VBI Vaccines Stock (NASDAQ:VBIV), Trade Ideas

VBI Vaccines

VBI Vaccines Inc is a commercial-stage, the biopharmaceutical company which is engaged in developing next-generation vaccines to address unmet needs in infectious disease and immuno-oncology. The company manufactures Sci-B-Vac product which is a hepatitis B (HBV) vaccine for adults, children, and newborns. Its products include Virus-Like Particle which is vaccine platform which allows for the design of enveloped virus-like particle vaccines that closely mimic the target viruses. The company operates through the single segment being Developing vaccines to address unmet needs in infectious disease and immuno-oncology.

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Shares of  Fastenal Company (NASDAQ: FAST) fell sharply during Thursday’s session following worse-than-expected first-quarter financial results.

Why Fastenal Shares Are Trading Lower By Around 7%? Here Are Other Stocks Moving In Thursday&#39;s Mid-Day Session

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Shares of  Biophytis S.A.  (NASDAQ: BPTS) rose sharply in today’s pre-market trading after reporting FY23 results.

Why Biophytis Shares Are Trading Higher By Around 55%; Here Are 20 Stocks Moving Premarket

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Shares of  Sony Group Corporation (NYSE: SONY) fell during Wednesday’s session after the company reported third-quarter financial results and revised guidance above estimates and shared plans to list its financial arm in October 2025.

Why Sony Shares Are Trading Lower By Around 6%? Here Are Other Stocks Moving In Wednesday&#39;s Mid-Day Session

VBI Vaccines Inc

Shares of Fastenal Company (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fast#NASDAQ">FAST</a>) fell sharply during Thursday&rsquo;s session following worse-than-expected first-quarter financial results.
Fastenal reported first-quarter FY24 sales growth of 1.9% Y/Y to $1.895 billion, missing the consensus of $1.914 billion. The company&#39;s first-quarter EPS was 52 cents, missing the consensus of 53 cents.
Fastenal shares dipped 6.7% to $69.73 on Thursday.
Here are some other stocks moving in today&#39;s mid-day session.
<h3>Gainers</h3>
<ul>
<li>Rallybio Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rlyb#NASDAQ">RLYB</a>) shares climbed 89.6% to $3.09 after the company announced a collaboration with Johnson &amp; Johnson to advance therapeutics for pregnant individuals at risk of FNAIT.</li>
<li>Rent the Runway, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rent#NASDAQ">RENT</a>) shares jumped 74.5% to $12.91 after the company reported mixed fourth-quarter financial results and issued guidance.</li>
<li>Eliem Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/elym#NASDAQ">ELYM</a>) jumped 59.6% to $4.2650. The company announced that it entered into a definitive acquisition agreement to acquire Tenet and it also entered into a securities purchase agreement for a $120 million private placement.</li>
<li>Akanda Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akan#NASDAQ">AKAN</a>) gained 36% to $0.1632. Akanda, last month, announced a plan to evaluate opportunities in Bitcoin, Blockchain and AI applications in the cannabis industry.</li>
<li>Alpine Immune Sciences, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alpn#NASDAQ">ALPN</a>) rose 36.6% to $64.25 after Vertex entered into an agreement to acquire the company.</li>
<li>Candel Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cadl#NASDAQ">CADL</a>) surged 29.6% to $6.61 after the company received FDA orphan drug designation for CAN-2409 for the treatment of pancreatic cancer.</li>
<li>Enliven Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/elvn#NASDAQ">ELVN</a>) gained 26% to $24.97. Enliven Therapeutics announced proof of concept data from Phase 1 clinical trial of ELVN-001 in chronic myeloid leukemia.</li>
<li>Selina Hospitality PLC (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/slna#NASDAQ">SLNA</a>) rose 21.1% to $0.0923.</li>
<li>Globavend Holdings Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gvh#NASDAQ">GVH</a>) climbed 16.8% to $1.68.</li>
<li>Janux Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/janx#NASDAQ">JANX</a>) gained 16.8% to $52.15 following Wednesday reports suggesting the company is said to weigh a possible sale.</li>
<li>SciSparc Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sprc#NASDAQ">SPRC</a>) shares rose 15.3% to $1.9357.</li>
<li>Gyre Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gyre#NASDAQ">GYRE</a>) gained 14.6% to $15.91.</li>
<li>AnaptysBio, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/anab#NASDAQ">ANAB</a>) climbed 11.4% to $24.72. Wells Fargo analyst Derek Archila initiated coverage on AnaptysBio with an Overweight rating and announced a price target of $56.</li>
<li>Verb Technology Company, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/verb#NASDAQ">VERB</a>) gained 10.4% to $0.2010 after gaining 4% on Wednesday.</li>
<li>GigaCloud Technology Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gct#NASDAQ">GCT</a>) rose 10.2% to $34.18.</li>
<li>Nurix Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nrix#NASDAQ">NRIX</a>) gained 9.6% to $17.21. Baird analyst Joel Beatty maintained Nurix Therapeutics with an Outperform and raised the price target from $24 to $25.</li>
<li>StepStone Group LP (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/step#NASDAQ">STEP</a>) rose 7.1% to $37.46 after JP Morgan upgraded the stock from Neutral to Overweight.</li>
</ul>
<h3>Losers</h3>
<ul>
<li>Aptevo Therapeutics Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/apvo#NASDAQ">APVO</a>) shares fell 58% to $1.01 after the company priced its $4.6 million public offering.</li>
<li>Enlivex Therapeutics Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/enlv#NASDAQ">ENLV</a>) fell 54.5% to $1.81. The company announced topline results of its Phase II trial evaluating Allocetra in sepsis.</li>
<li>AVITA Medical, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rcel#NASDAQ">RCEL</a>) fell 28.6% to $10.31 after the company announced an update to its expected commercial revenue for the first quarter of 2024. BTIG downgraded the stock from Buy to Neutral.</li>
<li>Aesthetic Medical International Holdings Group Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aih#NASDAQ">AIH</a>) fell 19% to $0.3723.</li>
<li>Globe Life Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gl#NYSE">GL</a>) fell 14.6% to $89.65.</li>
<li>The Lovesac Company (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/love#NASDAQ">LOVE</a>) shares fell 14.3% to $20.00 after the company reported worse-than-expected fourth-quarter results and issued first-quarter guidance.</li>
<li>Globe Life Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gl#NYSE">GL</a>) fell 13.7% to $90.56.</li>
<li>Meiwu Technology Company Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/wnw#NASDAQ">WNW</a>) shares declined 12.4% to $1.1601 after jumping around 32% on Wednesday.</li>
<li>Acorda Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/acor#NASDAQ">ACOR</a>) fell 12% to $0.7660 after declining 14% on Wednesday. Acorda Therapeutics recently commenced voluntary proceedings under Chapter 11 of the United States Bankruptcy Code.</li>
<li>CarMax, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/kmx#NYSE">KMX</a>) fell 11.7% to $70.02 after the company reported lower-than-expected fourth-quarter earnings.</li>
<li>VBI Vaccines Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vbiv#NASDAQ">VBIV</a>) dipped 11.3% to $0.5641.</li>
<li>Nikola Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nkla#NASDAQ">NKLA</a>) fell 11.3% to $0.8680. On April 9, Wolfe Research analyst Scott Group initiated coverage on Nikola with a Peer Perform rating.</li>
<li>Marin Software Incorporated (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrin#NASDAQ">MRIN</a>) declined 10.8% to $0.5798.</li>
<li>SolarBank Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/suun#NASDAQ">SUUN</a>) fell 9.3% to $5.29. SolarBank closed purchase of 3.15 MW solar project in New York from Storke Renewable.</li>
<li>Esperion Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/espr#NASDAQ">ESPR</a>) fell 9.1% to $2.29.</li>
<li>9F Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/jfu#NASDAQ">JFU</a>) fell 8.8% to $2.7046.</li>
<li>iCoreConnect Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/icct#NASDAQ">ICCT</a>) shares fell 8.5% to $1.55 after jumping over 50% on Wednesday.</li>
<li>ClearOne, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/clro#NASDAQ">CLRO</a>) declined 8.3% to $1.00. The company recently reported fourth-quarter financial results.</li>
<li>Nyxoah S.A. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nyxh#NASDAQ">NYXH</a>) fell 7.3% to $9.83</li>
<li>Acorda Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/acor#NASDAQ">ACOR</a>) fell 6.2% to $0.8164.</li>
<li>Walker &amp; Dunlop, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/wd#NYSE">WD</a>) fell 5.3% to $87.71 after Wedbush downgraded the stock from Outperform to Neutral and lowered its price target from $130 to $95.</li>
</ul>
&nbsp;
Now Read This: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/04/38200890/top-3-health-care-stocks-which-could-rescue-your-portfolio-this-quarter"> Top 3 Health Care Stocks Which Could Rescue Your Portfolio This Quarter</a>

Why Fastenal Shares Are Trading Lower By Around 7%? Here Are Other Stocks Moving In Thursday's Mid-Day Session

WIIM

VBI Vaccines shares are trading lower after the company announced a $2 million registered direct offering at $0.88 per share.

Offerings

VBI Vaccines Announces $2M Registered Direct Offering At $0.88/Share

Shares of Biophytis S.A. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bpts#NASDAQ">BPTS</a>) rose sharply in today&rsquo;s pre-market trading after <a href="https://www.benzinga.com/quote/BPTS/earnings">reporting FY23 results</a>.
Biophytis posted a FY23 loss of &euro;0.03 per share, versus a year-ago loss of &euro;0.14 per share, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>.
Biophytis shares jumped 55.2% to $0.4920 in pre-market trading.
Here are some other stocks moving in pre-market trading.
<h3>Gainers</h3>
<ul>
<li>MyMD Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mymd#NASDAQ">MYMD</a>) shares rose 40% to $3.64 in pre-market trading after jumping 22% on Monday.</li>
<li>MediaCo Holding Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mdia#NASDAQ">MDIA</a>) shares rose 20.2% to $3.63 in pre-market trading after falling 22% on Monday. On April 4, an SEC filing showed Standard General L.P. reported a 95.2% stake in the company, as of April 1.</li>
<li>Destiny Tech100 Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dxyz#NASDAQ">DXYZ</a>) gained 18.5% to $118.33 in pre-market trading after jumping over 68% on Monday.</li>
<li>Addex Therapeutics Ltd (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/adxn#NASDAQ">ADXN</a>) shares gained 17.2% to $25.60 in pre-market trading after jumping around 21% on Monday. Addex Therapeutics and funds affiliated with Perceptive Advisors, last week, announced the launch of Neurosterix.</li>
<li>Anghami Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/angh#NASDAQ">ANGH</a>) gained 16.1% to $1.30 in pre-market trading after dipping over 3% on Monday.</li>
<li>Brainstorm Cell Therapeutics Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bcli#NASDAQ">BCLI</a>) climbed 15% to $0.8395 in pre-market trading after jumping around 12% on Monday. The company, last week, reported FY23 financial results.</li>
<li>Soligenix, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sngx#NASDAQ">SNGX</a>) shares gained 12.5% to $0.54 in pre-market trading after adding around 3% on Monday.</li>
<li>TuanChe Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tc#NASDAQ">TC</a>) rose 10.8% to $2.16 in pre-market trading.</li>
<li>Halozyme Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/halo#NASDAQ">HALO</a>) gained 10.7% to $2.16 in pre-market trading after declining around 3% on Monday.</li>
</ul>
<h3>
Losers</h3>
<ul>
<li>Vincerx Pharma, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vinc#NASDAQ">VINC</a>) declined 52.1% to $2.29 in pre-market trading after the company presented preliminary Phase 1 data for VIP236 and updates on pipeline progress at the AACR Annual Meeting 2024.</li>
<li>Focus Universal Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fcuv#NASDAQ">FCUV</a>) fell 30.8% to $0.2424 in pre-market trading. Focus Universal, on Monday, announced Warren Wang as Chief Strategy Officer.</li>
<li>UTime Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/wto#NASDAQ">WTO</a>) fell 26.1% to $0.2216 in pre-market trading. UTime shares jumped 62% on Monday after the company completed a private placement.</li>
<li>BioSig Technologies, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bsgm#NASDAQ">BSGM</a>) fell 22.8% to $0.9570 in pre-market trading after jumping over 96% on Monday.</li>
<li>Guardion Health Sciences, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ghsi#NASDAQ">GHSI</a>) shares declined 20.8% to $7.05 in pre-market trading.</li>
<li>Maxeon Solar Technologies, Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/maxn#NASDAQ">MAXN</a>) fell 16.8% to $2.27 pre-market trading. Maxeon Solar said it sees preliminary fourth-quarter revenue of $229 million versus market estimates of $235.959 million.</li>
<li>Hanryu Holdings, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hryu#NASDAQ">HRYU</a>) shares fell 15.8% to $0.24 in pre-market trading after jumping over 31% on Monday.</li>
<li>VBI Vaccines Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vbiv#NASDAQ">VBIV</a>) fell 12.4% to $0.8037 in pre-market trading after jumping around 30% on Monday.</li>
<li>Eco Wave Power Global AB (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/wave#NASDAQ">WAVE</a>) shares fell 11.2% to $3.73 in pre-market trading. Eco Wave. Power global shares jumped 219% on Monday after the company announced that it was selected by an international energy company to conduct wave energy feasibility studies for the U.S. coastline.</li>
<li>DigiAsia Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/faas#NASDAQ">FAAS</a>) fell 9.9% to $7.00 pre-market trading after surging over 20% on Monday.</li>
</ul>
&nbsp;
Now Read This: <a href="https://www.benzinga.com/news/earnings/24/04/38154597/neogen-maxeon-solar-technologies-and-3-stocks-to-watch-heading-into-tuesday"> Neogen, Maxeon Solar Technologies And 3 Stocks To Watch Heading Into Tuesday</a>

Biotech

General

VBI Vaccines Presents Early Tumor Response Data From Randomized Controlled Phase 2b Study Of VBI-1901 In Recurrent Glioblastoma; Early Data From Patients Eligible For Evaluation At Week 12 Show Two Observations Of Stable Disease, Indicating No Tumor Progression, In VBI-1901 Treatment Arm

Contracts

VBI Vaccines To Expand Strategic Partnership With Canadian Government; Partnership To Direct CAD$28M Of Funding Remaining Under Original CAD$56M Award To Continue Development Of Proprietary Tech Platforms

Shares of Sony Group Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/sony#NYSE">SONY</a>) fell during Wednesday&rsquo;s session after the company reported third-quarter financial results and revised guidance above estimates and shared plans to list its financial arm in October 2025.
Sony Group reported third-quarter FY23 sales growth of 22% year-on-year to $25.34 billion (&yen;3.75 trillion), beating the consensus of $24.62 billion. Adjusted EPS of $1.99 beat the consensus of $1.65.
Sony revised its FY23 sales outlook to $86.62 billion (&yen;12.4 trillion), down from a prior forecast of &yen;12.3 trillion versus the consensus of $87.32 billion.
Sony Group shares fell 6.3% to $89.86 on Wednesday.
Here are some other stocks moving in today&#39;s mid-day session.
<h3>Gainers</h3>
<ul>
<li>Datasea Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dtss#NASDAQ">DTSS</a>) shares jumped 1,173% to $18.59. On Tuesday, Datasea posted a narrower second-quarter loss.</li>
<li>Earlyworks Co., Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/elws#NASDAQ">ELWS</a>) surged 416% to $2.35 on two passive stakes.</li>
<li>enGene Holdings Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/engn#NASDAQ">ENGN</a>) jumped 95.5% to $14.90. The company&rsquo;s CEO Jason Hanson is resigning due to personal family and health reasons, though he will continue to support the company as a strategic advisor after a successor is appointed. Concurrently, enGene announced a private placement of 20 million common shares at $10.00 per share, representing a 31% premium over the previous day&rsquo;s closing price.</li>
<li>Cineverse Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cnvs#NASDAQ">CNVS</a>) surged 92.9% to $2.9899. Cineverse announced forthcoming launch of AI-powered movie search platform cineSearch.</li>
<li>Cheche Group Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ccg#NASDAQ">CCG</a>) gained 74.3% to $5.49.</li>
<li>MGO Global, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mgol#NASDAQ">MGOL</a>) rose 66% to $0.6647.</li>
<li>Cogent Biosciences, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cogt#NASDAQ">COGT</a>) surged 62.7% to $8.89.</li>
<li>Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/iinn#NASDAQ">IINN</a>) gained 35% to $1.29 after the company announced it received the first ever U.S. Patent approval for an orbiting blood oxygenation delivery system, a core technology of the INSPIRA ART500 device.</li>
<li>Lyft, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lyft#NASDAQ">LYFT</a>) shares gained 34.3% to $16.29 after the company reported fourth-quarter sales of $1.22 billion and gross bookings of $3.7 billion, up 17% year-over-year. The company&rsquo;s CFO, Erin Brewer, said the adjusted EBITDA margin is projected to expand 50 basis points in 2024.</li>
<li>Healthcare Services Group, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hcsg#NASDAQ">HCSG</a>) gained 25.7% to $11.90 following upbeat earnings.</li>
<li>Blink Charging Co. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blnk#NASDAQ">BLNK</a>) gained 24.2% to $3.3288. Blink Charging announced preliminary fourth-quarter revenue excess of $42 million.</li>
<li>Larimar Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lrmr#NASDAQ">LRMR</a>) rose 23.9% to $10.83. Larimar Therapeutics has priced the public offering of 17.16 million shares at $8.74 per share for gross proceeds of approximately $150 million.</li>
<li>Clene Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/clnn#NASDAQ">CLNN</a>) gained 22.9% to $0.52.</li>
<li>Angi Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/angi#NASDAQ">ANGI</a>) gained 22.2% to $2.97 following upbeat earnings.</li>
<li>Iris Energy Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/iren#NASDAQ">IREN</a>) shares rose 20.5% to $8.35.</li>
<li>CEVA, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ceva#NASDAQ">CEVA</a>) gained 18.5% to $23.92 following upbeat earnings.</li>
<li>Great Lakes Dredge &amp; Dock Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gldd#NASDAQ">GLDD</a>) gained 17.1% to $9.47 following quarterly results.</li>
<li>Resideo Technologies, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/rezi#NYSE">REZI</a>) rose 16.7% to $19.94 after the company reported better-than-expected quarterly financial results.</li>
<li>Kratos Defense &amp; Security Solutions, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ktos#NASDAQ">KTOS</a>) jumped 15.7% to $20.59 following better-than-expected quarterly results.</li>
<li>Robinhood Markets, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hood#NASDAQ">HOOD</a>) shares gained 14.7% to $13.58 after the company reported better-than-expected fourth-quarter financial results.</li>
<li>United Fire Group, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ufcs#NASDAQ">UFCS</a>) rose 13.5% to $24.32 following upbeat results.</li>
<li>Allison Transmission Holdings, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alsn#NASDAQ">ALSN</a>) gained 13% to $69.53 after the company reported better-than-expected quarterly financial results.</li>
<li>MRC Global Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrc#NYSE">MRC</a>) rose 12.1% to $11.64 following upbeat earnings.</li>
<li>Coinbase Global, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/coin#NASDAQ">COIN</a>) gained 11.5% to $156.50 amid strength in Bitcoin.</li>
<li>CCSC Technology International Holdings Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cctg#NASDAQ">CCTG</a>) shares rose 10.2% to $3.56 after dipping around 10% on Tuesday.</li>
<li>Tower Semiconductor Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tsem#NASDAQ">TSEM</a>) gained 8.5% to $31.07 following strong results.</li>
<li>Sentage Holdings Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sntg#NASDAQ">SNTG</a>) shares jumped 8.4% to $2.46.</li>
<li>Charles River Laboratories International, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/crl#NYSE">CRL</a>) gained 7.2% to $236.00 after the company reported better-than-expected fourth-quarter results and issued guidance above estimates.</li>
<li>VBI Vaccines Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vbiv#NASDAQ">VBIV</a>) shares surged 5.2% to $0.6941. Brii Biosciences agreed to acquire VBI&#39;s IP rights in BRII-179 (VBI-2601) and plans to initiate technology transfer to expand clinical and commercial supplies.</li>
</ul>
<h3>Losers</h3>
<ul>
<li>Azitra, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/aztr#NYSE">AZTR</a>) shares fell 69.5% to $0.2653. Azitra priced its $5 million public offering of 16.667 million common shares at $0.30 per share.</li>
<li>Ohmyhome Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/omh#NASDAQ">OMH</a>) fell 40.7% to $1.3397 after the company priced its upsized $4.8 million public offering of 3,555,555 ordinary shares at $1.35 per share.</li>
<li>QuidelOrtho Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/qdel#NASDAQ">QDEL</a>) fell 34.9% to $43.49 after the company reported worse-than-expected fourth-quarter financial results and issued FY24 adjusted EPS below estimates.</li>
<li>BioNexus Gene Lab Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bglc#NASDAQ">BGLC</a>) shares fell 34.4% to $1.03 after jumping 282% on Tuesday.</li>
<li>Sunworks, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sunw#NASDAQ">SUNW</a>) fell 34.3% to $0.0662.</li>
<li>Enviva Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/eva#NYSE">EVA</a>) fell 33.2% to $0.2977. Enviva is preparing to file for bankruptcy within days, the Wall Street Journal reported.</li>
<li>EpicQuest Education Group International Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/eeiq#NASDAQ">EEIQ</a>) fell 27.5% to $1.16.</li>
<li>Nukkleus Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nukk#NASDAQ">NUKK</a>) shares declined 21.6% to $1.5338 after surging over 55% on Tuesday. Goldman Sachs reported a 7.2% passive stake in Nukkleus as of Dec. 29, 2023.</li>
<li>Upstart Holdings, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/upst#NASDAQ">UPST</a>) fell 20.5% to $26.19 after the company issued first-quarter revenue guidance below estimates.</li>
<li>Esports Entertainment Group, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gmbl#NASDAQ">GMBL</a>) shares fell 20% to $1.48. Esports Entertainment Group announced voluntary delisting from the Nasdaq and transfer to the OTCQB Venture Market.</li>
<li>Qurate Retail, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/qrteb#NASDAQ">QRTEB</a>) declined 18.4% to $4.69.</li>
<li>CAE Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/cae#NYSE">CAE</a>) fell 12.2% to $18.36 after the company reported worse-than-expected quarterly financial results.</li>
<li>The Chemours Company (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/cc#NYSE">CC</a>) dipped 10.5% to $27.29.</li>
<li>Vroom, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vrm#NASDAQ">VRM</a>) fell 10.5% to $13.71.</li>
<li>Maplebear Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cart#NASDAQ">CART</a>) fell 7.8% to $25.67 following quarterly results.</li>
<li>MGM Resorts International (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mgm#NYSE">MGM</a>) shares declined 7.4% to $42.29 after the company reported fourth-quarter financial results.</li>
<li>Akamai Technologies, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akam#NASDAQ">AKAM</a>) fell 7.3% to $115.89 after the company reported mixed quarterly financial results.</li>
<li>The Kraft Heinz Company (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/khc#NASDAQ">KHC</a>) declined 5.5% to $34.13 after the company reported mixed quarterly financial results.</li>
<li>Airbnb, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/abnb#NASDAQ">ABNB</a>) shares declined 5% to $143.25 after the company reported fourth-quarter financial results.</li>
</ul>
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Why Sony Shares Are Trading Lower By Around 6%? Here Are Other Stocks Moving In Wednesday's Mid-Day Session

Shares of Robinhood Markets, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hood#NASDAQ">HOOD</a>) shares rose sharply in today&rsquo;s pre-market trading after the company reported better-than-expected <a href="https://www.benzinga.com/news/earnings/24/02/37107009/robinhood-q4-earnings-highlights-revenue-beat-eps-beat-strong-start-to-q1-and-more">fourth-quarter financial results</a>.
Robinhood reported fourth-quarter revenue of $471 million, which was up 24% year-over-year. The revenue beat a Street consensus estimate of $456.8 million, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>. Robinhood reported earnings per share of 3 cents, which beat a Street consensus estimate of a loss of 1 cent per share.
Robinhood shares jumped 13.8% to $13.47 in pre-market trading
Here are some other stocks moving in pre-market trading.
<h3>Gainers</h3>
<ul>
<li>Brera Holdings PLC (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/brea#NASDAQ">BREA</a>) gained 397% to $5.07 in pre-market trading.</li>
<li>Earlyworks Co., Ltd (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/elws#NASDAQ">ELWS</a>) gained 176.9% to $1.26 in pre-market trading after falling around 8% on Tuesday.</li>
<li>Sentage Holdings Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sntg#NASDAQ">SNTG</a>) shares jumped 107.1% to $4.70 in pre-market trading.</li>
<li>CCSC Technology International Holdings Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cctg#NASDAQ">CCTG</a>) shares rose 82.4% to $5.89 in pre-market trading after dipping around 10% on Tuesday.</li>
<li>Fresh2 Group Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fres#NASDAQ">FRES</a>) shares rose 47.8% to $0.7139 in pre-market trading after gaining around 35% on Tuesday.</li>
<li>VBI Vaccines Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vbiv#NASDAQ">VBIV</a>) shares surged 18.3% to $0.7810 in pre-market trading. Brii Biosciences agreed to acquire VBI&#39;s IP rights in BRII-179 (VBI-2601) and plans to initiate technology transfer to expand clinical and commercial supplies.</li>
<li>Gannett Co., Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gci#NYSE">GCI</a>) shares gained 18.2% to $2.60 in pre-market trading after falling over 5% on Tuesday.</li>
<li>Iris Energy Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/iren#NASDAQ">IREN</a>) shares rose 17.8% to $8.15 in pre-market trading.</li>
<li>Lyft, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lyft#NASDAQ">LYFT</a>) shares gained 17.7% to $14.28 in pre-market trading after the company reported fourth-quarter sales of $1.22 billion and gross bookings of $3.7 billion, up 17% year-over-year. The company&rsquo;s CFO, Erin Brewer, said the adjusted EBITDA margin is projected to expand 50 basis points in 2024.</li>
</ul>
<h3>Losers</h3>
<ul>
<li>Azitra, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/aztr#NYSE">AZTR</a>) shares declined 64.4% to $0.31 in pre-market trading. Azitra priced its $5 million public offering of 16.667 million common shares at $0.30 per share.</li>
<li>QuidelOrtho Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/qdel#NASDAQ">QDEL</a>) fell 32.6% to $45.03 in pre-market trading after the company reported worse-than-expected fourth-quarter financial results and issued FY24 adjusted EPS below estimates.</li>
<li>Ohmyhome Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/omh#NASDAQ">OMH</a>) shares declined 29.2% to $1.60 in pre-market trading. Ohmyhome priced upsized $4.8 million public offering of 555,555 ordinary shares at $1.35 per share.</li>
<li>Nukkleus Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nukk#NASDAQ">NUKK</a>) shares declined 27.6% to $1.42 in pre-market trading after surging over 55% on Tuesday. Goldman Sachs reported a 7.2% passive stake in Nukkleus as of Dec. 29, 2023.</li>
<li>Esports Entertainment Group, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gmbl#NASDAQ">GMBL</a>) shares dipped 27% to $1.35 in pre-market trading. Esports Entertainment Group announced voluntary delisting from the Nasdaq and transfer to the OTCQB Venture Market.</li>
<li>BioNexus Gene Lab Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bglc#NASDAQ">BGLC</a>) shares fell 26.1% to $1.16 in pre-market trading after jumping 282% on Tuesday.</li>
<li>Cheetah Net Supply Chain Service Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ctnt#NASDAQ">CTNT</a>) shares fell 25.4% to $1.26 in pre-market trading.</li>
<li>Upstart Holdings, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/upst#NASDAQ">UPST</a>) fell 19.7% to $26.39 in pre-market trading after the company issued first-quarter revenue guidance below estimates.</li>
<li>BlackLine, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bl#NASDAQ">BL</a>) declined 14.2% to $50.00 in pre-market trading after reporting quarterly results.</li>
<li>Airbnb, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/abnb#NASDAQ">ABNB</a>) shares declined 6.1% to $141.67 in pre-market trading after the company reported fourth-quarter financial results.</li>
</ul>
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BREA

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Why Robinhood Shares Are Trading Higher By Around 14%; Here Are 20 Stocks Moving Premarket

Under these agreements,&nbsp;Brii Bio&nbsp;will issue a&nbsp;$2.5 million&nbsp;promissory note to VBI initially. This will eliminate royalty and milestone payments for PreHevbri. Upon meeting specific conditions, the note will increase to&nbsp;$10 million, securing all of VBI&#39;s intellectual properties (IP) for BRII-179, with associated payments also eliminated. In addition, subject to certain approvals,&nbsp;Brii Bio&nbsp;and VBI will work together to transfer the manufacturing technologies of BRII-179 to a site designated by&nbsp;Brii Bio. Upon completion of essential activities relating to such technology transfer, subject to certain potential adjustments,&nbsp;Brii Bio&nbsp;will issue up to an additional&nbsp;$8 million&nbsp;promissory note to VBI. After satisfaction of certain conditions,&nbsp;Brii Bio&nbsp;will also take control of VBI&#39;s Rehovot-based manufacturing facilities for BRII-179 and PreHevbrio/PreHevbri for&nbsp;$10 million&nbsp;cash on or after&nbsp;June 30, 2024, when&nbsp;Brii Bio&nbsp;and VBI plan to enter into supply agreement under which&nbsp;Brii Bio&nbsp;will become VBI&#39;s commercial supplier for PreHevbrio and PreHevbri.

Brii Biosciences Agrees To Acquire VBI's IP Rights In BRII-179 (VBI-2601) And Plans To Initiate Technology Transfer To Expand Clinical And Commercial Supplies

&nbsp;
As previously disclosed, on November 13, 2023, VBI Vaccines Inc. (the "Company") along with its subsidiary VBI Cda (collectively, the "Borrowers") entered into a forbearance agreement (the "Forbearance Agreement") with K2 HealthVentures LLC ("K2HV") and any other lender from time-to-time party thereto (the "Lenders"), pursuant to which the Lenders agreed to forbear from exercising the Secured Parties' (as defined in that certain Loan and Guaranty Agreement between the Borrowers and the Lenders, dated as of May 22, 2020 (as amended, the "Loan Agreement")), rights with respect to the failure to meet the minimum Net Revenue (as defined in the Loan Agreement) covenant for the measurement period ended September 30, 2023, from November 13, 2023, through and including November 28, 2023 (the "Forbearance Period"), subject to compliance by the Borrowers with certain terms and conditions as set forth in the Forbearance Agreement. Additionally, as previously disclosed, on November 28, 2023, December 12, 2023, and December 26, 2023, effective as of the same dates, the Borrowers and the Lenders agreed to extend the Forbearance Period through and including December 12, 2023, December 26, 2023, and January 9, 2024, respectively, subject to compliance by the Borrowers with the same terms and conditions as set forth in the Forbearance Agreement.
&nbsp;
Effective January 9, 2024, the Borrowers and the Lenders agreed to further extend the Forbearance Period through and including January 23, 2024, subject to compliance by the Borrowers with the same terms and conditions as set forth in the Forbearance Agreement.
&nbsp;
There is no assurance that the Company will be able to meet the conditions set forth in the Forbearance Agreement, which will result in a termination of the Forbearance Period. In addition, the Forbearance Agreement is not a waiver by K2HV of the Company's obligation to meet the covenants pursuant to the Loan Agreement. Accordingly, K2HV may declare an Event of Default after the end of the Forbearance Period, and there is no assurance that the Company would be able to enter into another forbearance agreement for any additional periods. Upon occurrence and during the continuance of an Event of Default, K2HV is entitled to declare all obligations under the Loan Agreement immediately due and payable and to stop advancing money or extending credit under the Loan Agreement, and the applicable rate of interest will be increased by 5.00% per annum.

Financing

VBI Vaccines Inc. Announces The Borrowers And The Lenders Have Agreed To Extend The Forbearance Period Until January 23, 2024, If Conditions Not Met, The Period Will Be Terminated And K2 HealthVentures LLC May Declare An Event Of Default

Shares of Faraday Future Intelligent Electric Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ffie#NASDAQ">FFIE</a>) surged in pre-market trading after the company announced its foray into <a href="https://www.benzinga.com/news/23/11/35936318/faraday-future-expands-into-middle-east-reveals-limited-edition-ff-91-to-debut-during-abu-dhabi-f1-g">the Middle East market</a>.
Faraday Future revealed in press release that the company will release the FF 91 2.0 Futurist aiFalcon, with deliveries starting in 2024.
Faraday Future shares rose 14.1% to $0.5590 in pre-market trading.
Here are some other stocks moving in pre-market trading.
<h3>Gainers</h3>
<ul>
<li>FLJ Group Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/flj#NASDAQ">FLJ</a>) shares rose 126.7% to $0.2451 in pre-market trading. FLJ Group signed a definitive deal to acquire Alpha Mind Technology Limited.</li>
<li>Telesis Bio, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tbio#NASDAQ">TBIO</a>) shares rose 37.1% to $0.5482 in pre-market trading after surging 33% on Wednesday.</li>
<li>iRobot Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/irbt#NASDAQ">IRBT</a>) rose 34.1% to $39.98 in pre-market trading. Amazon.com Inc.&rsquo;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amzn#NASDAQ">AMZN</a>) proposed acquisition of iRobot is reportedly on the verge of receiving unconditional approval from European Union antitrust authorities.</li>
<li>BioNexus Gene Lab Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bglc#NASDAQ">BGLC</a>) shares surged 30.6% to $0.4819 in pre-market trading after falling 3% on Wednesday.</li>
<li>Bruush Oral Care Inc.(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/brsh#NASDAQ">BRSH</a>) gained 29.6% to $0.3305 in pre-market trading after falling around 15% on Wednesday. On Nov. 15, Brush Oral Care received a notice from the Nasdaq Listing Qualifications Department that the company is currently not in compliance with the minimum bid price requirement because the closing bid price of BRSH shares was below $1.00 per share for a period of 30 consecutive business days.</li>
<li>MMTec, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mtc#NASDAQ">MTC</a>) shares climbed 21.3% to $1.19 in pre-market trading. The company recently reported a narrower loss for H1.</li>
<li>VBI Vaccines Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vbiv#NASDAQ">VBIV</a>) rose 16.2% to $0.6389 in pre-market trading after falling around 21% on Wednesday. VBI Vaccines recently posted downbeat quarterly results.</li>
<li>Iveda Solutions, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ivda#NASDAQ">IVDA</a>) shares rose 12.7% to $0.71 in pre-market trading after gaining more than 10% on Wednesday.</li>
<li>UpHealth, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/uph#NYSE">UPH</a>) gained 11.5% to $0.68 in pre-market trading after declining 23% on Wednesday.</li>
</ul>
<h3>Losers</h3>
<ul>
<li>Impel Pharmaceuticals Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/impl#NASDAQ">IMPL</a>) dipped 28.2% to $0.5597 in pre-market trading after jumping 143% on Wednesday. Impel Pharmaceuticals recently announced exploration of strategic alternatives.</li>
<li>Aethlon Medical, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aemd#NASDAQ">AEMD</a>) shares fell 17.2% to $1.40 in pre-market trading. The company recently posted a narrower-than-expected quarterly loss.</li>
<li>WANG &amp; LEE GROUP, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/wlgs#NASDAQ">WLGS</a>) shares fell 15.4% to $0.61 in pre-market trading after declining around 7% on Wednesday.</li>
<li>Reliance Global Group, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/reli#NASDAQ">RELI</a>) fell 13.1% to $1.13 in pre-market after jumping 53% on Wednesday. Reliance Global recently announced it withdrew its proposed underwritten public offering and also announced it has entered into a Letter of Intent to acquire a benefits enrollment company.</li>
<li>Ikena Oncology, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ikna#NASDAQ">IKNA</a>) fell 12.3% to $1.43 in pre-market trading. Ikena Oncology recently reported worse-than-expected third-quarter revenue results.</li>
<li>Seelos Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/seel#NASDAQ">SEEL</a>) fell 11.8% to $0.1498 in pre-market trading after jumping over 30% on Wednesday.</li>
<li>BuzzFeed, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bzfd#NASDAQ">BZFD</a>) shares fell 9.6% to $0.2805 in pre-market trading. The company recently posted downbeat quarterly results.</li>
<li>Heart Test Laboratories, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hscs#NASDAQ">HSCS</a>) fell 9.5% to $0.2137 in pre-market trading after jumping 20% on Wednesday.</li>
<li>Cardio Diagnostics Holdings, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cdio#NASDAQ">CDIO</a>) shares fell 9.1% to $1.99 in pre-market trading. Cardio Diagnostics recently announced the publication of a study on the development and validation of PrecisionCHD in the Journal of the American Heart Association.</li>
<li>Cuentas Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cuen#NASDAQ">CUEN</a>) shares fell 8.7% to $1.26 in pre-market trading after declining 11% on Wednesday. Cuentas recently posted a narrower quarterly loss.</li>
</ul>
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Why Faraday Future Shares Are Trading Higher By Around 14%; Here Are 20 Stocks Moving Premarket

VBI Vaccines Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VBIV#NASDAQ">VBIV</a>) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that additional biomarker data from the Phase 1/2a study of VBI-1901, the Company's cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients, were highlighted in a poster presentation at the 28th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), held on Friday, November 17, 2023.
New proof-of-mechanism data demonstrated that vaccination with VBI-1901 was associated with T-cell activation capable of trafficking across the blood-brain barrier to the tumor microenvironment, an area which is known to be highly immunosuppressive and difficult to infiltrate. The additional peripheral biomarker data assessed levels of C4G – a protein fragment produced when cytotoxic T-cells, or killer T-cells, migrate into and throughout the tumor microenvironment – high baseline levels of which have been associated with longer overall survival in studies conducted in metastatic melanoma patients [Prakash et al., 2014].1 After vaccination with VBI-1901 in the Phase 1/2a study in recurrent GBM patients, the data showed there were higher blood/plasma levels of C4G in patients who achieved partial tumor responses than in patients with stable or progressive disease. Additionally, higher levels of C4G after vaccination with VBI-1901 have been associated with longer progression-free survival.
"We are very pleased to share these significant mechanistic findings at SNO," said David E. Anderson, Ph.D., VBI's Chief Scientific Officer. "The GBM tumor microenvironment is notoriously immunosuppressive and difficult to penetrate, which is why most treatment needs to be administered intratumorally, and why there are currently so few effective treatment options for patients. We believe that these data continue to enrich the potential for VBI-1901 to have meaningful impact in recurrent and primary GBM, and we look forward to data from the next phases of development in each setting."
Data Highlights from Phase 1/2a Study Data in Recurrent GBM Patients- VBI-1901 10µg + GM-CSF Study Arms (n=16)
<ul>
<li>44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR) + complete tumor response (CR)</li>
<li>2 PRs were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline</li>
<li>5 additional patients demonstrated SD for a sustained period of time</li>
<li>All patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months</li>
<li>Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care2</li>
</ul>
Ongoing Phase 2b Study Design in Recurrent GBM Patients Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM
<ul>
<li>Patients will be randomized in a 1:1 ratio across two study arms:
<ul>
<li>Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression</li>
<li>Active comparator: monotherapy standard-of-care – either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity</li>
</ul>
</li>
<li>Endpoints include:
<ul>
<li>Safety and tolerability</li>
<li>Overall survival (OS) – median and overall</li>
<li>Tumor response rate (TRR)</li>
<li>Progression-free survival (PFS)</li>
<li>Immunologic responses</li>
<li>Reduction in corticosteroid use relative to baseline</li>
<li>Change in quality of life compared to baseline</li>
</ul>
</li>
</ul>
The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.3
For more information about the Phase 2b study, visit <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03382977%3Fintr%3DVBI-1901%26rank%3D1&amp;esheet=53859436&amp;newsitemid=20231120733718&amp;lan=en-US&amp;anchor=clinicaltrials.gov&amp;index=1&amp;md5=657f322f7d50bff3f4040ba55fe89897">clinicaltrials.gov</a> and reference trial identifier: NCT03382977.
About GBM and VBI-1901
Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI's enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.

VBI Vaccines Presents Additional Biomarker Data From Phase 1/2a Study Of VBI-1901 In Recurrent GBM At The 2023 Society For Neuro-Oncology 
 Annual Meeting

VBI Vaccines (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VBIV#NASDAQ">VBIV</a>) reported quarterly losses of $(0.38) per share which missed the analyst consensus estimate of $(0.14) by 171.43 percent. This is a 87.33 percent increase over losses of $(3.00) per share from the same period last year. The company reported quarterly sales of $6.62 million which missed the analyst consensus estimate of $13.25 million by 50.01 percent. This is a 1.99K percent increase over sales of $317.00 thousand the same period last year.

Earnings

Earnings Misses

VBI Vaccines Q3 EPS $(0.38) Misses $(0.14) Estimate, Sales $6.62M Miss $13.25M Estimate

<ul>
<li>Preclinical data suggests novel mRNA-launched eVLPs ("MLE") generate significantly enhanced B-cell and T-cell responses compared to mRNA-expression of antigens alone</li>
<li>In addition to immunologic benefits, new MLE technology enables manufacturing of particulate vaccines on an accelerated timeline, similar to other mRNA manufacturing timelines</li>
<li>Based on encouraging data seen to date, MLE proprietary technology is under evaluation by multiple potential partners, including by both pharmaceutical and biotechnology companies</li>
<li>Detailed preclinical data are also being targeted for presentation at a future scientific conference</li>
</ul>
VBI Vaccines Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VBIV#NASDAQ">VBIV</a>) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the development of its next-generation mRNA-launched enveloped virus-like particle (eVLP) technology, which expands on the company's current proprietary eVLP technology by coding the particles in messenger RNA (mRNA). In preclinical studies, VBI's new mRNA-launched eVLP (MLE) technology has demonstrated an ability to generate stronger B- and T-cell signals than those seen with other mRNA vaccines tested. The MLE technology also has the added benefit of streamlined and accelerated chemistry, manufacturing, and control (CMC) processes and manufacturing timelines, similar to other known mRNA vaccine production platforms.
"This innovative approach to vaccine development leverages the strengths of both our eVLP platform and those seen in mRNA vaccine technologies, resulting in a platform that has the potential to produce highly potent, well-tolerated vaccines in an accelerated timeframe," said David E. Anderson, VBI's Chief Scientific Officer. "Our MLE technology uses the human body as a bioreactor to produce complex proteins that mimic the natural viral targets, stimulating a strong functional immune response. We are excited about the preclinical data generated to date and the manufacturing advantages of this technology, promising attributes which would be applied across a broad range of preventive and therapeutic targets."
VBI's MLE Program Highlights:
Multiple animal studies have assessed MLE presentation of target antigens compared to mRNA-expression alone – studies conducted include target antigens from cytomegalovirus (CMV), Epstein-Barr virus (EBV), and coronaviruses
Immunologic Responses – Breadth &amp; Potency:
<ul>
<li>MLE presentation of multiple antigens induced up to 10-fold higher neutralizing antibody responses vs. standard mRNA expression</li>
<li>MLE presentation of multiple antigens enhanced the induction of polyfunctional CD4 and CD8 T-cell responses – balanced, polyfunctional T-cells typically correlate with enhanced efficacy in both preventive and therapeutic settings</li>
<li>Breadth and quality of immune response to MLE technology expand the potential for MLE-targeted therapies across infectious disease, cancer, and allergic and autoimmune disease indications</li>
</ul>
Durability of Immune Response:
<ul>
<li>Mice vaccinated with MLE-coded antigens experienced 12-fold stronger memory recall responses compared to standard mRNA-coded antigens alone, when challenged 7 months following immunization</li>
<li>Rapid immunologic recall responses can have clinical benefit in the form of improved durability of protection as well as protection against viral reactivation</li>
</ul>
Functional Engineering:
<ul>
<li>Leveraging the flexibility of VBI's eVLP technology, target antigens can be expressed both internally and externally with the potential to "tune" the desired immune response</li>
</ul>
About the mRNA-Launched eVLP (MLE) Program
Standard mRNA vaccines are transported to cells in a lipid nanoparticle, carrying instructions in the form of genetic code that teach the immune system to generate proteins that trigger an immune response to a target antigen. VBI's MLE approach adds a structural viral protein core – the same protein at the core of VBI's eVLPs – to an mRNA vaccine. The addition of this protein instructs cells not only to create target antigens, but also to create eVLPs in vivo, which then circulate in the body, provoking the immune system to drive potent B-cell and T-cell responses.
Detailed data are being targeted for presentation at a future scientific conference.

VBI Vaccines Expands Proprietary Technology Platforms With Development Of A Novel mRNA-Launched eVLP Vaccine Program