Short interest for Katapult Holdings gives investors a sense of the degree to which investors are betting on the decline of Katapult Holdings's stock. Short interest data is updated every two weeks.

Katapult Holdings Stock (NASDAQ:KPLT), Short Interest Report

Katapult Holdings

Katapult Holdings Inc is a technology driven lease-to-own platform that integrates with omni-channel retailers and e-commerce platforms to power the purchase of everyday durable goods for underserved U.S. non-prime consumers. It is an E-Commerce focused FinTech company offering an innovative lease-purchase solution to consumers and enabling essential transactions at the merchant point of sale. Katapult is associated with hundreds of retailers across the United States.

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Shares of  Limbach Holdings, Inc. (NASDAQ: LMB) fell sharply during Thursday’s session after the company reported fourth-quarter financial results and issued FY24 revenue guidance below estimates.

Why Limbach Holdings Shares Are Trading Lower By Around 15%? Here Are Other Stocks Moving In Thursday&#39;s Mid-Day Session

Short Ideas

Pre-Market Outlook

As of Feb. 14, 2024, five stocks in the financial sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions.

Top 5 Financial Stocks That May Crash In Q1

Long Ideas

ATLC

BLFY

The most oversold stocks in the financial sector presents an opportunity to buy into undervalued companies.

Top 4 Financial Stocks That May Explode This Quarter

Katapult Holdings Inc

Guidance

FIVN

Five9 Continues To Expect FY24 Revenue Of $1.053B-$1.057B (Est $1.055B), Raises Adj EPS Outlook From $2.14-$2.18 To $2.15-$2.19 (Est $2.16)

Outlook
The Company is updating its full year 2024 guidance ranges as follows ($ millions, unless otherwise noted):
<figure class="table"> 
<table>
<tbody>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">Previous</td>
<td colspan="1" rowspan="1">Updated&#x2A;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Revenue</td>
<td colspan="1" rowspan="1">$600 - $700</td>
<td colspan="1" rowspan="1">$567 - $667</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Non-GAAP Gross Margin (%)</td>
<td colspan="1" rowspan="1">15% - 20%</td>
<td colspan="1" rowspan="1">Unchanged</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Adjusted EBITDA</td>
<td colspan="1" rowspan="1">$5 - $20</td>
<td colspan="1" rowspan="1">Unchanged</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Bookings</td>
<td colspan="1" rowspan="1">$1,500 - $2,000</td>
<td colspan="1" rowspan="1">Unchanged</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">CARR (year-end)</td>
<td colspan="1" rowspan="1">$115 - $130</td>
<td colspan="1" rowspan="1">Unchanged</td>
</tr>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">&nbsp;</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Operating Cash Flow</td>
<td colspan="1" rowspan="1">Greater than $50</td>
<td colspan="1" rowspan="1">Unchanged</td>
</tr>
</tbody>
</table>
</figure>
See the section below titled "Reconciliations of Non-GAAP Financial Measures" for information regarding why Stem is unable to reconcile Non-GAAP Gross Margin and Adjusted EBITDA guidance to their most comparable financial measures calculated in accordance with GAAP.
&#x2A;Full year revenue guidance has been adjusted downward dollar-for-dollar solely as a result of the $33 million reduction in revenue.
The Company reaffirms full year 2024 revenue projected quarterly performance as follows:
<figure class="table"> 
<table>
<tbody>
<tr>
<td colspan="1" rowspan="1">&nbsp;</td>
<td colspan="1" rowspan="1">1QA</td>
<td colspan="1" rowspan="1">2QE</td>
<td colspan="1" rowspan="1">3QE</td>
<td colspan="1" rowspan="1">4QE</td>
</tr>
<tr>
<td colspan="1" rowspan="1">Revenue</td>
<td colspan="1" rowspan="1">$25M</td>
<td colspan="1" rowspan="1">10%</td>
<td colspan="1" rowspan="1">32%</td>
<td colspan="1" rowspan="1">54%</td>
</tr>
</tbody>
</table>
</figure>
 &nbsp;

STEM

Stem Lowers FY24 Revenue Guidance From $600M-$700M To $567M-$667M Vs $672.29M Est.

MercadoLibre (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MELI#NASDAQ">MELI</a>) reported quarterly earnings of $6.78 per share which beat the analyst consensus estimate of $6.14 by 10.42 percent. The company reported quarterly sales of $4.333 billion which beat the analyst consensus estimate of $3.850 billion by 12.56 percent. This is a 42.67 percent increase over sales of $3.037 billion the same period last year.

Earnings

Earnings Beats

MELI

MercadoLibre Q1 2024 GAAP EPS $6.78 Beats $6.14 Estimate, Sales $4.333B Beat $3.850B Estimate

Booking Holdings Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BKNG#NASDAQ">BKNG</a>)&nbsp;reported its first-quarter financial results after the bell on Thursday. Here are the key&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/05/n38552522/booking-holdings-to-make-first-quarter-2024-earnings-press-release-available-on-companys-investor-" rel="noreferrer noopener">figures from the report</a>.
Booking reported quarterly earnings of $20.39 per share, which beat the analyst consensus estimate of $14.06 by 45.02%.&nbsp;
The company reported quarterly sales of $4.415 billion, which beat the analyst consensus estimate of $4.254 billion. This represents a 16.86 percent increase over sales of $3.778 billion from the same period last year.&nbsp;
Booking said gross travel bookings of all travel services booked by customers, net of cancellations, were $43.5 billion, an increase of 10% from the prior-year quarter. Room nights&nbsp;booked&nbsp;increased by 9% from the same period last year.&nbsp;
The board of directors declared a cash dividend of $8.75 per share, payable on June 28 to stockholders of record as of the close of business on June 7.
"We are pleased to report a strong start to 2024 with first quarter year-over-year growth in room nights of 9%, revenue of 17%, and operating income of 76%, all of which were ahead of our prior expectations," said&nbsp;Glenn Fogel, CEO of Booking Holdings. "As we continue our work to deliver a better planning, booking, and traveling experience for our travelers, we are seeing encouraging results at Booking.com with increasing direct mix, higher frequency, and more of our travelers moving into the upper Genius loyalty tiers."
Related News:&nbsp;<a target="_blank" href="https://www.benzinga.com/news/24/05/38595976/rivian-automotive-receives-827m-incentive-package-whats-going-on-with-rivian-stock" rel="noreferrer noopener">Rivian Automotive Receives $827M Incentive Package: What's Going On With Rivian Stock?</a>
BKNG Price Action:&nbsp;According to&nbsp;<a target="_blank" href="https://pro.benzinga.com/?gspk=YWRhbWVja2VydDUzMzY&amp;gsxid=zBMR4PKmcgBw" rel="noreferrer noopener">Benzinga Pro</a>, BKNG shares closed higher by 1.68% at $3,472.91&nbsp;at the time of publication Thursday.
Image: Courtesy of Booking Holdings, Inc.

BKNG

Booking.Com's Q1 Earnings Show Growth In Travel Demand - Here's Why

Great Elm Capital (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GECC#NASDAQ">GECC</a>) reported quarterly earnings of $0.37 per share which missed the analyst consensus estimate of $0.41 by 9.76 percent. The company reported quarterly sales of $8.909 million which missed the analyst consensus estimate of $9.136 million by 2.48 percent. This is a 5.93 percent increase over sales of $8.410 million the same period last year.

Earnings Misses

GECC

Great Elm Capital Q1 2024 GAAP EPS $0.37 Misses $0.41 Estimate, Sales $8.909M Miss $9.136M Estimate

WIIM

HOLX

Hologic shares are trading higher after the company reported better-than-expected Q2 earnings and narrowed its guidance.

Palomar Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PLMR#NASDAQ">PLMR</a>) reported quarterly earnings of $1.09 per share which beat the analyst consensus estimate of $0.94 by 15.96 percent. This is a 36.25 percent increase over earnings of $0.80 per share from the same period last year. The company reported $107.866 million in sales this quarter. This is a 29.58 percent increase over sales of $83.241 million the same period last year.

PLMR

Palomar Hldgs Q1 2024 Adj EPS $1.09 Beats $0.94 Estimate, Sales $107.866M Up From $83.241M YoY

EXPE

Expedia Group shares are trading lower after the company lowered its full-year guidance.

Stem (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/STEM#NYSE">STEM</a>) reported quarterly losses of $(0.46) per share which missed the analyst consensus estimate of $(0.21) by 119.05 percent. This is a 58.62 percent decrease over losses of $(0.29) per share from the same period last year. The company reported quarterly sales of $25.47 million which missed the analyst consensus estimate of $57.11 million by 55.40 percent. This is a 62.21 percent decrease over sales of $67.41 million the same period last year.

Stem Q1 EPS $(0.46) Misses $(0.21) Estimate, Sales $25.47M Miss $57.11M Estimate

Five9 Expects Q2 Revenue Of $244M-$245M (Est $248.02M), Adj EPS Of $0.42-$0.44 (Est $0.44)

CLFD

Clearfield shares are trading higher after the company reported better-than-expected Q2 results and increased its repurchase authorization.

Buybacks

Board Of Directors Increased Share Repurchase Program Authorization From $40M To $65M

At the recent Benzinga Cannabis Capital Conference, Jonathan Black, CEO of Cheech and Chong&#8217;s Global Holdings, highlighted the transformation in <a href="https://www.benzinga.com/markets/cannabis/24/03/37595637/exclusive-tommy-chong-on-cheech-and-chongs-sxsw-premiere-cannabis-legalization-the-perils-of-inf">cannabis retail experiences</a>. Black shared insights during a side interview before his panel discussion, emphasizing the importance of learning from each event. 
&#8220;I always look for something to learn,&#8221; he said, praising the diverse perspectives that Benzinga events bring together.
Cheech and Chong&#8217;s dispensaries are recognized for creating more than just transactions; they aim to craft memorable experiences. While Black credits his team for their efforts, he noted the detailed attention to the ambiance of their stores. 
&#8220;We have designed the look and feel to resonate with the legacy of 52 years,&#8221; Black explained. This includes everything from store design to minor details like themed wallpaper, all contributing to an engaging and welcoming atmosphere that echoes the iconic duo&#8217;s filmography.
<h3 class="wp-block-heading">Strategic Partnerships And Community Impact</h3>
Another focus of the conversation was the partnership with Dreams Dispensary in New Mexico, which has bolstered the company&#8217;s community presence.
Black values personal relationships and operational knowledge when choosing partners, highlighting the synergy between Cheech and Chong&#8217;s and Dreams Dispensary&#8217;s values and experiences. This collaboration boosts market competition and supports community engagement through job creation and social interactions.
Looking towards the future, Black discussed the long-term goals for their locations in New Mexico, emphasizing community and connectivity. 
The dispensaries leverage a social media platform created by the company to foster community interaction, which plays a crucial role in their strategy to enhance customer loyalty and local engagement.
<figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"> 
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<iframe loading="lazy" title="Jonathan Black &#x7C; Cheech and Chong" width="500" height="281" src="https://www.youtube.com/embed/tGwHDD228AM?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
</div>
</figure>
<hr class="wp-block-separator has-alpha-channel-opacity" />
Cannabis rescheduling seems to be right around the corner. Want to understand what this means for the future of the industry? Hear directly for top executives, investors, and policymakers at the 19th Benzinga Cannabis Capital Conference, coming to Chicago this Oct. 8-9. <a href="https://www.eventbrite.com/e/benzinga-capital-conference-cannabis-fall-2024-tickets-858948065787?aff=oddtdtcreator" target="_blank" rel="noreferrer noopener">Get your tickets now</a> before prices surge by following <a href="https://www.eventbrite.com/e/benzinga-capital-conference-cannabis-fall-2024-tickets-858948065787?aff=oddtdtcreator" target="_blank" rel="noreferrer noopener">this link</a>.
Now Read: <a href="https://www.benzinga.com/markets/cannabis/24/05/38597432/new-tax-rules-in-cannabis-what-are-the-consequences-dea-rescheduling">New Tax Rules In Cannabis: What Are The Consequences DEA Rescheduling?</a>
Photo: s_bukley on Shutterstock

Cannabis

Events

Cheech And Chong Brand CEO Talks Cannabis Retail Expansion And Designs That 'Resonate With The Legacy Of 52 Years'

AXT (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXTI#NASDAQ">AXTI</a>) reported quarterly losses of $(0.05) per share which beat the analyst consensus estimate of $(0.09) by 44.44 percent. This is a 37.5 percent increase over losses of $(0.08) per share from the same period last year. The company reported quarterly sales of $22.688 million which beat the analyst consensus estimate of $21.564 million by 5.21 percent. This is a 16.92 percent increase over sales of $19.405 million the same period last year.

AXTI

AXT Q1 2024 GAAP EPS $(0.05) Beats $(0.09) Estimate, Sales $22.688M Beat $21.564M Estimate

QIAGEN &nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QGEN#NYSE">QGEN</a>, Frankfurt Prime Standard: QIA)))) today announced the availability of QCI Secondary Analysis, a cloud-based software-as-a-services (SaaS) solution enabling high-throughput secondary analysis for use with any clinical next-generation sequencing (NGS) data.
This turnkey service supports all QIAGEN QIAseq panels and seamlessly integrates with QCI Interpret, QIAGEN's clinical variant interpretation and reporting software, to deliver highly scalable and customizable Sample to Insight workflows for oncology and inherited disease applications.
Typically, sequencing data is processed in three phases: After the signals registered by the NGS device have initially been translated into digital information (primary analysis), the DNA fragments encoded must be merged into a connected sequence and analyzed for variants in relation to a human reference genome (secondary analysis). In the third and final step (tertiary analysis), the identified variants are interpreted in the context of a specific clinical picture.
"Our goal is to empower molecular testing labs, regardless of size, budget, and experience, to leverage the power of comprehensive genomic information to advance precision medicine in every setting," said Jonathan Sheldon, Senior Vice President of QIAGEN Digital Insights. "Due to NGS adoption barriers, including complexity and cost, a vast majority of small- to mid-size molecular laboratories rely on limited single-gene tests or choose to outsource sample testing for more comprehensive NGS analysis. However, with the launch of our new NGS secondary analysis software, we are making NGS testing more accessible to decentralized labs."
"QCI Secondary Analysis is particularly valuable for labs looking to start running NGS-based tests because it's a turnkey solution with easy-to-use features for the everyday lab technician," said Can Koşukcu, Senior Bioinformatics Application Scientist of DiagnoSeq, an early-access customer of QCI Secondary Analysis. "With the availability of this new solution, QIAGEN has simplified the whole bioinformatics pipeline, providing an integrated workflow that minimizes resource investment and maximizes productivity."
Expanding on the QIAGEN Clinical Insights (QCI) portfolio, QCI Secondary Analysis is designed to streamline analysis from a range of assay types, enabling labs to process more sequencing data without extensive time and resource investment. The turnkey solution is deployed on the QIAGEN Clinical Cloud, a secure cloud environment ensuring the highest degree of isolation and data protection, including compliance with ISO 27001, General Data Protect Regulation (GDPR), and the Health Insurance Portability and Accountability Act (HIPPA) requirements.
While QCI Secondary Analysis is a plug-in-play solution that can support any panel, NGS instrument or software, the true value of this new offering is how it complements QIAGEN's Sample to Insight portfolio. QCI Secondary Analysis is validated for use for all QIAseq panels, can be used with LightSpeed Clinical, a new software module within QIAGEN CLC Genomics Workbench Premium that enables ultra-fast NGS analysis, and directly integrates with QCI Interpret, QIAGEN's variant interpretation and reporting platform that has been trusted to analyze and interpret more than 3.5 million NGS patient test cases worldwide.
QIAGEN Digital Insights solutions are used by national precision medicine programs worldwide to process over 850,000 clinical samples per year. They enable researchers and clinicians to access advanced tools for data processing and interpretation, empowering them to make well-informed decisions that lead to improved research results. QDI offers automated workflows, scalability, and efficient turnaround times, as well as solutions tailored to fit any lab, database, API, service, or workflow application.
More information on QIAGEN's Sample to Insight solutions and the new QCI Secondary Analysis service can be found <a href="https://www.globenewswire.com/Tracker?data=0hNgv00J9zlTgslNt3N08xU7sjI63bXhslLLWIQy5xlvVLhPIsLXG_NA3jMoY0HQ_FDzfhXb9EDvNZQ-YilncXZ5uiKDP0UVFXcDnyiuODvxyG7156QN-qfkSvFpIO9-">here</a>.

Biotech

General

QGEN

QIAGEN Enhances Bioinformatics Workflows With New Secondary Analysis Solution For Oncology And Inherited Disease Applications

COHU

Cohu Expects Q2 Sales Of $105M +/- $6M, Est $108.11M

<a href="https://www.globenewswire.com/Tracker?data=arNncyU0hD4c9TTCSBMQgdSz_Ig0_KBwJKP8RlHobSHOuGG7UYBv2lHeBYKuI-ngfg3LFODt7Ue9bihrcjiQrw==">Trupanion</a>, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TRUP#NASDAQ">TRUP</a>), a leading provider of medical insurance for cats and dogs, today announced that its Board of Directors has unanimously approved the appointment of Margi Tooth to Chief Executive Officer, effective August 1, 2024. Tooth's appointment to CEO marks the culmination of a multi-year, board-led process. Tooth will also continue as President and hold the dual titles of CEO and President. Additionally, Tooth is anticipated to be appointed to Trupanion's Board of Directors during its July meeting. Trupanion's founder and outgoing CEO Darryl Rawlings will continue to serve in the role of Chair of the Board, in which capacity he will continue to oversee the Company's board of directors. &nbsp;
Tooth holds nearly two decades of experience as a growth-oriented leader within the pet insurance category. Her tenure includes over seven years with the UK's largest pet insurance provider, during which time the category saw tremendous growth, reaching approximately 25% penetration.
Tooth's appointment to CEO follows a proven career at Trupanion, spanning over a decade in leadership positions of increasing responsibility including Chief Marketing Officer, Chief Revenue Officer and as of January of 2021, President. During her time at Trupanion, Tooth has played a pivotal role in the company's growth and success, overseeing the execution of its strategic plan which includes diversifying into new channels, products, and geographies, while ensuring that the core Trupanion product, designed with the heart of the veterinary community in mind, remains front and center. Under her leadership, Trupanion has achieved significant milestones, including surpassing $1 billion in revenue, reaching over 1 million subscription pets, and paying out nearly $3 billion in veterinary invoices. Additionally, Tooth's leadership has led to improving operational efficiency through targeted overhauls in several departments.
Ms. Tooth's extensive experience, including serving as President of Trupanion since 2021, coupled with her deep understanding of the pet insurance industry, strongly positions her to lead Trupanion into its next phase of growth in its global underpenetrated markets, while staying aligned with the needs of veterinarians and pet owners.
Darryl Rawlings stated, "There is no one I trust greater than Margi to lead Trupanion as CEO. During Margi's tenure, Trupanion has experienced significant growth, with revenue increasing from less than $100 million to over $1 billion. Her impact, however, extends well beyond the numbers. In the last 18 months, Margi has assumed oversight of every department at Trupanion and started to overhaul key operational areas to drive improved efficiency and performance. Margi brings exceptional passion, dedication, and knowledge to the role and she embodies the heart and spirit of Trupanion. It has been my honor and privilege to serve as a resource to her over the past decade and I look forward to serving our shareholders as Chair of the Board."
Murray Low, Trupanion's Lead Independent Director, stated, "Today's announcement reflects our confidence in Margi's proven leadership. With this move, we enable a smooth transition to a proven executive in Margi, while maintaining ongoing board-level leadership from Darryl. The unanimous support from the Board and appointment ahead of our original timeline underscores our trust in her abilities. We're eager to see her continue Trupanion's success."
Margi Tooth stated, "It's an honor to lead Trupanion as CEO. Our mission to support pet parents is my daily motivation and it resonates deeply with me. I'm proud to lead our equally passionate team in serving our members, and the veterinary community, paying out nearly $2 million in veterinary invoices daily. Yet still, with less than 5% of pets in North America and Continental Europe covered by pet medical insurance today, there's so much more to be done to ensure pets receive the care they deserve and veterinarians can practice the medicine for which they've trained. I'm excited to lead Trupanion in this journey, and am forever grateful for the support and mentoring from Darryl, and the Board, and I look forward to our partnership moving forward."
Rawlings once again confirmed his commitment to serve as Chair of the Board until 2035, if amenable to shareholders. In addition to serving as Chair of the Board, Rawlings will enter into a consulting agreement with Trupanion to provide services related to the development of the Company's food initiative.

Management

TRUP

Trupanion's Margi Tooth Appointed Chief Executive Officer Effective August 1, 2024

AMGN

Amgen shares are trading higher after the company reported better-than-expected Q1 financial results. Also, the company announced a $50 million milestone payment from Royalty Pharma.

ASND

Ascendis Pharma Q1 Sales €95.894M Beat €79.492M Estimate

<ul>
<li>Collaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA&#xAE;, ImmunityBio's recently approved treatment for non-muscle invasive bladder cancer (NMIBC)</li>
<li>Serum Institute of India (SII) will manufacture both standard BCG ("sBCG") and next-generation recombinant BCG ("iBCG"), creating a long-term solution to chronic BCG supply shortage issues</li>
<li>Standard BCG (sBCG) from the Serum Institute is currently administered in number of countries worldwide for treatment of NMIBC</li>
<li>Recombinant BCG (iBCG) has demonstrated potent immunogenicity with CD8+ and CD4+ stimulation and improved safety compared to standard BCG in clinical trials across Europe.</li>
<li>Collaboration will help to ensure availability of BCG for all approved indications that benefit from ANKTIVA's triangle offense of natural killer cells, T cells, and memory T cells</li>
<li>Global clinical trials planned to study standard of care ANKTIVA plus BCG with globally available sBCG and iBCG from Serum Institute, the QUILT BCG randomized clinical trial</li>
</ul>
ImmunityBio, Inc. ((<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;,%20url=https%3A%2F%2Fwww.nasdaq.com%2Fmarket-activity%2Fstocks%2Fibrx&amp;,%20esheet=53971559&amp;,%20newsitemid=20240502530543&amp;,%20lan=en-US&amp;,%20anchor=NASDAQ%3A+IBRX&amp;,%20index=1&amp;,%20NASDAQ:%3Ca%20class=">IBRX</a>), has signed an exclusive global arrangement with the Serum Institute of India, the world's largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the U.S., as well as a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln) for currently approved and potential future indications, subject to regulatory approvals.
"We are pleased to partner with the Serum Institute of India so that the power of its large-scale, world-class, GMP manufacturing capacity can be used to address the issue of BCG shortage, which affects thousands of bladder cancer patients annually," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "We are especially proud to be partnering with Dr. Cyrus Poonawalla, the Institute's Chairman and founder and someone who has made such a positive impact on global health."
The arrangement will result in additional supplies of the current standard sBCG immediately for trials. At the same time, the two companies will work to accelerate the ongoing Phase 2 clinical trials of iBCG currently being conducted in Europe which has so far demonstrated safety advantageous over standard BCG as well as enhanced immunogenicity in driving both CD8+ and CD4 T cells.
The collaboration between SII and ImmunityBio comes on the heels of the FDA's approval of ANKTIVA for the treatment of non-muscle invasive bladder cancer with carcinoma in situ (CIS). Increasing the available supply of BCG is intended to address shortages for the combination therapy with ANKTIVA.
"The collaboration between Serum Institute of India and ImmunityBio will undoubtedly transform the way we approach cancer treatment. It will improve global access to BCG and at the same time—the unique therapy is the key to achieve a complete solution for bladder cancer. We are truly excited to witness the incredible impact this collaboration will have on improving patient outcomes and saving countless lives," said Mr. Adar C. Poonawalla, CEO, Serum Institute of India.
Originally used as a tuberculosis vaccine, BCG administered via intravesical instillation (delivery to the bladder via a catheter) has been the standard of care for patients with non-muscle invasive bladder cancer since 1977. BCG is a benign bacterium that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients.
BCG is one of the most widely used vaccines worldwide and has been given to more than 4 billion individuals with astonishing safety records. However, because BCG is a biologic drug that uses benign bacteria it is more complicated to make than many other types of drugs. SII is the largest manufacturer of BCG vaccine across the world, while Merck &amp; Co. based in New Jersey currently is the only manufacturer of BCG (TICE&#xAE; BCG) in the U.S.
"The scale and quality of vaccines that the Serum Institute manufacturers is unparalleled and we are honored to partner with Dr. Poonawalla and his leadership team on this important initiative," said Richard Adcock, President and CEO of ImmunityBio. "By providing another option for BCG, we believe more NMIBC patients will be able to benefit from this proven treatment as both a monotherapy and a combination therapy with ANKTIVA."
ImmunityBio plans to conduct clinical trials to study recombinant BCG (iBCG) and sBCG manufactured by Serum Institute in combination with ANKTIVA for the treatment of different types of bladder and other cancers. Supply of BCG is expected to be available once the protocol for the trial has been authorized by the FDA. ImmunityBio plans to submit the protocol to the FDA and to global regulatory bodies in the next 30 days.
"The opportunity to initiate a trial of an immunogenic recombinant BCG, which has already demonstrated enhanced safety compared to standard BCG in Phase 1/2 studies, is exciting. We look forward to exploring ANKTIVA in combination with BCG in non-muscle invasive bladder cancer (NMIBC) and across other tumor types. With our ability to overcome immune evasion of the tumor to BCG when BCG is given alone, and by converting a MHC- negative cold tumor to a MHC+ positive hot tumor with the combination of ANKTIVA with BCG, we will now further expand the development of our therapeutic cancer vaccine with BCG," said Dr. Soon-Shiong.
For investigators interested in participating in clinical trials or to learn more information, please email <a href="mailto:QuiltBCG@ImmunityBio.com">QuiltBCG@ImmunityBio.com</a>

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ImmunityBio, Serum Institute Of India Agree On An Exclusive Arrangement For Global Supply Of Bacillus Calmette-Guerin Across All Cancer Types

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