SKYE BIOSCIENCE, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS
	December 31, 2024				December 31, 2023
ASSETS
Current assets
Cash and cash equivalents	$	68,415,741			$	1,256,453
Restricted cash		—				9,080,202
Prepaid expenses		201,962				194,259
Other current assets		2,209,544				1,119,929
Total current assets		70,827,247				11,650,843
Property and equipment, net		1,432,752				43,276
Operating lease right-of-use asset		449,864				237,983
Other assets		53,910				8,309
Total assets	$	72,763,773			$	11,940,411
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable	$	569,252			$	956,754
Accrued interest – related party		—				126,027
Accrued interest – legal contingency		—				234,750
Accrued payroll liabilities		1,114,255				888,381
Other current liabilities		654,201				991,805
Estimate for accrued legal contingencies and related expenses		1,818,751				6,259,246
Convertible note – related party, net of discount		—				4,371,998
Operating lease liability, current portion		182,428				72,038
Total current liabilities		4,338,887				13,900,999
Non-current liabilities
Operating lease liability, net of current portion		273,162				171,230
Total liabilities		4,612,049				14,072,229
Commitments and contingencies
Stockholders’ equity (deficit)
Preferred stock, $0.001 par value; 200,000 shares authorized at December 31, 2024 and December 31, 2023; no shares issued and outstanding at December 31, 2024 and December 31, 2023		—				—
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2024 and December 31, 2023; 30,974,559 and 12,349,243 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively		30,975				12,349
Additional paid-in-capital		199,070,421				102,238,382
Accumulated deficit		(130,949,672	)			(104,382,549	)
Total stockholders’ equity (deficit)		68,151,724				(2,131,818	)
Total liabilities and stockholders’ equity (deficit)	$	72,763,773			$	11,940,411

Contacts

Investor Relations
[email protected]
(858) 410-0266

LifeSci Advisors, Mike Moyer
[email protected]
(617) 308-4306

Media Inquiries
LifeSci Communications, Michael Fitzhugh
[email protected]
(628) 234-3889

WAUWATOSA, Wis., March 20, 2025 (GLOBE NEWSWIRE) — On March 20, 2025, the Board of Directors of Waterstone Financial, Inc. (NASDAQ: WSBF) declared a regular quarterly cash dividend of $0.15 per common share.  The dividend is payable on May 1, 2025, to shareholders of record at the close of business on April 8, 2025.

About Waterstone Financial, Inc:

Waterstone Financial, Inc. is the savings and loan holding company for WaterStone Bank, a community-focused financial institution established in 1921. WaterStone Bank offers a comprehensive suite of personal and business banking products and operates 14 branch locations across southeastern Wisconsin. WaterStone Bank is also the parent company of WaterStone Mortgage Corporation, a national lender licensed in 48 states.

With a long-standing commitment to innovation, integrity, and community service, Waterstone Financial, Inc. supports the financial and homeownership goals of customers nationwide.

For more information about WaterStone Bank, go to wsbonline.com.

Contact: Mark R. Gerke
Chief Financial Officer
414-459-4012
[email protected]