Prime Medicine Reports First Quarter 2024 Financial Results and Provides Business Updates By Investing.com

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— Announced FDA clearance of first-ever IND application for a Prime Editing product, PM359, for the treatment of CGD; initial data from planned Phase 1/2 clinical trial expected in 2025 —

— Presented new preclinical data demonstrating broad potential of Prime Editing technology at LNP Formulation and Process Development Summit and ASGCT 2024 —

— Appointed Tony Coles, M.D. as senior advisor —

CAMBRIDGE, Mass., May 10, 2024 (GLOBE NEWSWIRE) — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

In 2024, we expect to bring the first-ever Prime Editing-based product candidate to patients, while continuing to strengthen our modular Prime Editing platform and advance our next wave of programs across a range of target tissues, said Keith Gottesdiener, M.D., President and Chief Executive Officer of Prime Medicine. In recent months, we made meaningful progress toward this goal. In April, the U.S. Food and Drug Administration (FDA) cleared our investigational new drug (IND) application for PM359, our Prime Editor for the treatment of chronic granulomatous disease (CGD), and the first-ever Prime Editor product candidate to advance to the clinic. This represents a watershed moment for gene editing and for Prime Medicine, and we are eager to initiate our Phase 1/2 trial as we work to establish the potential for PM359 to correct the disease-causing mutation of CGD and ameliorate this devastating disease.

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Dr. Gottesdiener continued, At recent scientific meetings, we also presented new preclinical data showcasing the safety and broad potential of our Prime Editing technology across our pipeline programs and highlighting our proprietary delivery capabilities. Together, these presentations reinforce efforts across our core areas of focus “ hematology and immunology, liver, lung, ocular and neuromuscular disease “ and support our plans to advance a diverse pipeline into the clinic. Finally, in March, we were fortunate to welcome Dr. Tony Coles as a senior advisor to Prime Medicine. Tony brings a wealth of strategic perspectives and company growth experience in innovative drug discovery and development, and we look forward to his many contributions as Prime Medicine enters its next phase of growth.

Recent Business Updates

Chronic Granulomatous Disease (CGD)

  • In April 2024, Prime Medicine announced that the FDA had cleared the Company’s IND application for PM359 for the treatment of CGD, enabling the Company to initiate its planned global Phase 1/2 clinical trial in the United States. The Phase 1/2 clinical trial is a multinational, first-in-human trial designed to assess the safety, biological activity and preliminary efficacy of PM359 in adult and pediatric study participants. Prime Medicine expects to report initial clinical data from the Phase 1/2 trial in 2025.
  • At the American Society of Cell & Gene Therapy (ASCGT) 7th Annual Meeting (May 7 “ 11, 2024), Prime Medicine presented new preclinical data from its CGD program, demonstrating the ability of Prime Editing to correct the disease-causing mutation in CGD patient blood stem cells, leading to restoration of neutrophil function in an in vivo mouse model with no off-target edits detected. Read a summary of the data presented here.

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Broader Pipeline and Prime Editing Platform

  • Also at the ASGCT Meeting and at the 3rd Annual LNP Formulation and Process Development Summit (April 29 “ May 2, 2024), Prime Medicine presented new preclinical data from across Prime Medicine’s platform and initial pipeline showcasing the broad potential of its Prime Editing technology and supporting the advancement of its pipeline programs. Highlights included:
    • Details on Prime Medicine’s proprietary end-to-end capabilities in lipid nanoparticle discovery, as well as its development of non-viral delivery technologies for planned use in liver programs and, potentially, in programs across hematology/immunology and lung.
    • Additional preclinical data from Prime Medicine’s Rhodopsin (RHO)-mediated Retinitis Pigmentosa (RHO-RP) program, supporting Prime Medicine’s ability to correct multiple mutations in the RHO gene and showing that the correction of pathogenic mutations in humanized mouse models resulted in preservation of photoreceptors.
    • A presentation on the development and characterization of Prime Medicine’s off-target assays, which collectively have supported the observed specificity and minimal, if any, off-target activity of Prime Editing.

Corporate

  • In March 2024, Prime Medicine appointed Tony Coles, M.D. as its senior advisor. Dr. Coles is a seasoned biopharmaceutical leader, with experience translating groundbreaking science into novel medicines. Dr. Coles currently serves as Chairperson of the board of directors at Cerevel Therapeutics Holdings, Inc.; he formerly also held the role of Cerevel’s Chief Executive Officer (CEO). He previously co-founded and served as Chairperson and CEO of Yumanity Therapeutics, Inc. Earlier, Dr. Coles was the President, CEO and Chairperson of Onyx Pharmaceuticals, Inc. and, President, CEO and member of the board of directors of NPS Pharmaceuticals, Inc. He currently serves on the board of directors of Regeneron (NASDAQ:) Pharmaceuticals, Inc. Dr. Coles previously served as a director of CRISPR Therapeutics AG, Laboratory Corporation of America (NYSE:) Holdings, Campus Crest Communities, Inc., and McKesson Corporation (NYSE:).

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I have devoted my career to advancing new therapies to treat some of the most challenging, intractable diseases and I am now excited to work with Prime Medicine in its mission to develop next-generation gene-editing therapeutics, said Dr. Coles. Now is a particularly exciting moment, as Prime Medicine is initiating the first clinical trial of a Prime Editor and continuing to generate encouraging preclinical data across its pipeline. I look forward to working with the company in support of the ultimate goal of developing one-time, curative genetic therapies for diseases that collectively impact millions of people.

Anticipated Upcoming Milestones

Prime Medicine expects the following activities and next steps to drive Prime Medicine forward and support the Company’s maturation into a clinical-stage company:

Hematology and Immunology:

  • Announce initial clinical data from the Phase 1/2 clinical trial of PM359 in CGD in 2025.
  • Advance Shielded Hematopoietic Stem Cell (HSC) and Immunotherapy Pairs (SCIP) technology, establish proof-of-concept in HSC and immunotherapy and identify first clinical program(s) with this approach in 2024.
  • Advance differentiated CAR-T program, using PASSIGE technology, into lead optimization.

Liver:

  • Continue to advance preclinical studies for three liver programs and initiate IND-enabling activities for at least one in 2024, leading to an IND and/or clinical trial application (CTA) in the second half of 2025 or first half of 2026.

Ocular:

  • Nominate development candidate for RHO-RP program and initiate IND-enabling activities in 2024.

Neuromuscular:

  • Continue to advance Friedreich’s Ataxia and advance one other program into lead optimization in 2024.
  • In large animal studies, establish adeno-associated virus (AAV) delivery platform and route of administration for neuromuscular programs in 2024.

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First Quarter 2024 Financial Results

  • Research and Development (R&D) Expenses: R&D expenses were $37.8 million for the three months ended March 31, 2024, as compared to $30.9 million for the three months ended March 31, 2023. The increase in R&D expenses was driven by expenses related to the advancement of the Company’s pipeline and platform.
  • General and Administrative (G&A) Expenses: G&A expenses were $11.2 million for the three months ended March 31, 2024, as compared to $9.2 million for the three months ended March 31, 2023.
  • Net Loss: Net loss was $45.8 million for the three months ended March 31, 2024, as compared to $39.4 million for the three months ended March 31, 2023.
  • Cash Position: As of March 31, 2024, cash, cash equivalents, investments and restricted cash were $224.2 million, as compared to $135.2 million as of December 31, 2023.

About Prime Medicine
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around core areas of focus: hematology and immunology, liver, lung, ocular and neuromuscular. Across each core area, Prime Medicine’s initial focus is on genetic diseases with a fast, direct path to treating patients, and those with high unmet need not currently addressable using other gene editing approaches. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential to expand beyond the genetic diseases in its initial pipeline, potentially including immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.

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Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Prime Medicine’s beliefs and expectations regarding: the potential of PM359 to correct the causative mutation of CGD; the anticipated maturation into a clinical-stage company by bringing PM359 into clinical development in 2024 with initial clinical data expected in 2025; the initiation, timing, progress, and results of its research and development programs, preclinical studies and future clinical trials, and the release of data related thereto; the potential for Prime Editors to repair genetic mutations and offer curative genetic therapies for a wide spectrum of diseases; the potential of Prime Editors to reproducibly correct disease-causing genetic mutations across different tissues, organs and cell types, and the capacity of its PASSIGE technology to edit CAR-T cells for the treatment of certain cancers and immune diseases; its continued development and optimization of various non-viral and viral delivery systems; its ability to demonstrate superior off-target profiles for Prime Editing programs; certain activities and next steps to support the Company’s maturation into a clinical-stage company, including opening IND and/or CTA applications, clinical data expectations, establishing proof of concept, advancing programs into lead optimization, advancing preclinical studies and initiating IND-enabling activities, nominating development candidates, and establishing delivery platform and rout of administration; the expansion of Prime Editing’s therapeutic potential and the creation of value through strategic business development to extend the reach and impact of Prime Editing to areas beyond Prime Medicine’s current core areas of focus; exploring business development opportunities that could accelerate existing work and the benefits thereof; the modularity of the Prime Editing platform and the benefits thereof; its expectations regarding the breadth of Prime Editing technology and the implementation of its strategic plans for its business, programs, and technology; and the potential of Prime Editing to unlock opportunities across thousands of potential indications. The words may, might, will, could, would, should, expect, plan, anticipate, intend, believe, expect, estimate, seek, predict, future, project, potential, continue, target and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

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Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties related to Prime Medicine’s product candidates entering clinical trials; the authorization, initiation, and conduct of preclinical and IND-enabling studies and other development requirements for potential product candidates, including uncertainties related to opening INDs and obtaining regulatory approvals; risks related to the development and optimization of new technologies, the results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies; the scope of protection Prime Medicine is able to establish and maintain for intellectual property rights covering its Prime Editing technology; Prime Medicine’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions, including rising interest rates, inflation, and adverse developments affecting the financial services industry. These and other risks and uncertainties are described in greater detail in the section entitled Risk Factors in Prime Medicine’s most recent Annual Report on Form 10-K, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Prime Medicine’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Prime Medicine explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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© 2024 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.

Investor Contact
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com

Media Contact
Dan Budwick, 1AB
dan@1ABmedia.com

 
Condensed Consolidated Balance Sheet Data
(unaudited)
                 
(in thousands)     March 31,
2024
      December 31,
2023
 
Cash, cash equivalents, and investments   $ 210,723      $ 121,665  
Total assets   $ 311,383      $ 193,851  
Total liabilities   $ 67,617      $ 60,780  
Total stockholders’ equity   $ 243,766      $ 133,071  
                 
Condensed Consolidated Statement of Operations
(unaudited)
         
    Three Months Ended
March 31,
(in thousands, except share and per share amounts)     2024       2023  
Collaboration revenue   $ 591     $  
Operating expenses:        
Research and development     37,774       30,880  
General and administrative     11,158       9,153  
Total operating expenses     48,932       40,033  
Loss from operations     (48,341 )     (40,033 )
Other income:        
Change in fair value of short-term investment ” related party     1,166       (1,701 )
Other income, net     1,548       2,135  
Total other income, net     2,714       434  
Net loss before income taxes     (45,627 )     (39,599 )
(Provision for) benefit from income taxes     (134 )     202  
Net loss attributable to common stockholders   $ (45,761 )   $ (39,397 )
Net loss per share attributable to common stockholders, basic and diluted   $ (0.44 )   $ (0.44 )
Weighted-average common shares outstanding, basic and diluted     104,466,178       89,064,895  

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Arhaus price shares target raised by Telsey on stable business outlook By Investing.com

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Friday, Telsey Advisory Group raised its price target for Arhaus Inc (NASDAQ:) shares to $18 from $17, maintaining an Outperform rating. This adjustment reflects confidence in the company’s ability to meet its 2024 guidance, driven by stable business operations and growth initiatives.

Arhaus has been focusing on both customer-facing and operational aspects to foster growth and enhance infrastructure. The company’s product offerings, marketing strategies, and the launch of new showrooms have contributed to a positive demand trend, with a 1.3% increase in the first quarter of 2024.

This performance stands out compared to some of Arhaus’ competitors, such as Ethan Allen (NYSE:) and Havertys, which saw retail demand fall in the same period.

Despite a sluggish start in January, demand trends normalized, with February and March witnessing mid-single to high-single digit increases, followed by another mid-single digit rise in April. Arhaus’ successful warehouse system implementation at its Ohio distribution center has also been completed, further instilling confidence in the company’s trajectory.

Arhaus is well-positioned to continue gaining market share in the premium home furnishings sector, which is estimated to be worth $100 billion by year-end.

The company’s market share is projected to be around 1.5%. Factors such as growing brand recognition, ongoing product launches, and an expanding showroom footprint are expected to drive this growth.

Looking ahead to 2025, Telsey anticipates an improvement in Arhaus’ EBITDA margin as the company moves past the impacts of SKU rationalization and system implementations, and as new stores mature.

The revised price target of $18 is based on applying an enterprise value to EBITDA multiple of around 10 times to the firm’s 2025 EBITDA estimate of $225 million, up from the previous estimate of $222 million.

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InvestingPro Insights

Following Telsey Advisory Group’s updated outlook on Arhaus Inc (NASDAQ:ARHS), real-time data from InvestingPro provides additional context to the company’s financial health and market performance. With a market capitalization of $2.18 billion and a trailing P/E ratio of 17.37, Arhaus is navigating the premium home furnishings sector with a notable Price / Book ratio of 6.39, which may indicate investor confidence in the company’s asset value relative to its share price.

The company’s revenue growth over the last twelve months was modest at 4.78%, and despite a quarterly dip of -3.46%, Arhaus has managed a gross profit margin of 48.27%, reflecting efficient operations. Investors have witnessed a significant return, with a 17.78% increase over the last week and a remarkable 83.95% over the past year, underscoring the company’s strong market performance.

InvestingPro Tips highlight that Arhaus’ liquid assets exceed short-term obligations and the company operates with a moderate level of debt, suggesting financial stability. Additionally, analysts predict profitability for this year, which aligns with the positive sentiment expressed by Telsey Advisory Group. For those seeking a deeper dive into Arhaus’ financials and future prospects, InvestingPro offers 10 additional tips. To access these insights and enhance your investment strategy, consider using the coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.



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BofA raises Elanco share price target on solid core business By Investing.com

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On Thursday, BofA Securities adjusted its outlook on Elanco Animal Health (NYSE:) shares, increasing the price target to $20.00 from the previous $18.00, while reiterating a Buy rating on the stock. The upgrade reflects a positive view of the company’s recent performance and future prospects.

Elanco’s core business exceeded expectations, contributing to an upbeat quarterly update. This performance, along with robust second-quarter guidance, has led to a raised forecast by the analyst. The company’s 2024 product approval timelines have also been pushed out, but not as significantly as some had anticipated.

The revised price objective of $20.00 is now based on a 15 times multiple of BofA Securities’ forecasted FY24 enterprise value to EBITDA (EV/EBITDA), an increase from the previous 14 times multiple. This change is due to a heightened confidence in the company’s product approvals.

The firm’s reiteration of the Buy rating is based on Elanco’s improving core business, the anticipation of a new product cycle, and the expansion of the broader industry. These factors collectively suggest a favorable outlook for the company’s stock.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.



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Hyatt: Q1 Business Travel ‘Extraordinarily Encouraging’

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Hyatt Hotels Corp.’s business travel demand in 2024 has been “extraordinarily encouraging,” with systemwide first-quarter revenue from the sector up 6 percent year over year, with some segments up even higher, president and CEO Mark Hoplamazian said Thursday during an earnings call.

Global business transient revenue “increased approximately 6 percent in the quarter with strength in both January and February, and we saw similar trends in the U.S., a clear sign that business travel continues to recover,” he said.

April systemwide business transient revenue was up 21 percent year over year, Hoplamazian said, although that figure was inflated by the shift of the Easter holiday from April last year to March this year.

Still, Hoplamazian shared other statistics to illustrate the strength of the business travel segment. “Business transient, frankly, in the first quarter, into the second quarter is extraordinarily encouraging,” he said. “Our business transient hotels were up 15 percent, almost 16 percent in the first quarter. Convention hotels were up about 11 percent, just as a hotel type. New York City was up 19 percent. San Jose and Seattle are really going strong. Why? Because technology transient, business transient, was up 30 percent in the first quarter.”

It wasn’t clear if Hoplamazian’s figures were year-over-year revenue, and Hyatt didn’t immediately return a request for clarification, but on the call he said, “these numbers are staggering.”

First-quarter group revenue increased 6 percent year over year, Hoplamazian said, with the May-through-December booking pace up 7 percent from 2023. He called the segment “the gift that keeps on giving.”

Q1 Metrics

Hyatt’s systemwide first-quarter revenue per available room increased 5.5 percent year over year to $131.86, while average daily rate increased 2 percent to $202.33 and occupancy increased 2.2 percentage points to 65.2 percent.

In the United States, RevPAR increased 0.2 percent year over year to $132.68, while ADR dropped 0.4 percent to $205.41 and occupancy increased 0.4 percentage points to 64.4 percent. Hyatt CFO Joan Bottarini said U.S. RevPAR increased about 2 percent when the effect of the Easter shift was excluded.

Hyatt maintained its outlook for a 3 percent to 5 percent year-over-year increase in full-year 2024 RevPAR.

The company’s first-quarter revenue increased to $1.71 billion from $1.68 billion one year prior. Net income increased to $522 million from $58 million in Q1 2023, a figure boosted by sales this year of Hyatt properties in Green Bay, Wis., Aruba and Zurich.

Net rooms increased 5.5 percent year over year to more than 323,400, while Hyatt’s pipeline increased 10 percent to more than 129,000 rooms.

RELATED: Hyatt Q4 performance



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Fox Business launching podcast – Talking Biz News

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The “Fox Business Rundown Podcast” is launching on May 20.

Available on Monday and Fridays, listeners will hear what is trending in business news from Fox Business Network anchors and correspondents. including Taylor Riggs, Kelly O’Grady and Lydia Hu.

The podcast will feature business headlines, along with trending topics such as inflation, artificial intelligence, and economic policy, among others serving as a resource to kick off the work week on Monday and close out the stock market on Fridays. It will also feature insights from CEOs, lawmakers, economists and other top Fox Business reporters to break down the stories impacting Wall Street and Main Street.

The launch of the podcast follows the success of “The Fox News Rundown Podcast”, which saw over 35 million downloads in 2023, with over 5 million unique listeners according to Megaphone.

Listeners can go to FoxBusinessPodcasts.com, Apple Podcasts, Spotify or wherever podcasts are found.



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Kezar Life Sciences Reports First Quarter 2024 Financial Results and Provides Business Update By Investing.com

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  • PALIZADE Phase 2b clinical trial of zetomipzomib in patients with active lupus nephritis actively enrolling; reiterating guidance of topline data in mid-2026
  • PORTOLA Phase 2a clinical trial of zetomipzomib in patients with autoimmune hepatitis actively enrolling; reiterating guidance of topline data in mid-2025
  • KZR-261 dose expansion currently enrolling patients with melanoma; initial study data by year-end
  • Cash, cash equivalents and marketable securities totaled $179.8 million as of March 31, 2024

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases and cancer, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.

We continued to make meaningful progress this past quarter on our mission to develop first-in-class small molecule therapeutics in immunology and oncology. We are focused this year on clinical execution in our PALIZADE and PORTOLA trials and are excited by the strong enrollment activity we have seen to date. said Chris Kirk, Kezar’s Co-Founder and Chief Executive Officer. We are also looking forward to sharing initial results from the dose escalation and dose expansion portions of the KZR-261 study in the fourth quarter of this year.

Zetomipzomib: Selective Immunoproteasome Inhibitor

PALIZADE “ Phase 2b clinical trial of zetomipzomib in patients with active lupus nephritis (LN) (ClinicalTrials.gov: NCT05781750)

  • PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active LN. Target enrollment will be 279 patients, randomly assigned (1:1:1) to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy. Background therapy can, but will not be mandated to, include standard induction therapy. Over the initial 16 weeks, there will be a mandatory corticosteroid taper to 5 mg per day or less. End-of-treatment assessments will occur at Week 53. The primary efficacy endpoint is the proportion of patients who achieve a complete renal response (CRR) at Week 37, including a urine protein-to-creatine ratio (UPCR) of 0.5 or less without receiving rescue or prohibited medications.

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PORTOLA “ Phase 2a clinical trial of zetomipzomib in patients with autoimmune hepatitis (AIH) who have not benefited from standard-of-care treatment (ClinicalTrials.gov: NCT05569759)

  • PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed. Target enrollment will be 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background corticosteroid therapy for 24 weeks, with a protocol-mandated steroid taper by Week 14. The primary efficacy endpoint will measure the proportion of patients who achieve a complete response measured as normalization of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels with a successful corticosteroid taper by Week 24.

KZR-261: Broad-Spectrum Sec61 Translocon Inhibitor

KZR-261-101 “ Phase 1 clinical trial of KZR-261 in patients with locally advanced or metastatic solid malignancies (ClinicalTrials.gov: NCT05047536)

  • The Phase 1 clinical trial of KZR-261 is being conducted in two parts: dose escalation and dose expansion in tumor-specific solid tumors. The study is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, identify a recommended Phase 2 dose and to explore the preliminary anti-tumor activity of KZR-261 in patients with locally advanced or metastatic disease.
  • The dose escalation part of the trial is completing Cohort 9 and reached a maximum tolerated dose of 80mg/m2 based on the presence of reversible neutropenia. A total of 43 patients have been enrolled in the dose escalation part of the trial to date and additional backfill patients may be added to better understand the safety, pharmacokinetics, and pharmacodynamics of KZR-261 at specific dose levels.
  • We are currently enrolling the dose expansion part of the study with a cohort of melanoma patients at a dose level of 60 mg/m2. To date, KZR-261 has shown dose-proportional exposure and no signs of accumulation or altered pharmacokinetics with repeated dosing.

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Financial Results

  • Cash, cash equivalents and marketable securities totaled $179.8 million as of March 31, 2024, compared to $201.4 million as of December 31, 2023. The decrease was primarily attributable to cash used in operations to advance clinical-stage programs.
  • Research and development (R&D) expenses for the first quarter of 2024 decreased by $1.1 million to $17.2 million, compared to $18.3 million in the first quarter of 2023. This decrease was primarily due to the Company’s strategic restructuring in October 2023 to prioritize its clinical-stage programs, reducing personnel-related costs and spending in its early-stage research activities. The decrease was partially offset by the increased clinical trial costs related to the PALIZADE and PORTOLA trials, as well as manufacturing expenses.
  • General and administrative (G&A) expenses for the first quarter of 2024 increased by $0.3 million to $6.5 million compared to $6.2 million in the first quarter of 2023. The increase was primarily due to an increase in non-cash stock-based compensation and personnel-related expenses, offset by a decrease in legal and professional service expenses.
  • Net loss for the first quarter of 2024 was $21.7 million, or $0.30 per basic and diluted common share, compared to a net loss of $22.2 million, or $0.31 per basic and diluted common share, for the first quarter of 2023.
  • Total shares of common stock outstanding were 72.8 million shares as of March 31, 2024. Additionally, there were options to purchase 15.6 million shares of common stock at a weighted-average exercise price of $2.27 per share and 0.2 million restricted stock units outstanding as of March 31, 2024.

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About Kezar Life Sciences (NASDAQ:)

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases and cancer. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2b clinical trial for lupus nephritis and a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. Kezar’s oncology product candidate, KZR-261, targeting the Sec61 translocon and protein secretion pathway, is being evaluated in an open-label Phase 1 clinical trial to assess safety, tolerability and preliminary tumor activity in solid tumors. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook (NASDAQ:), Twitter and Instagram.

Cautionary Note on 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 may, will, can, should, expect, believe, potential, anticipate 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 Kezar’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 Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, initiation, progress, timing, scope and results of clinical trials, the enrollment and expected timing of reporting topline data from our clinical trials, the development of zetomipzomib in additional indications, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes and the likelihood of obtaining regulatory approval of Kezar’s product candidates. Many factors may cause differences between current expectations and actual results, including clinical trial site activation or enrollment rates that are lower than expected, unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, 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 actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the Risk Factors contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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KEZAR LIFE SCIENCES, INC.

Selected Balance Sheets Data

(In thousands)

March 31, 2024

December 31, 2023

(unaudited)

Cash, cash equivalents and marketable securities

$

179,798

$

201,372

Total assets

199,130

221,235

Total current liabilities

16,161

17,744

Total noncurrent liabilities

13,848

15,921

Total stockholders’ equity

169,121

187,570

Summary of Operations Data

(In thousands except share and per share data)

Three Months Ended

March 31

2024

2023

(unaudited)

Operating expenses:

Research and development

$

17,172

$

18,318

General and administrative

6,539

6,206

Total operating expenses

23,711

24,524

Loss from operations

(23,711

)

(24,524

)

Interest income

2,453

2,695

Interest expense

(400

)

(370

)

Net loss

$

(21,658

)

$

(22,199

)

Net loss per common share, basic and diluted

$

(0.30

)

$

(0.31

)

Weighted-average shares used to compute net loss per common share, basic and diluted

72,799,910

72,328,231

Investor and Media Contact:
Gitanjali Jain
Vice President, Investor Relations and External Affairs
Kezar Life Sciences, Inc.
gjain@kezarbio.com

Source: Kezar Life Sciences, Inc.



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Amprius Technologies Reports First Quarter 2024 Business and Financial Results By Investing.com

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FREMONT, Calif.–(BUSINESS WIRE)–Amprius Technologies, Inc. (“Amprius”), (NYSE: AMPX), a leader in next-generation lithium-ion batteries with its Silicon Anode Platform, today announced its business and financial results for the first quarter ended March 31, 2024.

Amprius posted a letter to shareholders on its Investor Relations website, ir.amprius.com, that details the company’s results and provides an update on its business initiatives including product roadmap milestones, manufacturing scale-up progress, and customer acquisition efforts.

Management will also hold a live conference call and webcast today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss its financial results and business updates.

Time: 5:00 pm ET (2:00 pm PT)
Toll-Free Number: 866-424-3442
International Number: 201-689-8548
Webcast: Register and Join

The conference call will be broadcast simultaneously and available for webcast replay here.

About Amprius Technologies, Inc.

Amprius Technologies, Inc. is a leading manufacturer of high-energy and high-power lithium-ion batteries producing the industry’s highest known energy density cells. The company’s commercially available SiMaxx™ batteries deliver up to 450 Wh/kg and 1,150 Wh/L, with third party validation of 500Wh/kg and 1,300 Wh/L. The company’s corporate headquarters is in Fremont, California where it maintains an R&D lab and a MWh scale manufacturing facility for the fabrication of silicon anodes and cells. To serve customer demand, Amprius entered into a lease agreement for an approximately 774,000 square foot facility in Brighton, Colorado and expanded its product portfolio to include the SiCore™ platform. For additional information, please visit amprius.com. Also, see the company’s LinkedIn and Twitter pages.

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Investors
Tom Colton, Chris Adusei-Poku
Gateway Group, Inc.
949-574-3860
IR@amprius.com

Media
Zach Kadletz, Brenlyn Motlagh
Gateway Group, Inc.
949-574-3860
Amprius@gateway-grp.com

Source: Amprius Technologies, Inc.



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Crinetics Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update By Investing.com

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       Late-Breaking Presentations of Initial Results From Phase 2 Studies of Atumelnant (CRN04894) in Congenital Adrenal Hyperplasia and ACTH-Dependent Cushing’s Syndrome Will be Presented at ENDO June 1-4, 2024

           Following Second Positive Phase 3 Study (PATHFNDR-2), Paltusotine NDA Submission in Acromegaly Expected in 2H 2024

           Following Positive Phase 2 Data, Plan to Initiate Paltusotine Phase 3 Study in Carcinoid Syndrome by End of 2024

           Management Hosting Conference Call at 4:30 p.m. ET Today

SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: NASDAQ:), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today reported financial results for the first quarter ended March 31, 2024.

Building on the positive momentum from the first PATHFNDR readout in 2023, Crinetics began 2024 with continued strong performance. Our lead investigational compound, paltusotine, delivered positive data from two consecutive late-stage clinical trials in acromegaly and carcinoid syndrome. With our pivotal PATHFNDR Phase 3 program in acromegaly now complete, we are working diligently to submit an NDA in the second half of 2024. We also intend to discuss the positive results from our Phase 2 study in carcinoid syndrome with the FDA in preparation for the Phase 3 program, which is expected to be initiated by the end of this year, said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.

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The clinical trials for the second compound in our pipeline, atumelnant, which is being developed for the treatment of CAH and Cushing’s disease, continue to enroll patients. We plan to report initial results from a subset of patients from these trials in the second quarter, continued Dr. Struthers. In the first quarter, we strengthened our balance sheet to support commercial readiness for a potential paltusotine launch in acromegaly, as well as to fund the development of our deep clinical and preclinical pipeline. The progress made across our pipeline positions the Company for long-term success and towards achieving our objective to become a fully integrated pharmaceutical company.

First Quarter 2024 and Recent Highlights:

  • Phase 3 PATHFNDR-2 study achieved primary and all secondary endpoints. In March, Crinetics reported positive topline results from its placebo-controlled Phase 3 study of paltusotine in non-pharmacologically treated participants with acromegaly. PATHFNDR-2 was designed to support a treatment indication in those with uncontrolled acromegaly.
  • Phase 2 study of paltusotine in carcinoid syndrome reported positive results. In March, Crinetics reported positive topline results from its open-label Phase 2 study of paltusotine in participants with carcinoid syndrome. Paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.
  • Strengthened balance sheet with $350 million private placement financing. In February, Crinetics announced a private placement equity financing for gross proceeds of approximately $350 million.

Key Upcoming Milestones:

  • Initial results from the ongoing Phase 2 studies of atumelnant in congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome will be presented at the Endocrine Society’s annual meeting, ENDO 2024, being held June 1-4, 2024 in Boston. The Phase 2 studies are evaluating the safety, efficacy and pharmacokinetics of different doses of atumelnant in participants with CAH and Cushing’s disease.
  • Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval of paltusotine for the treatment of acromegaly is anticipated in the second half of 2024.
  • Initiation of a Phase 3 program of paltusotine for carcinoid syndrome by the end of 2024, pending discussions with the FDA.

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First Quarter 2024 Financial Results:

  • Research and development expenses were $53.3 million for the three months ended March 31, 2024, compared to $38.5 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $9.4 million, increased outside services and facilities costs of $3.8 million, and increased spending on manufacturing and development activities of $1.4 million.
  • General and administrative expenses were $20.8 million for the three months March 31, 2024, compared to $12.2 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $5.6 million.
  • Net loss for the three months ended March 31, 2024, was $66.9 million, compared to a net loss of $46.0 million for the same period in 2023.
  • Revenues were $0.6 million for the three months ended March 31, 2024, compared to $2.7 million for the same period in 2023. Revenues were derived from licensing arrangements for our paltusotine product candidate in 2024 and for paltusotine and CRN01941 product candidates in 2023.
  • Unrestricted cash, cash equivalents, and investments totaled $901.0 million as of March 31, 2024, compared to $558.6 million as of December 31, 2023. On February 28, 2024, the company announced a private placement equity financing for gross proceeds of approximately $350 million. Based on its current projections, the company now expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.

Proposed international nonproprietary name under review.

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 9, 2024 at 4:30 p.m. ET. To participate, please dial 1-888-886-7786 (domestic) or 1-416-764-8658 (international) and refer to Conference ID 71864759. To access the webcast, click here. For instant telephone access, click the Call me™ link here. Following the live event, a replay will be available on the Investors section of the Company’s website.

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ABOUT CRINETICS PHARMACEUTICALS
Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Paltusotine, an investigational, first-in-class, oral somatostatin receptor type 2 (SST2) agonist, is in Phase 3 clinical development for acromegaly and in Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics is also developing atumelnant (CRN04894), an investigational, first-in-class, oral ACTH antagonist, that is currently completing Phase 2 clinical studies for the treatment of congenital adrenal hyperplasia (CAH) and Cushing’s disease. All of the Company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves’ disease, thyroid eye disease, diabetes and obesity.

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. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine, including the therapeutic potential and clinical benefits or safety profile thereof; the expected timing of an NDA submission for paltusotine for the treatment or maintenance of treatment of acromegaly in the United States; the expected timing of initiation of a Phase 3 program of paltusotine for carcinoid syndrome; the expected timing of data from studies of atumelnant in congenital adrenal hyperplasia and Cushing’s diseases; and the expected timing through which our cash, cash equivalents, and short-term investments will fund our operating plans. In some cases, you can identify forward-looking statements by terms such as may, will, should, expect, plan, anticipate, could, intend, target, project, contemplates, believes, estimates, predicts, potential, upcoming or continue or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, topline data that we report may change following a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with our interpretation of such results; we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical studies and nonclinical studies; regulatory developments in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company’s periodic filings with the SEC. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading Risk Factors in Crinetics’ periodic reports, including its annual report on Form 10-K for the year ended December 31, 2023 and its Quarterly report on Form 10-Q for the quarter ended March 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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CRINETICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(In thousands, except per share data)
(Unaudited)
 
  Three months ended March  31,  
STATEMENTS OF OPERATIONS DATA: 2024     2023  
           
Revenues $ 640     $ 2,679  
Operating expenses:          
Research and development   53,341       38,468  
General and administrative   20,828       12,189  
Total operating expenses   74,169       50,657  
Loss from operations   (73,529)       (47,978)  
Total other income, net   7,069       1,983  
Loss before equity method investment   (66,460)       (45,995)  
Loss on equity method investment   (470)        
Net loss $ (66,930)     $ (45,995)  
Net loss per share – basic and diluted $ (0.93)     $ (0.85)  
Weighted-average shares – basic and diluted   72,289       53,908  
 
BALANCE SHEET DATA: March  31,
2024
    December  31,
2023
 
           
Cash, cash equivalents and investments $ 900,961     $ 558,555  
Working capital $ 865,461     $ 530,211  
Total assets $ 978,153     $ 635,353  
Total liabilities $ 103,220     $ 96,247  
Accumulated deficit $ (720,632)     $ (653,702)  
Total stockholders’ equity $ 874,933     $ 539,106  
               

Investors:
Corey Davis
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
(212) 915-2577

Media:
Natalie Badillo
Head of Corporate Communications
nbadillo@crinetics.com
(858) 345-6075



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Tempest Reports First Quarter 2024 Financial Results and Provides Business Update By Investing.com

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  • Advancing TPST-1120 into a pivotal Phase 3 trial in first-line HCC and TPST-1495 into a Phase 2 in FAP
  • Reported new preclinical data for TPST-1120 in kidney cancer at the AACR Annual Meeting
  • Published positive data from the Phase 1 Trial of TPST-1120 in patients with advanced solid tumors in the Journal of Cancer Research Communications
  • Presented new data at the SITC 2024 Spring Scientific Meeting elucidating the mechanism of TPST-1120 and supporting its potential in multiple cancers

BRISBANE, Calif., May 09, 2024 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended March 31, 2024, and provided a corporate update.

“The positive data and mechanistic analysis presented in the first quarter build on the positive preclinical and clinical data package for TPST-1120, further confirming and reinforcing our excitement about the potential of TPST-1120 in liver and kidney cancers, as well as other indications, and our confidence in the program as it moves closer to a pivotal Phase 3 study in first-line HCC, said Stephen Brady, president and chief executive officer of Tempest.

Recent Highlights

  • TPST-1120 (clinical PPARα antagonist):
    • Reported new preclinical data at the 2024 American Association for Cancer Research (AACR) Annual Meeting demonstrating that TPST-1120 reduces kidney cancer (RCC) growth as a monotherapy, while also showing increased inhibition when combined with frontline chemotherapy and immunotherapy. These data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.
    • Published positive data from Phase 1 Trial of TPST-1120 in patients with advanced solid tumors in the Journal of Cancer Research Communications. Data showed that TPST-1120 demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor-refractory and immune-compromised cancers, and was well tolerated both as monotherapy and in combination with nivolumab. These data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC.
    • Presented new preclinical data showing potent anti-tumor activity in several cancer models treated with TPST-1120 alone or with immune checkpoint inhibitors at the Society for Immunotherapy of Cancer (SITC) 2024 Spring Scientific Meeting. The presentation also covered experimental results that corroborated clinical biomarker data from patients with advanced solid tumor cancers treated in the Phase 1 clinical trial of TPST-1120 in multiple solid tumor indications, which showed statistically significant, exposure-dependent elevations in expression levels of multiple immune-related genes, and patients exhibiting objective responses displayed increased circulating free fatty acids (FFA), both of which are in-line with the proposed TPST-1120 mechanism of action.

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Potential Future Milestones

  • TPST-1120 (clinical PPARα antagonist)
    • Expect to announce updated data from the ongoing randomized study in first-line HCC patients in 2024.
    • Plan to advance TPST-1120 into a registrational Phase 3 study in first-line HCC patients, subject to obtaining feedback from the FDA.
  • TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
    • Plan to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in 2024 under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention, subject to final approval of NCI.
    • Expect to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer, where prostaglandin signaling is implicated, in 2024.

Financial Results

First Quarter 2024

  • Tempest ended the quarter with $32.3 million in cash and cash equivalents, compared to $39.2 million on December 31, 2023.
  • Net loss and net loss per share for the quarter ended March 31, 2024, were $7.9 million and $0.36, respectively, compared to $7.6 million and $0.55, respectively, for the same period in 2023.
  • Research and development expenses for the quarter were $4.3 million compared to $4.7 million for the same period in 2023. The $0.4 million decrease was primarily due to a decrease in costs incurred from contract research organizations and third-party vendors.
  • General and administrative expenses for the quarter were $3.6 million compared to $2.9 million for the same period in 2023. The $0.7 million increase was primarily due to share-based compensation expenses and consulting services.
  • Based on its current cash and operating plan, Tempest expects to have sufficient resources to fund operations into the second quarter of 2025.

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About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the Securities Act)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as may, will, should, would, could, expect, anticipate, plan, likely, believe, estimate, project, intend, and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials; anticipated therapeutic benefit and regulatory development of the Company’s product candidates; the Company’s anticipated cash runway; the Company’s ability to deliver on potential value-creating milestones; the Company’s ability to advance into a late-stage clinical company; and the Company’s ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the Risk Factors section of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and other documents filed by the Company from time to time with the Securities and Exchange Commission. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.

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TEMPEST THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands)
March 31, 2024 December 31, 2023
Assets
Current assets
Cash and cash equivalents $ 32,326 $ 39,230
Prepaid expenses and other current assets 1,171 1,133
Total current assets 33,497 40,363
Property and equipment, net 920 840
Operating lease right-of-use assets 9,513 9,952
Other noncurrent assets 448 448
Total assets $ 44,378 $ 51,603
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 1,051 $ 845
Accrued expenses 1,524 1,673
Current loan payable, net 6,458 4,285
Current operating lease liabilities 858 952
Accrued compensation 690 1,543
Interest payable 110 113
Total current liabilities 10,691 9,411
Loan payable, net 4,140 6,264
Operating lease liabilities 8,915 9,160
Total liabilities 23,746 24,835
Stockholders’ equity
Common stock 22 22
Additional paid-in capital 193,777 192,009
Accumulated deficit (173,167 ) (165,263 )
Total stockholders’ equity 20,632 26,768
Total liabilities and stockholders’ equity $ 44,378 $ 51,603
TEMPEST THERAPEUTICS, INC.
Consolidated Statements of Operations
(in thousands, except per share amounts)
Three months ended Three months ended
March 31, 2024 March 31, 2023
Expenses:
Research and development $ 4,340 $ 4,678
General and administrative 3,634 2,903
Operating loss (7,974 ) (7,581 )
Other income (expense), net:
Interest expense (368 ) (344 )
Interest and other income, net 438 289
Net loss $ (7,904 ) $ (7,636 )
Net loss per share $ (0.36 ) $ (0.55 )

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Investor Contacts:

Sylvia WheelerWheelhouse Life Science Advisorsswheeler@wheelhouselsa.com

Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@wheelhouselsa.com

___i If approved by the FDA



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Savara Reports First Quarter 2024 Financial Results and Provides Business Update By Investing.com

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  • Pivotal Phase 3 IMPALA-2 Trial Remains On-track, Top Line Results Expected by End of 2Q 2024
    • 48-week placebo-controlled trial is evaluating molgramostim nebulizer solution (molgramostim), a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease
  • Pending Results from the IMPALA-2 Trial, a Biologics License Application (BLA) Filing is Anticipated in 1H 2025
  • With ~$143M in Cash and Short-term Investments, the Company Continues to Believe it is Sufficiently Capitalized into 2026

LANGHORNE, Pa.–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2024 and provided a business update.

The IMPALA-2 trial remains on-track and we look forward to reporting top line results by the end of the second quarter, said Matt Pauls, Chair and CEO, Savara (NASDAQ:). Following that, and assuming positive data, we expect to file a BLA in the first half of 2025. Importantly, with $143 million in cash and investments, we believe we are capitalized into 2026 which is well beyond the data read-out and includes investments in programs such as the extension of the IMPALA-2 open-label period from 48 weeks to 96 weeks, anticipated launch of a global Expanded Access program for molgramostim, build out of the U.S. Commercial infrastructure, and pre-Commercial preparations in Europe.

First Quarter Financial Results (Unaudited)

Savara’s net loss for the first quarter of 2024 was $20.3 million, or $(0.11) per share, compared with a net loss of $10.6 million, or $(0.07) per share, for the first quarter of 2023.

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Research and development expenses increased by $8.1 million, or 92.3%, to $16.8 million for the three months ended March 31, 2024 from $8.7 million for the three months ended March 31, 2023. The increase was largely due to the performance of tasks related to the molgramostim program, which included approximately $4.3 million associated with chemistry, manufacturing, and controls activities and primarily driven by initiatives at second source drug substance manufacturers, $1.0 million related to the IMPALA-2 clinical trial, including clinical research organization (CRO) related activities, $0.6 million associated with regulatory affairs and quality assurance work, and $2.2 million due to an increase in personnel and related costs.

General and administrative expenses increased by $2.3 million, or 67.4%, to $5.6 million for the three months ended March 31, 2024 from $3.4 million for the three months ended March 31, 2023. The increase was due to personnel and related costs of $0.6 million, certain commercial activities of $1.1 million, and other overhead of $0.6 million primarily driven by patient advocacy activities.

As of March 31, 2024, the Company had cash, cash equivalents and short-term investments of approximately $143.0 million and debt of approximately $26.4 million.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow ® Nebulizer System (PARI Pharma GmbH). Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com. (X, formerly known as Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).

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Forward-Looking Statements

Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as expect, intend, plan, anticipate, believe, and will, among others. Such statements include, but are not limited to, statements related to the expected timing of reporting top line data from the IMPALA-2 trial, the anticipated timing of the BLA filing, our belief the Company is capitalized into 2026, and the planned investments in the extension of the IMPALA-2 open label period, the anticipated launch of a global Expanded Access program, the build out of the U.S. Commercial infrastructure, and pre-Commercial preparations in Europe. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks and uncertainties relating to the impact of widespread health concerns impacting healthcare providers or patients, disruptions or inefficiencies in the supply chain and geopolitical conditions, the outcome of our ongoing and planned clinical trials for our product candidate, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to successfully develop our product candidate, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as molgramostim that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

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Financial Information to Follow

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except for share and per share amounts)

Unaudited

Three months ended

March 31,

2024

2023

Operating expenses:
Research and development

$

16,807

$

8,738

General and administrative

5,636

3,366

Depreciation and amortization

32

8

Total operating expenses

22,475

12,112

Loss from operations

(22,475

)

(12,112

)

Other income (expense), net:

2,129

1,555

Net loss attributable to common stockholders

$

(20,346

)

$

(10,557

)

Net loss per share – basic and diluted

$

(0.11

)

$

(0.07

)

Weighted average shares – basic and diluted

182,550,109

152,781,580

Other comprehensive (loss) gain

(471

)

144

Total comprehensive loss

$

(20,817

)

$

(10,413

)

Savara Inc. and Subsidiaries

Condensed Consolidated Balance Sheet Data

(in thousands)

(Unaudited)

March 31,

December 31,

2024

2023

Cash, cash equivalents, and short-term investments

$

143,043

$

162,319

Working capital

136,377

155,350

Total assets

158,295

177,564

Total liabilities

36,434

37,192

Stockholders’ equity:

121,861

140,372

Savara Inc. IR&PR
Anne Erickson (anne.erickson@savarapharma.com)
(512) 851-1366

Source: Savara Inc.



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Wipro Infrastructure Engineering’s Hydraulics Business enters into a definitive agreement to acquire Mailhot Industries By Investing.com

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BANGALORE, India–(BUSINESS WIRE)–Wipro Hydraulics, the hydraulic cylinders and components manufacturing business of Wipro (NYSE:) Infrastructure Engineering, announced it has entered into a definitive agreement to acquire Mailhot Industries, a Novacap portfolio company, headquartered in Quebec, Canada, subject to customary closing conditions including regulatory approvals.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240508985521/en/

Mailhot Industries Facility in Quebec, Canada (Photo: Business Wire)

Established in 1956, Mailhot Industries has become a North American leader in hydraulic cylinder manufacturing. Mailhot Industries specializes in the refuse trucks and snow removal equipment market and is known for the reliability of their products in demanding work environments. The acquisition also includes JARP Industries, a part of Mailhot Industries and a leader in custom hydraulic and remanufactured cylinders for segments including utilities, mining, defense, and oil & gas.

Commenting on the acquisition, Mr. Pratik Kumar, CEO, Wipro Infrastructure Engineering (WIN) & Managing Director, Wipro Enterprises, said, Wipro Hydraulics stands as one of the world’s largest independent hydraulic cylinder manufacturers, delivering over one million cylinders to OEMs globally. This acquisition marks a pivotal moment for us, further bolstering our market position by integrating new technologies and expanding our global footprint. This strategic move will complement our capabilities and strengthen our leadership position in the North American market.

Mr. Charles Massicotte, President, Mailhot Industries, said, The expertise and reputation of Mailhot in the North American Hydraulic Cylinder market combined with Wipro’s globally recognized leadership in manufacturing and technology will broaden Mailhot’s offerings in North America and open new international markets for existing products. We are convinced that by partnering with Wipro, Mailhot is destined to become an even bigger player in the global hydraulic cylinder market and reinforce its leadership position in North America. We are proud to be part of such a recognized global company, it is a new day for Mailhot, and it is looking bright!

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Mr. Sitaram Ganeshan, President, Wipro Hydraulics, said, With this acquisition of Mailhot, we will expand our footprint to Canada, the US, and Mexico, as well as penetrate new segments like refuse trucks, snow removal equipment, defense, and remanufacturing in North America. This also allows us to increase our capabilities in existing segments such as utilities and mining, positioning us to serve our customers better. Together, we will have an increased presence and offer a wider portfolio of products and technologies to our customers.

Mr. Michel Toutant, Senior Partner, Novacap, said, It has been an honor to be part of this incredible growth journey with the entire management team. Wipro is the perfect partner to bolster Mailhot’s next phase of growth as it seeks to expand its foothold in North America. I look forward to seeing Mailhot continue to flourish under Wipro’s ownership.

About Wipro Infrastructure Engineering

Wipro Infrastructure Engineering, a part of Wipro Enterprises, is a diversified business with expertise spanning over four decades of engineering and manufacturing excellence in Hydraulics, Industrial Automation, Aerospace, Water Treatment, and Additive Manufacturing. The Wipro Hydraulics Business specializes in designing and manufacturing custom-built Hydraulic Cylinders for applications in diverse segments such as Construction & Earthmoving, Material & Cargo Handling, Forestry, Farm & Agriculture, Mining, and Truck Tipping Solutions. Additionally, Wipro Hydraulics operates 11 manufacturing facilities globally, further enhancing its capacity and reach.

For more information visit www.wiproinfra.com

About Mailhot Industries

A North American leader in hydraulic cylinders manufacturing since 1956, Mailhot Industries is known for the reliability of its products in sectors of activity where the work environment is difficult and even extreme. Recognized for the excellence of its products, its innovations, and its impeccable after-sales service, Mailhot relies on the expertise of 500 employees to meet the specific needs and requirements of their customers. Over the last few years, Mailhot’s impressive growth has been supported, among other things, by the development of unique and innovative processes that provide increased wear and corrosion resistance to cylinders.

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For more information visit www.mailhotindustries.com

About Novacap

Founded in 1981, Novacap is a leading North American private equity firm with over C$8B of AUM that has invested in more than 100 platform companies and completed more than 150 add-on acquisitions. Applying its sector-focused approach since 2007 in Industries, ™T, Financial Services, and Digital Infrastructure, Novacap’s deep domain expertise can accelerate company growth and create long-term value. With experienced, dedicated investment and operations teams as well as substantial capital, Novacap has the resources and knowledge that help build world-class businesses. Novacap has offices in Montreal, Toronto, and New York.

For more information, please visit www.novacap.ca.

Contact for more information (India & Europe): Sahifa Mehta : +91 98 99 111 209
(North America, Canada, Mexico): Thomas H Steger Jr. : +1 (931) 260-8495

Source: Wipro Infrastructure Engineering



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SYLA Receives the Business Award for ZEH-M Oriented Certification and Integration of Energy-Saving Technologies By Investing.com

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TOKYO, May 09, 2024 (GLOBE NEWSWIRE) — SYLA Technologies Co., Ltd. (NASDAQ: SYT) (SYLA or the Company), operator of the largest membership real estate crowdfunding platform in Japan, Rimawari-kun, announced that its wholly-owned subsidiary,  SYLA Co., Ltd., (Representative Director: Yoshiyuki Yuto) (SYLA Co.), has been honored with the Excellent Business Award in the mid- to high-rise studio condominium category by the Japan Association of Home Suppliers for its brand condominium, SYFORME MOTOMACHI-CHUKAGAI (the Property), completed in December 2023.

Background of the Award for the Property as an Environmentally Friendly InitiativeThe Japan Association of Home Suppliers sponsors the Excellent Business Awards to recognize outstanding projects by its members, aiming to promote the provision of high-quality housing and living environments while contributing to the sustainable growth of the housing and real estate industry and enhancing the standards of its members. SYLA Co.’s brand condominium, SYFORME MOTOMACHI-CHUKAGAI, was honored with the Excellent Business Award in the mid- to high-rise studio condominium sales category.

The Property holds ZEH-M Oriented certification, emphasizing environmental protection and disaster preparedness. Through enhancements in insulation performance and the installation of energy-saving equipment, the Property has achieved a 34% reduction in primary energy consumption. Furthermore, solar power generation and storage battery facilities have been installed to contribute to environmental conservation, address the challenge of escalating electricity prices, and secure a reliable emergency power supply in times of disaster.

While progress toward carbon neutrality via ZEH certification and solar power integration is underway, introducing such features in mid- and high-rise studio condominium projects has been challenging. The main challenges include limited rooftop space for installation, installation complexities, and high installation and management costs. To overcome these obstacles, SYLA Co. has strategically combined energy conservation, generation, and storage technologies to create value-added, environmentally friendly products that also enhance disaster resilience.

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About the award-received propertyProperty name: SYFORME MOTOMACHI-CHUKAGAIAddress: 2-11-40 Shinyamashita, Naka-ku, Yokohama City, KanagawaBuilder: SYLA Co., Ltd.Seller: SYLA Co., Ltd.Construction: Fuetsu Construction Co., Ltd.Planning and supervision: AsakuraTakaoToshikenchikusekkei Co., Ltd.Design supervision: Base Co., Ltd.Completion date: December 22, 2023Site area: 1,171.89m2Total floor area: 3,354.90m2Unit area: 24.13m2 “ 25.74m2Structure: Reinforced concrete, 6 floors above the groundNumber of residential units: 95

About SYLA Technologies Co., Ltd.Headquartered in Tokyo, Japan, SYLA Technologies Co., Ltd. (NASDAQ: SYT) (SYLA or the Company) owns and operates the largest membership real estate crowd-funding platform in Japan, Rimawari-kun, which targets individuals, corporate and institutional investors, as well as high net worth individuals. SYLA’s mission is to democratize real estate investment around the world through technology and asset management through the Rimawari-kun platform. SYLA is engaged in the overall investment condominium business, including planning, development, construction, sales, rental management, building management, repair work, and the sale of properties. Additional information about the Company’s products and services is available at  https://syla-tech.jp/en.

Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as expects, anticipates, intends, plans, believes, seeks, estimates and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the expected gross proceeds and the closing of the offering. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (SEC), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F, filed with the SEC on April 18, 2023. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release.

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.Contact InformationSYLA Technologies Investor Relations Contact:Gateway Group, Inc.John Yi and Steven ShinmachiSYLA@gateway-grp.com(949) 574-3860SYLA Technologies Company Contact:Takeshi FuchiwakiDirector, Chief Growth Officerirpr@syla.jp



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ARLO TECHNOLOGIES HONORED AS GOLD STEVIE ® AWARD WINNER IN 2024 AMERICAN BUSINESS AWARDS ® By Investing.com

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Arlo received highest award honor within the Innovation of the Year, Consumer Products Industries category

SAN JOSE, Calif., May 9, 2024 /PRNewswire/ — Arlo Technologies (NYSE:), Inc. (NYSE: ARLO), a leading smart home security brand, proudly announces it has been named a Gold Stevie ® Award winner in the Innovation of the Year – Consumer Products Industries category in The 22nd Annual American Business Awards ®. As the only smart home security brand in the Consumer Products category to receive a Stevie Award, the recognition speaks to Arlo’s ongoing innovation and dedication to providing customers with a robust ecosystem of award-winning hardware, software, and services.

The American Business Awards are the U.S.A.’s premier business awards program. All organizations operating in the U.S.A. are eligible to submit nominations “ public and private, for-profit and non-profit, large and small. More than 3,700 nominations from organizations of all sizes and in virtually every industry were submitted this year for consideration in a wide range of categories. More than 300 professionals worldwide participated in the judging process to select this year’s Stevie Award winners.

Arlo was recognized for its significant business achievements and strong growth record in 2023, including surpassing 2 Million paid subscribers, debuting innovative new products and services, and receiving more than 25 awards and editorial recognitions from leading organizations.

“Arlo has achieved major milestones in 2023, which led to this incredible honor of receiving a Gold Stevie Award,” said Matthew McRae, CEO of Arlo. “This award is a testament to the hard work and dedication of our team at Arlo. We’re incredibly grateful for the recognition and will continue to innovate and deliver top-notch products and services to our customers.”

“While growth in much of the world economy has recovered slowly from the COVID-19 pandemic, the American economy continues to show remarkable resilience and growth,” said Stevie Awards president Maggie Miller. “Our 2024 Stevie winners have contributed to that successful recovery through their innovation, persistence, and hard work.   We congratulate all our winners in the 2024 ABAs and look forward to celebrating their achievements during our June 11 awards banquet in New York.”

Details about The American Business Awards and the list of 2024 Stevie winners are available at  www.StevieAwards.com/ABA.

About Arlo Technologies, Inc.
Arlo is an award-winning, industry leader that is transforming the ways in which people can protect everything that matters to them with advanced home, business, and personal security solutions. Arlo’s deep expertise in AI- and CV-powered analytics, cloud services, user experience and product design, and innovative wireless and RF connectivity enables the delivery of a seamless, smart security experience for Arlo users that is easy to set up and interact with every day. Arlo’s cloud-based platform provides users with visibility, insight, and a powerful means to help protect and connect in real-time with the people and things that matter most, from any location with a Wi-Fi or a cellular connection. To date, Arlo has launched several categories of award-winning connected devices, software, and services. These include wire-free, smart Wi-Fi and LTE-enabled security cameras, video doorbells, floodlights, security system, and Arlo’s subscription services: Arlo Secure and Arlo Safe.

With a mission to bring users peace of mind, Arlo is as passionate about protecting user privacy as it is about safeguarding homes and families. Arlo is committed to implementing industry standards for data protection designed to keep users’ personal information private and in their control. Arlo provides enhanced controls for user data, supports privacy legislation, keeps user data safely secure, and puts security at the forefront of company culture.

About the Stevie Awards
Stevie Awards are conferred in nine programs: the Asia-Pacific Stevie Awards, the German Stevie Awards, the Middle East & North Africa Stevie Awards, The American Business Awards ®, The International Business Awards ®, the Stevie Awards for Women in Business, the Stevie Awards for Great Employers, the Stevie Awards for Sales & Customer Service, and the new Stevie Awards for Technology Excellence. Stevie Awards competitions receive more than 12,000 entries each year from organizations in more than 70 nations. Honoring organizations of all types and sizes and the people behind them, the Stevies recognize outstanding performances in the workplace worldwide. Learn more about the Stevie Awards at  http://www.StevieAwards.com.

Supporting sponsors of The 2024 American Business Awards include Melissa Sones Consulting and SoftPro.

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HOOKIPA Pharma Reports First Quarter 2024 Financial Results  and Recent Business Highlights By Investing.com

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  • Phase  2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligns with U.S. Food and Drug Administration (FDA) feedback
  • HB-200 program received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA)
  • Received FDA clearance for Investigational New Drug (IND) application for HB-700 for the treatment of KRAS mutated cancers    

NEW YORK and VIENNA, May 09, 2024 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (NASDAQ: HOOK, ˜HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and recent business highlights for the first quarter of 2024.

The first quarter was about focus at HOOKIPA. We are embarking on a pivotal trial for HB-200 in combination with pembrolizumab and made important decisions to align our organization for late-stage clinical trial execution. We also added to the depth of our executive team with a new Chief Development Officer, Mark Winderlich, who brings crucial experience to help us execute on our clinical development strategy, said Joern Aldag, Chief Executive Officer of HOOKIPA. We have made great progress and have an FDA-aligned pivotal Phase  2/3 trial design that is patient-centric and we believe has a high probability of success. Our path forward is clear, and the team is excited to take a major step on our path to deliver better outcomes for patients.

Business Highlights and Recent Developments

Oncology

  • HOOKIPA is preparing to start a seamless pivotal Phase  2/3 trial of HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ‰¥ 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting.
    • The Phase 2/3 trial design and protocol are based on alignment with the FDA following the Company’s Type C meeting.
    • EMA granted PRIME designation to the investigational product HB-200 in combination with pembrolizumab. PRIME designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. Eligibility and approval are based on preliminary clinical evidence and indicate that the drug candidate may offer substantial improvement over existing therapies.
    • The Company anticipates the first patient will be enrolled in the fourth quarter of 2024. HB-200 was accepted for an oral abstract presentation at the ASCO 2024 Annual Meeting with data from approximately 40  patients treated with HB-200 in combination with pembrolizumab.
  • The HB-700 program is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers. The Company received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700 for the treatment of KRAS-mutated cancers. Effective April  25, 2024, HOOKIPA regained full control of the associated intellectual property portfolio and has full collaboration and licensing rights for this program.

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Infectious Disease

  • HB-400 is currently being evaluated in a Phase  1 trial and is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences, Inc. (NASDAQ:) (Gilead). Gilead is solely responsible for further development and commercialization of the HBV product candidate.
  • HB-500 is an investigational therapeutic vaccine for the treatment of human immunodeficiency virus (HIV), also partnered with Gilead. HOOKIPA received FDA clearance of its IND application in the fourth quarter of 2023 and expects to initiate a Phase  1 clinical trial of HB-500 in people with HIV in the second quarter of 2024. Under the collaboration agreement with Gilead, HOOKIPA is eligible for a milestone payment upon dosing the first patient in this trial.

Corporate and Financial Updates

Corporate Highlights

  • On January  29, 2024, HOOKIPA provided an update on its business priorities and oncology partnership programs. The Company announced that it will focus its resources in two strategic areas: (1) the clinical development of a randomized trial for its HB-200 program and (2) its two Gilead-partnered infectious disease cure programs for hepatitis B and HIV.
  • Mark Winderlich, Ph.D., joined the Company on April  1,  2024, as Chief Development Officer to lead HOOKIPA’s clinical research and development organization.

Financial Highlights

  • HOOKIPA received a final $10.0  million milestone payment under its now-terminated HB-700 collaboration agreement with Roche. The success-based milestone payment was achieved in connection with HOOKIPA’s submission of an IND application for HB-700 for the treatment of KRAS mutated tumors.
  • Total revenues of $36.6 million, mainly driven by the recognition of previously received upfront and milestone payments under the now-terminated Roche collaboration, as well as the recent HB-700 milestone achievement, led to a profitable first quarter of 2024.

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Anticipated Catalysts & Milestones

Program Indication Upcoming Anticipated Catalysts
Oncology Programs
HB-200 HPV16+ HNSCC
  • Additional Phase  2 first-line data for HB-200 in combination with pembrolizumab (ASCO 2024)
  • Pivotal study start (4Q 2024)
HB-700 KRAS
  • Publication of preclinical data (ASCO 2024)
Infectious Disease Programs: Gilead-Partnered
HB-400 HBV
  • Gilead-led: Phase  1b actively enrolling
  • Next milestone: Initiation of Phase  2
    (timing determined by Gilead)
HB-500 HIV
  • Initiation of Phase  1 trial; first patient dosed and associated milestone payment (2Q 2024)

First Quarter 2024 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31,  2024 was $93.0  million compared to $117.5  million as of December  31,  2023. The decrease was primarily attributable to cash used in operating activities.

Revenue: Revenue was $36.6  million for the three months ended March  31,  2024, compared to $3.2  million for the same period in 2023. The increase was primarily due to higher partial revenue recognition under the Roche collaboration as a result of the termination of the agreement, leading to accelerated recognition of the upfront and milestone payments that were initially recorded as deferred revenue.

Research and Development Expenses: HOOKIPA’s research and development expenses were $20.2  million for the three months ended March  31,  2024, compared to $20.9  million for the same period in 2023. The primary drivers of the decrease in research and development expenses were lower personnel-related and laboratory-related expenses, partially offset by higher clinical study expenses for the HB-200 program.

General and Administrative Expenses: General and administrative expenses amounted to $4.1  million for the three months ended March  31,  2024, compared to $4.9  million for the same period in 2023. The primary driver of the decrease in general and administrative expenses was a decrease in personnel-related expenses.

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Restructuring Expenses: Restructuring expenses amounted to $1.3  million for the three months ended March  31,  2024, and resulted from severance and other personnel costs as well as consulting costs associated with the Company’s restructuring plan announced in January  2024.

Net Income (Loss): HOOKIPA’s net income was $14.4  million for the three months ended March  31,  2024, compared to a net loss of $19.7  million for the same period in 2023. This increase was primarily due to the accelerated recognition of upfront and milestone payments under the Roche collaboration.

HOOKIPA Pharma Inc.
Consolidated Statements of Operations (Unaudited)
(In thousands, except share and per share data)

    Three months ended
March 31,
    2024   2023
Revenue from collaboration and licensing   $ 36,599     $ 3,176  
Operating expenses:                
Research and development     (20,168 )     (20,931 )
General and administrative     (4,056 )     (4,902 )
Restructuring     (1,269 )      
Total operating expenses     (25,493 )     (25,833 )
Income (loss) from operations     11,106       (22,657 )
Total interest, other income and taxes, net     3,277       2,977  
Net income (loss)   $ 14,383     $ (19,680 )
Net income (loss) per share            
Basic   $ 0.11     $ (0.27 )
Diluted   $ 0.11     $ (0.27 )
                 

Condensed Balance Sheets
(In thousands)

  As  of         As  of
  March  31,   December  31,
  2024   2023
Cash, cash equivalents and restricted cash $ 92,955   $ 117,521
Total assets   145,871     161,337
Total liabilities   41,349     71,480
Total stockholders’ equity   104,522     89,857
           

About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T  cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, KRAS-mutated cancers, and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.  

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Find out more about HOOKIPA online at  www.hookipapharma.com.

Forward Looking Statements

Certain statements set forth in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as anticipates, believes, expects, plans, potential, will, would or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA’s statements regarding the potential of its product candidates to positively impact quality of life and alter the course of disease in the patients it seeks to treat, HOOKIPA’s plans, strategies, expectations and anticipated milestones for its preclinical and clinical programs, including the timing of initiating clinical trials and patient enrollment, the availability and timing of results from preclinical studies and clinical trials, the timing of regulatory filings, the expected safety profile of HOOKIPA’s product candidates, and the probability of successfully developing and receiving regulatory approval for its product candidates. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs, the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for HB-200, HB-700, HB-400 and HB-500, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property,  risks relating to business interruptions resulting from public health crises, the impact of public health crises on the enrollment of patients and timing of clinical results, HOOKIPA’s ability to achieve the expected benefits of its strategic reprioritization and other matters that could affect the sufficiency of existing cash to fund  operations. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see HOOKIPA’s Annual Report on Form 10-K for the year ended December  31,  2023, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA’s subsequent filings with the Securities and Exchange Commission, which are available on the SEC’s website at  https://sec.gov and HOOKIPA’s website at  www.hookipapharma.com. All information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law.

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Availability of Other Information About HOOKIPA

Investors and others should note that we announce material financial information to our investors using our investor relations website, www.ir.hookipapharma.com, SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our investors and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the social media channels listed on our investor relations website.

For further information, please contact:

Investors & Media
Michael Kaiser
michael.kaiser@hookipapharma.com
+1 (917) 984 7537

 



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MindMed Reports First Quarter 2024 Financial Results and Business Updates By Investing.com

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–Announced positive Phase 2b clinical trial results for MM120 in Generalized Anxiety Disorder (GAD), demonstrating clinically and statistically significant activity through 12 weeks after treatment–

–The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MM120 for the treatment of GAD in adults–

–Cash and cash equivalents of $252.3 million as of March 31, 2024–

–Company to host a conference call today at 4:30 p.m. EDT–

NEW YORK–(BUSINESS WIRE)–Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the quarter ended March 31, 2024, and provided a business update.

Building on a highly productive 2023, we were pleased to start the year by announcing that our Phase 2b trial of MM120 in GAD hit its key secondary endpoint with clinically and statistically significant activity observed through Week 12 of the study, said Rob Barrow, Chief Executive Officer of MindMed. Additionally, the results we shared from our Phase 1 pharmacokinetics bridging trial support the advancement of our MM120 oral dissolving tablet (ODT) formulation into pivotal clinical trials, with our Phase 3 program of MM120 in GAD on track to initiate in the second half of 2024. We also presented at several recent medical meetings highlighting the continued unmet need, burden and increasing prevalence of GAD. With a strong balance sheet expected to fund operations through numerous key milestones, we look forward to providing additional updates on our GAD program, as well as on our pipeline as we advance MM402 for the treatment of autism spectrum disorder (ASD), and potentially expand into additional indications for MM120.

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.

Business Update

  • The Company completed an underwritten offering and concurrent private placement for $175.0 million in gross proceeds before deducting transaction fees and other offering related expenses.
  • The Company voluntarily delisted its common shares from Cboe Canada. The Company’s common shares continue to be listed and tradable on Nasdaq under the symbol MNMD.

Program Updates and Anticipated Milestones

MM120 (lysergide D-tartrate) for GAD

  • In March 2024, the Company announced that FDA granted Breakthrough Therapy Designation (BTD) to MM120 for the treatment of GAD in adults.
  • In March 2024, the Company announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint with data demonstrating rapid, robust, and durable activity, which was clinically and statistically significant through Week 12.
    • MM120 100 µg “ the dose with optimal clinical activity observed in the trial “ demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p
    • Clinical Global Impressions – Severity (CGI-S) scores, on average, improved from 4.8 to 2.2 in the 100- µg dose group, representing a two-category shift from ˜markedly ill’ to ˜borderline ill’ at Week 12 (p
    • MM120 was generally well-tolerated in the trial, with most adverse events rated as mild to moderate, transient, occurring on dosing day, and consistent with expected acute effects of the study drug.
  • In March 2024, the Company announced results from its pharmacokinetics (PK) bridging study to support the advancement of the MM120 Zydis ® oral dissolving tablet (ODT) formulation into pivotal clinical trials.
    • In the trial, the Zydis ® ODT formulation demonstrated 50% faster onset of action and meaningful improvements in both the overall area under the curve and the area under the curve above target or therapeutic concentrations compared to the non ODT formulation.
    • We believe the Zydis ® ODT formulation offers numerous product performance, clinical, and intellectual property benefits.
  • The Company presented detailed results from its Phase 2b study of MM120 in GAD, as well as multiple presentations describing the epidemiology and growing burden of GAD at the following conferences:
    • European Psychiatric Association (EPA) 2024 Congress
    • Anxiety & Depression Association of America (ADAA) 2024 Conference
    • American Psychiatric Association (APA) 2024 Congress
    • International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2024
  • One-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders will be presented at the Society of Biological Psychiatry (SOBP) 2024 Annual Meeting being held May 9-11 in Austin, Texas.
    • This trial was conducted by the Company’s collaborators at University Hospital Basel (UHB) in Switzerland and extends on the previously reported positive findings from the LSD-Assist study presented in May 2022.
  • The Company plans to hold an End-of-Phase 2 meeting with FDA in the second quarter[DK1] of 2024 and is on track to initiate its Phase 3 clinical program of MM120 Zydis ® ODT for the treatment of GAD in the second half of 2024.

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MM402 (R(-)-MDMA) for ASD

  • The Company initiated its first clinical trial of MM402 (R(-)-MDMA), a single-ascending dose trial in adult healthy volunteers in Q4 2023. This Phase 1 trial is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM402. It should enable further clinical trials to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population.
  • UHB has conducted a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA in healthy adult volunteers. This trial was designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. Topline results are anticipated to be presented in the second quarter of 2024.

First Quarter 2024 Financial Results

Cash Balance. As of March 31, 2024, MindMed had cash and cash equivalents totaling $252.3 million compared to $99.7 million as of December 31, 2023. The Company believes its available cash and cash equivalents will be sufficient to fund its operations into 2026 based on its current operating plan.

Net Cash Used in Operating Activities. For the quarter ended March 31, 2024, net cash used in operating activities was $16.6 million, compared to $13.3 million in the quarter ended March 31, 2023.

Research and Development (R&D). R&D expenses were $11.7 million for the quarter ended March 31, 2024, compared to $12.6 million for the quarter ended March 31, 2023, a decrease of $0.9 million. The decrease was primarily due to decreases of $0.6 million in expenses related to our MM402 program, a decrease of $0.5 million in expenses related to preclinical activities, partially offset by an increase of $0.3 million in internal personnel costs as a result of increasing research and development capacities.

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General and Administrative (G&A). G&A expenses were $10.5 million for the quarter ended March 31, 2024, compared to $8.3 million for the quarter ended March 31, 2023, an increase of $2.2 million. The increase was primarily attributable to increased stock-based compensation expense of $1.1 million and an increase of $0.7 million in personnel-related expenses due to an increase in headcount to support the growth of our business.

Net Loss. Net loss for the quarter ended March 31, 2024 was $54.4 million, compared to $24.8 million for the quarter ended March 31, 2023. The increase was primarily due to changes in the fair value of 2022 USD Financing Warrants of $27.7 million.

CFO Transition

On May 3, 2024, the Company made a transition in the role of Chief Financial Officer resulting in the departure of Schond Greenway. On behalf of the Board of Directors and Executive team, I would like to thank Schond for all his hard work and dedication over the past two years, said Robert Barrow, Chief Executive Officer and Director of MindMed. Schond supported the Company through several significant milestones and has left us well positioned financially and strategically. As we continue to progress our development pipeline and advance preparations for the potential commercialization of MM120, we are committed to identifying leaders that will continue the Company’s recent momentum and deliver long-term value to shareholders.

MindMed has retained an executive search firm to assist in identifying a new Chief Financial Officer.

Conference Call and Webcast Reminder

MindMed management will host a conference call at 4:30 PM EDT today to provide a corporate update and review the Company’s first quarter 2024 financial results. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the MindMed website, https://ir.mindmed.co/, and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time.

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About MM120

Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and other psychiatric indications.

About MM402

MM402 is our proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), which we are developing for the treatment of core symptoms of ASD. MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer.

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company’s belief that results from its Phase 1 pharmacokinetics bridging trial will support the advancement of its MM120 ODT formulation into pivotal clinical trials; the Company’s belief that it is on track to initiate a Phase 3 clinical program for MM120 Zydis ® ODTs in the second half of 2024; the Company’s plans to provide additional updates on its GAD program and other product candidates in its pipeline; the Company’s beliefs regarding potential benefits of its product candidates; the Company’s plans to hold an End-of-Phase 2 meeting with the FDA in the second quarter of 2024; the Company’s belief that its Phase 1 trial for MM402 (R(-)-MDMA) should enable further clinical trials to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population; the Company’s expectation that topline results from UHB’s Phase 1 investigator-initiated clinical trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA will be presented in the second quarter of 2024; the Company’s expectation that its cash and cash equivalents are expected to fund operations into 2026; anticipated upcoming milestones, trials and studies; results and timing of and reporting of data from clinical trials; and potential additional indications for MM120 and MM402. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 under headings such as “Special Note Regarding Forward-Looking Statements,” and “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.

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Mind Medicine (MindMed) Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except share and per share amounts)

Three Months

Ended March 31,

2024

2023

Operating expenses:

Research and development

$

11,705

$

12,599

General and administrative

10,499

8,263

Total operating expenses

22,204

20,862

Loss from operations

(22,204

)

(20,862

)

Other income/(expense):

Interest income

1,656

1,360

Interest expense

(434

)

(76

)

Foreign exchange loss, net

(525

)

(52

)

Change in fair value of 2022 USD Financing Warrants

(32,893

)

(5,185

)

Total other expense, net

(32,196

)

(3,953

)

Net loss

(54,400

)

(24,815

)

Other comprehensive loss

Gain on foreign currency translation

493

14

Comprehensive loss

$

(53,907

)

$

(24,801

)

Net loss per common share, basic and diluted

$

(1.14

)

$

(0.65

)

Weighted-average common shares, basic and diluted

47,860,757

38,077,251

Mind Medicine (MindMed) Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share amounts)

March 31, 2024

(unaudited)

December 31,

2023

Assets

Current assets:

Cash and cash equivalents

$

252,332

$

99,704

Prepaid and other current assets

3,139

4,168

Total current assets

255,471

103,872

Goodwill

19,918

19,918

Intangible assets, net

527

Other non-current assets

144

224

Total assets

$

275,533

$

124,541

Liabilities and Shareholders’ Equity

Current liabilities:

Accounts payable

$

7,595

$

4,136

Accrued expenses

9,974

11,634

2022 USD Financing Warrants

47,700

16,476

Total current liabilities

65,269

32,246

Credit facility, long-term

14,190

14,129

Other liabilities, long-term

15

32

Total liabilities

79,474

46,407

Shareholders’ Equity:

Common shares, no par value, unlimited authorized as of March 31, 2024 and December 31, 2023; 71,163,720 and 41,101,303 issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

Additional paid-in capital

539,823

367,991

Accumulated other comprehensive income

836

343

Accumulated deficit

(344,600

)

(290,200

)

Total shareholders’ equity

196,059

78,134

Total liabilities and shareholders’ equity

$

275,533

$

124,541

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For Media: media@mindmed.co
For Investors: ir@mindmed.co

Source: MindMed



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Pharvaris Reports First Quarter 2024 Financial Results and Provides Business Update By Investing.com

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  • RAPIDe-3, a global pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, currently enrolling
  • End-of-Phase 2 meeting scheduled to discuss development plan of deucrictibant for the prophylaxis of HAE attacks
  • Executing from a strong financial position with cash and cash equivalents of €368 million as of March 31, 2024

ZUG, Switzerland, May 08, 2024 (GLOBE NEWSWIRE) — Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

Pharvaris is executing from a position of financial and operational strength as we enroll in RAPIDe-3, our Phase 3 on-demand study of deucrictibant, and prepare for initiation of CHAPTER-3, our Phase 3 prophylactic study of deucrictibant, said Berndt Modig, Chief Executive Officer of Pharvaris. We believe deucrictibant has the potential to be the preferred therapeutic option for both the treatment and prevention of HAE attacks. Pharvaris continues to further build its team and infrastructure to support two late-stage clinical trials and prepare for the commercial launch of deucrictibant for people living with HAE.

Recent Business Updates and Highlights

Development Pipeline

  • Enrollment initiated in RAPIDe-3 (NCT06343779) a global Phase 3 clinical study. Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks. The primary efficacy endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) rating of at least a little better for two consecutive timepoints within 12 hours post-treatment. Other efficacy endpoints include time to End of Progression (EoP) in attack symptoms within 12 hours as measured by PGI-C, substantial symptom relief, and proportion of attacks achieving symptom resolution with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S) and by Angioedema Symptom Rating Scale (AMRA).
  • End-of-Phase 2 meeting scheduled to align on prophylactic Phase 3 clinical development plan. Pharvaris continues preparatory activities for CHAPTER-3, a proposed global Phase 3 study of deucrictibant extended-release tablets (PHVS719) for the prophylactic treatment of HAE attacks. An End-of-Phase 2 meeting has been scheduled with the U.S. Food and Drug Administration (FDA), during which Pharvaris will seek feedback and alignment on the key elements of the proposed clinical development plan.

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Corporate

  • Departure of Chief Legal Officer. Joan Schmidt, J.D., Chief Legal Officer of Pharvaris, has given notice of her resignation, effective June 1, 2024. David Nassif, J.D., Chief Financial Officer of Pharvaris, will assume oversight of the legal and compliance department and will act as the corporate secretary until a successor joins the company.
    Mr. Modig continued, I thank Joan for her leadership and contributions to Pharvaris’ growth during her time at the company. We wish her the best in her future endeavors.

Upcoming Investor Presentations

The Citizens JMP Life Sciences Conference. New York, NY, May 13-14, 2024.

  • Format: Fireside Chat
    Presenter: Morgan Conn, Ph.D.
    Date, time: Monday May 13, 2024, 9:30 a.m. EDT

BofA Securities Health Care conference 2024. Las Vegas, NV, May 14-16, 2024.

  • Format: Company Presentation
    Presenter: Morgan Conn, Ph.D.
    Date, time: Thursday May 16, 2024, 8:00 a.m. PDT (11:00 a.m. EDT)

Live audio webcasts of the presentations will be available on the Investors section of the Pharvaris website at:  https://ir.pharvaris.com/news-events/events-presentations. The audio replays will be available on Pharvaris’ website for 30 days following the presentation.

Financials

First Quarter 2024 Financial Results

  • Liquidity Position. Cash and cash equivalents were €368 million as of March 31, 2024, compared to €391 million for December 31, 2023.
  • Research and Development (R&D) Expenses. R&D expenses were €18.5 million for the quarter ended March 31, 2024, compared to €13.7 million for the quarter ended March 31, 2023.
  • General and Administrative (G&A) Expenses. G&A expenses were €9.8 million for the quarter ended March 31, 2024, compared to €7.3 million for the quarter ended March 31, 2023.
  • Loss for the year. Loss for the first quarter was €28.0 million, resulting in basic and diluted loss per share of €0.52 for the quarter ended March 31, 2024, compared to €22.6 million, or basic and diluted loss per share of €0.67, for the quarter ended March 31, 2023.

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Note on International Financial Reporting Standards (IFRS)

Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency.

About Deucrictibant

Deucrictibant is a potent, selective, and orally available antagonist of the bradykinin B2 receptor. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant has the potential to treat the manifestations of an HAE attack and to prevent the occurrence of attacks. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration; a capsule to enable rapid onset of activity for acute treatment, and an extended-release tablet to enable sustained absorption and efficacy in prophylactic treatment.

About Pharvaris

Building on its deep-seated roots in HAE, Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE efficacious, safe, and easy-to-administer alternatives to treat attacks, both on-demand and prophylactically. The company brings together the best talent in the industry with deep expertise in rare diseases and HAE. For more information, visit https://pharvaris.com/.

Forward-Looking Statements

This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words believe, anticipate, expect, estimate, may, could, should, would, will, intend and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules (PHVS416) and deucrictibant extended-release tablets (PHVS719), which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1 and CHAPTER-1 Phase 2 studies in ongoing and future nonclinical studies and clinical trials; risks arising from epidemic diseases, such as the COVID-19 pandemic, which may adversely impact our business, nonclinical studies, and clinical trials; the outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws, our ability to successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and the current conflict between Russia and Ukraine and the Hamas attack against Israel and the ensuing war; and the other factors described under the headings Cautionary Statement Regarding Forward-Looking Statements and Item 3. Key Information”D. Risk Factors in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release.

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How to Get Your Earnest Money Back in Real Estate

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Bloomberg Media getting into the education business

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Bloomberg Media is partnering with education provider Emeritus to launch Bloomberg Learning, a suite of online courses, reports Ray Schultz of Publishers Daily.

Schultz reports, “The programming, featuring content from domain experts, will be four to six hours a week for six weeks. Participants will also receive a subscription to Bloomberg.com during their enrollment.

“The first AI program, AI Strategy: Driving Impact for Business, will launch this summer.

“Bloomberg cites statistics showing that 80% of global professionals believe skill enhancement is key to career success. And 53% fear that falling behind in tech skills could lead to them eventually being replaced by technology.

“‘With Emeritus’ deep expertise in course design and development, we’re excited to offer small private online courses with hands-on learning and grow a deeper relationship with new consumers,’ says Nick Sallon, chief partnerships officer at Bloomberg Media.”

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Dragonfly Energy Named Business of the Year at Nevada Business Awards By Investing.com

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RENO, Nev., May 08, 2024 (GLOBE NEWSWIRE) — Dragonfly Energy Holdings Corp. (Nasdaq: DFLI) (Dragonfly Energy or the Company), an industry leader in green energy storage and maker of Battle Born Batteries ®, received the Spirit of Nevada award at the annual Nevada Business Awards presented by Nevada Business magazine.

The Nevada Business Awards recognize Nevada businesses for their contributions to the state and honor the top companies for their resilience and longevity, those that are new, and those that demonstrate support of the community. Eight categories range from micro-enterprises to Business of the Year, and nominations in each category are made and awarded separately in Northern and Southern Nevada. Dragonfly Energy was nominated in the Spirit of Nevada/Business of the Year category.

It’s an honor to receive this award and be named among the standout Nevada businesses that have come before us, Dr. Denis Phares, Dragonfly Energy CEO, said. We founded Dragonfly Energy in Nevada for many practical reasons, but also because we saw a welcoming and supportive business community here that has been essential to our success and growth. We look forward to the ongoing collaboration with Nevada leaders and businesses and to continuing to foster the growth of the lithium economy in Nevada and the U.S.

Dragonfly Energy is an industry leader in lithium-ion battery technology with an increasingly strong market presence in numerous industries. Currently designing and assembling lithium batteries at their Reno facility, the Company plans to manufacture lithium battery cells domestically using a patented and environmentally friendly process, helping to reduce America’s reliance on foreign supply chains and supporting the circular lithium economy in Nevada.

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About Dragonfly EnergyDragonfly Energy Holdings Corp. (Nasdaq: DFLI) is a comprehensive lithium battery technology company, specializing in cell manufacturing, battery pack assembly, and full system integration. Through its renowned Battle Born Batteries ® brand, Dragonfly Energy has established itself as a frontrunner in the lithium battery industry, with hundreds of thousands of reliable battery packs deployed in the field through top-tier OEMs and a diverse retail customer base. At the forefront of domestic lithium battery cell production, Dragonfly Energy’s patented dry electrode manufacturing process can deliver chemistry-agnostic power solutions for a broad spectrum of applications, including energy storage systems, electric vehicles, and consumer electronics. The Company’s overarching mission is the future deployment of its proprietary, nonflammable, all-solid-state battery cells.

To learn more about Dragonfly Energy and its commitment to clean energy advancements, visit www.dragonflyenergy.com/investors.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief, or expectations, including, but not limited to, statements regarding the Nevada Business Awards, the Company’s future results of operations and financial position, planned products and services, business strategy and plans, market size and growth opportunities, competitive position and technological and market trends. Some of these forward-looking statements can be identified by the use of forward-looking words, including may, should, expect, intend, will, estimate, anticipate, believe, predict, plan, targets, projects, could, would, continue, forecast or the negatives of these terms or variations of them or similar expressions.

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These forward-looking statements are subject to risks, uncertainties, and other factors (some of which are beyond the Company’s control) which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Such factors include those set forth in the sections entitled Risk Factors and Cautionary Note Regarding Forward-Looking Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and in the Company’s subsequent filings with the SEC available at  www.sec.gov. If any of these risks materialize or any of the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company presently does not know or that it currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. All forward-looking statements contained in this press release speak only as of the date they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Caldwell BaileyICR, Inc.DragonflyIR@icrinc.com

Media RelationsAmy Demuth, RAD Strategies Inc.dragonfly@radstrategiesinc.com

Source: Dragonfly Energy Holdings Corp.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/48f2d2d3-1cad-4c07-aaaa-629c75d24ad4

NV Business Awards – Dragonfly Energy

“The Dragonfly Energy Team Accepts Business of the Year Award”



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Aptevo Therapeutics Reports 1Q 2024 Financial Results and Provides a Business Update By Investing.com

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Heavily pre-treated breast cancer patient who achieved stable disease on study, remains on treatment for more than eleven months after entering the ALG.APV-527 Phase 1 trial with progressive disease and transitioning to higher dose with potential for greater clinical benefit, experienced no new adverse events since the transition to the higher dose level

APVO436 Phase 1b/2 dose optimization trial initiation of APVO436 for frontline AML in combination with venetoclax + azacitidine in venetoclax naïve patients expected 2Q 2024

SEATTLE, WA / ACCESSWIRE / May 8, 2024 / Aptevo Therapeutics Inc . (NASDAQ:), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today reported financial results for the quarter ended March 31, 2024 and provided a business update.

  • A heavily pretreated breast cancer patient, enrolled in the ALG.APV-527 Phase 1 open-label, multi-center, multi-cohort trial for the treatment of multiple solid tumor types, entered the trial with progressive disease and improved to long-lasting stable disease (SD) while on therapy. The patient has remained on study for more than eleven months, having been successfully transitioned to a higher dose level and has experienced no new adverse events since the transition. The higher dose may allow for increased clinical benefit. The trial is more than 50% enrolled and we are dosing cohort 5. Additional information about the Company’s ALG.APV-527 clinical program appears below.
  • The Company is on track to initiate its upcoming dose optimization trial in 2Q 2024to further evaluate APVO436 for the treatment of frontline acute myeloid leukemia (AML). Aptevo has partnered with premier CRO, Prometrika, for the upcoming study. The first part of the Phase 1b/2 study is a dose optimization trial evaluating standard of care venetoclax + azacitidine along with APVO436 as a frontline treatment for AML patients. It is planned as an open-label, multi-center, multi-cohort study. The trial will evaluate safety/tolerability and efficacy of the triplet combination at multiple dose levels. Additional information about the Company’s APVO436 clinical program appears below.

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“Aptevo has had an exciting first quarter, making progress in both clinical programs. We are particularly enthusiastic about one breast cancer patient in our ALG.APV-527 trial who has remained on study with stable disease for more than eleven months, in addition, to being safely and successfully transitioned to a higher dose level within the study. This rarely happens in an early-stage trial, and we believe it underscores the potential of our bispecific solid tumor candidate,” said Marvin White, President & CEO of Aptevo. “Additionally, we plan to initiate our APVO436 dose optimization trial in frontline AML patients this quarter. Overall, we are excitingly seeing in the clinic that our molecules are performing as they were engineered to perform.”

2024 Q1 Summary Financial Results
Cash Position: Aptevo had cash and cash equivalents as of March 31, 2024, totaling $10.3 million. On a proforma basis, cash, and cash equivalents as of March 31, 2024, total $14.3 million, including the proceeds from the equity raise closed on April 10, 2024.

Research and Development Expenses: Research and development expenses decreased by $0.4 million, from $4.2 million for the three months ended March 31, 2023, to $3.8 million for the three months ended March 31, 2024. The decrease was primarily due to lower spending on APVO436 clinical trial as we concluded the Phase 1b study and are preparing to initiate the frontline AML dose optimization study and lower spending on preclinical projects and employee costs. The decrease was partially offset by higher spending on ALG.APV-527 Phase 1 clinical trial costs.

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General and Administrative Expenses: General and administrative expenses decreased by $0.4 million, from $3.6 million for the three months ended March 31, 2023, to $3.2 million for the three months ended March 31, 2024. The decrease is primarily due to lower employee and consulting costs.

Other Income (Expense), Net:
Other Income (Expense) from Continuing Operations, Net consists of other income, net of $0.2 million and other expense, net of $0.1 million for the three months ended March 31, 2024, and 2023, respectively. The change in other income (expense), net is primarily due to the repayment of our MidCap term loan in the first quarter of 2023.

Gain Related to Sale of Non-Financial Asset consists of a $9.7 million gain recorded in Q1 2023 related to the sale of all of the deferred payments and a portion of the milestone payments from Medexus to XOMA. We did not record such income in the first quarter of 2024.

Discontinued Operations: We did not record income from discontinued operations for the three months ended March 31, 2024. For the three months ended March 31, 2023, we recorded $0.9 million of contingent gain consideration from previous discontinued operations.

Net Income (Loss): Aptevo had a net loss of $6.8 million or $9.95 per share for the three months ended March 31, 2024, compared to a net income of $2.8 million or $17.38 per share for the corresponding period in 2023.

Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts, unaudited)

March 31, 2024 December 31, 2023

ASSETS

Current assets:

Cash and cash equivalents

$ 10,250 $ 16,904

Prepaid expenses

1,133 1,473

Other current assets

691 689

Total current assets

12,074 19,066

Property and equipment, net

789 895

Operating lease right-of-use asset

4,766 4,881

Total assets

$ 17,629 $ 24,842

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and other accrued liabilities

$ 3,720 $ 3,984

Accrued compensation

1,610 2,098

Other current liabilities

968 1,142

Total current liabilities

6,298 7,224

Other long-term liabilities

14

Operating lease liability

5,214 5,397

Total liabilities

11,526 12,621

Stockholders’ equity:

Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero shares
issued or outstanding

Common stock: $0.001 par value; 500,000,000 shares authorized; 673,430 and
442,458 shares issued and outstanding at March 31, 2024 and
December 31, 2023, respectively

66 61

Additional paid-in capital

236,318 235,607

Accumulated deficit

(230,281 ) (223,447 )

Total stockholders’ equity

6,103 12,221

Total liabilities and stockholders’ equity

$ 17,629 $ 24,842

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Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts, unaudited)

For the Three Months Ended
March 31,
2024 2023

Operating expenses:

Research and development

$ (3,752 ) $ (4,168 )

General and administrative

(3,231 ) (3,588 )

Loss from operations

(6,983 ) (7,756 )

Other income (expense):

Other income (expense) from continuing operations, net

149 (67 )

Gain related to sale of non-financial asset

9,650

Net (loss) income from continuing operations

$ (6,834 ) $ 1,827

Discontinued operations:

Income from discontinued operations

$ $ 946

Net (loss) income

$ (6,834 ) $ 2,773

Basic and diluted net (loss) income per share from continuing operations:

Basic

$ (9.95 ) $ 11.45

Diluted

$ (9.95 ) $ 11.45

Basic and diluted net (loss) income per share:

Basic

$ (9.95 ) $ 17.38

Diluted

$ (9.95 ) $ 17.38

Shares used in calculation:

Basic

686,735 159,597

Diluted

686,735 159,597

About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immuno-oncology therapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes for cancer patients. For more information, please visit www.aptevotherapeutics.com.

ALG.APV-527
ALG.APV-527 is a conditional 4-1BB agonist bispecific that is designed for activation only upon simultaneous binding to 4-1BB and 5T4. It is designed to target cancer cells by activating both T cells and natural killer cells and is intended to bind to tumor-specific antigens while sparing healthy cells and maximizing immune response. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. The compound is currently being evaluated for multiple solid tumor types in a multi-center, dose escalation trial that is more than 50% enrolled.

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Additional promising preliminary data includes:

  • In addition to the patient described above, a second heavily pretreated breast cancer patient who was progressing prior to enrolling in the trial has sustained long lasting stable disease and remained on study drug for seven months. Analysis demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active
  • Treatment to date has been overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing and the Company is dosing cohort five (of six)
  • ALG.APV-527 has been measurable in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose
  • Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527

APVO436
Aptevo’s wholly owned lead proprietary drug candidate, APVO436 is targeting AML and is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. APVO436 is purposefully designed to reduce the likelihood and severity of CRS by use of a unique CD3 derived from CRIS-7 vs. the CD3 used by other competitors. APVO436 has received orphan drug designation (“orphan status”) for AML according to the Orphan Drug Act.

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The Phase 1b dose escalation trial results showed a 91% clinical benefit rate in combination with venetoclax + azacitidine in venetoclax naïve patients, a 27% incidence of CRS across all trial cohorts (the majority were grades 1 & 2) and meaningful duration of remission, including three patients who transitioned to transplant after receiving therapy, the best possible outcome for AML patients.

The Company is planning to initiate the first part of the Phase 1b/2 dose optimization program in this quarter.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo’s expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo’s clinical programs, including statements related to anticipated clinical and regulatory milestones such as Phase 1b/2 trial initiation for APVO436 in frontline, venetoclax naïve AML patients, whether further study of APVO436 in a Phase 1b dose optimization trial focusing on multiple doses of APVO436 in combination with venetoclax + azacitidine on a targeted patient population will continue to show clinical benefit, whether Aptevo’s final trial results will vary from its earlier assessment, whether further study of ALG.APV-527 across a cross section of multiple tumor types will continue to show clinical benefit, whether higher dose ranges for ALG.APV-527 will result in increased signs of clinical activity, whether biomarker analyses will continue to confirm biological activity of ALG.APV-527, the possibility and timing of interim data readouts for ALG.APV-527, whether Aptevo’s final trial results will vary from its preliminary or interim assessments, the possibility and timing of preliminary or interim data readouts for ALG.APV-527, statements related to the progress of and enthusiasm for Aptevo’s clinical programs, statements related to Aptevo’s cash position and balance sheet, statements related to Aptevo’s ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words “may,” “continue to,” “believes,” “knows,” “expects,” “optimism,” “potential,” “designed,” “promising,” “plans,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.

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There are several important factors that could cause Aptevo’s actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo’s business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of APVO436, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo’s product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the rising conflict in the Middle East, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, continued market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo’s expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.

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CONTACT:
Miriam Weber Miller
Head, Investor Relations & Corporate Communications
Aptevo Therapeutics
Email: IR@apvo.com or Millerm@apvo.com
Phone: 206-859-6628

SOURCE: Aptevo Therapeutics



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