Nasdaq: IMMX Profile

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U.S. Food and Drug Administration Has Approved Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children

IMMX HAS JUST 7.5 MILLION OUTSTANDING AND 1.29 MILLION IN THE FLOAT

IMMX JUST RECENTLY IPO’d LAST MONTH WITH PROCEEDS OF $21 M

ImmixBio Announces Positive IMX-110 Phase 1b/2a Interim Clinical Trial Safety Data Demonstrating 100% Completion of Planned Treatment Cycles

READ THE INVESTOR PRESENTATION HERE

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Hello Everyone,

We wanted to update you regarding one of our recent Nasdaq profiles from last month.  We showed you this one right around the time the market in general tanked big time, before the strong rebound.  

The company has released several key announcements over the past month since we last looked at IMMX.

More importantly,  short interest has exploded setting up a potential squeeze upon a reversal.

IMMX is a brand new IPO in the biopharma sector that we think should be on your radar immediately.  The company began trading on the NASDAQ just over a month ago on December 16th and the IPO closed on December 20th with an offering of 4,200,000 shares of its common stock at a price of $5.00.  The total gross proceeds were roughly $21M.

The IPO is less than 2 months old and like often happens, the company shares declined over the first couple weeks to under $3.50/share. On Jan 3 the company announced that its lead product candidate, IMX-110 was granted Rare Pediatric Disease (RPD) designation by the Food and Drug Administration for the treatment of pediatric cancer.

IMMX exploded on the news and closed that day above $5.75, remaining near that price since then.

The company is pioneering a novel class of Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases. Their proprietary System Multi-Action RegulaTors SMARxT Tissue-SpecificTM Platform produces drugs that accumulate at intended therapeutic sites at 3-5 times the rate of conventional medicines. Their TME Normalization™ Technology allows our drug candidates to circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all components of the tumor micro-environment, or TME.  They have uncovered fundamental biological systems that link oncology and immuno-dysregulated diseases. In addition to oncology, our pipeline includes Tissue-Specific BiologicTM candidates to treat inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.

RECENT NEWS:

ImmixBio Announces Positive IMX-110 Phase 1b/2a Interim Clinical Trial Safety Data Demonstrating 100% Completion of Planned Treatment Cycles

100% of Patients On IMX-110 Completed Planned Treatment Cycles

Immix Biopharma, Inc. (NASDAQ:IMMX)
Immix Biopharma, Inc. (NASDAQ:IMMX)
  • 100% of patients treated with IMX-110 completed planned treatment cycles without drug-related interruptions in its ongoing Phase 1b/2a clinical trial
  • IMX-110 is in clinical development as a monotherapy for soft tissue sarcoma (STS), a $3 billion market expected to grow to $6.5 billion by 2030

LOS ANGELES, Jan. 19, 2022 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, today announced positive interim clinical trial safety data demonstrating 100% completion of IMX-110 planned treatment cycles in its ongoing Phase 1b/2a clinical trial. Historically, 43-67% of patients have completed planned treatment cycles with approved drugs used to treat soft tissue sarcoma (STS) according to Demetri et al., 2016, and Schöffski et al., 2016. Completion of planned treatment cycles refers to lack of drug-related interruptions (cycle delays, dose reductions, or dose interruptions due to drug toxicity).

“With standard treatments widely used today, cancer patients face a long list of drug-related debilitating side-effects that cause treatment delays, dose reductions, or dose interruptions due to toxicity, interfering with the ability to treat them effectively,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “In this interim clinical trial update, we are thrilled to report that IMX-110 has been well tolerated. We believe that IMX-110 could become a potentially attractive option to improve the patient experience in oncology in the future.”

The U.S. Food and Drug Administration (“FDA”) has approved orphan drug designation (“ODD”) for IMX-110 for the treatment of soft tissue sarcoma. The FDA has already approved rare pediatric disease (“RPD”) designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

PIPELINE

Clinical Trials

Our lead candidate IMX-110, a potential first-line therapy for soft tissue sarcoma, is currently in clinical trials as a monotherapy, and is planned to be combined with tislelizumab (BeiGene anti-PD-1) for advanced solid tumors. IMX-111 and IMX-120 clinical trials are planned in oncology and immuno-dysregulated diseases, respectively.

U.S. Food and Drug Administration Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children

  • Rare Pediatric Disease Designation (“RPDD”) qualifies Immix Biopharma to receive fast track review, and a priority review voucher (“PRV”) at the time of marketing approval of IMX-110.
  • PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA.
  • While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350 million according to a January 2020 report on drug development by the Government Accountability Office.

LOS ANGELES, Jan. 03, 2022 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening form of pediatric cancer in children, rhabdomyosarcoma. IMX-110, an investigational product, is currently being evaluated in a Phase 1b/2a clinical trial.

The FDA grants Rare Pediatric Disease designation for serious and life-threatening diseases that primarily affect children aged 18 years or younger and impact fewer than 200,000 people in the United States.

If a New Drug Application in the United States for IMX-110 is approved, ImmixBio may be eligible to receive a Priority Review Voucher (PRV) from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application, or may be sold or transferred.

“We are pleased by FDA’s acknowledgment of the urgent need for a safe and effective treatment for children with this devastating disease,” stated ImmixBio’s Chief Executive Officer Ilya Rachman, M.D., PhD. “We are encouraged by our Phase 1b/2a clinical data in soft tissue sarcoma. IMX-110 is a tissue-specific therapeutic that simultaneously attacks all 3 components of the tumor micro-environment, severing the critical lifelines between the tumor and its metabolic and structural support. We believe our SMARxT platform generating Tissue-Specific Therapeutics represents a distinct alternative to the traditional ‘single target, single mutation’ development model.”

Rhabdomyosarcoma (“RMS”) is a high-grade, malignant neoplasm, the most common soft tissue sarcoma in pediatric and adolescent populations and which rarely occurs in adults. The prevalence of RMS in the United States is approximately 20,000 children of all ages. The five-year survival rate ranges from 20% to 30% for children in the high-risk group where cancer spreads widely in the body.

IMX-110 is the first clinical-stage product of ImmixBio’s SMARxT Tissue-Specific™ Platform, which produces Tissue-Specific Therapeutics that accumulate at intended therapeutic sites at 3 to 5 times the rate of conventional medicines. The FDA has already granted orphan drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma.

ImmixBio recently shared clinical data across multiple soft tissue sarcoma subtypes in several heavily pretreated patients demonstrating median progression-free survival (PFS) of 4 months with zero drug-related severe adverse events and zero dose interruptions due to toxicity. The data can be viewed in the Immix Biopharma Corporate Presentation at http://www.immixbio.com/pres

MORE NEWS

ImmixBio Management Answers Top-Voted Investor Questions at IMMX Investors Day February 1, 2022

LOS ANGELES, Feb. 01, 2022 — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, today announced that management has answered top-voted questions submitted by verified IMMX shareholders at the IMMX Investors Day […]

ImmixBio Initiates IMX-110 GMP Manufacturing Scale-Up, Potentially Accelerating Clinical Trial Data

January 31, 2022 08:00 ET | Source: Immix Biopharma, Inc. – Manufactured IMX-110 to be utilized in both clinical trials: – 2022 planned monotherapy IMX-110 Clinical Trial in soft tissue sarcoma (“STS”) – 2022 planned combination IMX-110 + BeiGene anti-PD-1 tislelizumab Clinical Trial in advanced solid […]

IMX-110 + anti-PD-1 Combination Produced Extended Median Survival in Genetic Pancreatic Cancer Mouse Model, Bolstering Planned 2022 IMX-110 Combination Clinical Trial Rationale

– IMX-110 + anti-PD-1 produced 63-day median survival in a genetic (KPC) pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system – Historically, 42-days is the median survival produced by a 4-drug combination of 2 chemotherapies and […]

ImmixBio Announces Positive IMX-110 Phase 1b/2a Interim Clinical Trial Safety Data Demonstrating 100% Completion of Planned Treatment Cycles

– 100% of patients treated with IMX-110 completed planned treatment cycles without drug-related interruptions in its ongoing Phase 1b/2a clinical trial – IMX-110 is in clinical development as a monotherapy for soft tissue sarcoma (STS), a $3 billion market expected to grow to $6.5 billion by […]

ImmixBio IMX-110 Produced 50% Positive Response Rate in First-Line-Therapy-Resistant Cancer, Surpassing the Standard of Care in Mice Study

– IMX-110 produced a 50% response rate after 1 cycle of treatment as a monotherapy in first-line-therapy-resistant cancer – soft tissue sarcoma (STS) mice study – IMX-110 response rate surpassed standard of care doxorubicin’s response rate of 0% after 1 cycle of treatment in the same […]

ImmixBio IMX-110 Produced 50% Positive Response Rate in First-Line-Therapy-Resistant Cancer, Surpassing the Standard of Care in Mice Study

– IMX-110 produced a 50% response rate after 1 cycle of treatment as a monotherapy in first-line-therapy-resistant cancer – soft tissue sarcoma (STS) mice study – IMX-110 response rate surpassed standard of care doxorubicin’s response rate of 0% after 1 cycle of treatment in the same […]

Immix Biopharma Announces IMMX Investors Day to be Held on February 1, 2022 + Q&A Platform for All Shareholders

Los Angeles, CA, Jan. 06, 2022 — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, today announced the IMMX Investors Day Event, to be held on February 1, 2022, and the launch […]

U.S. Food and Drug Administration Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children

January 03, 2022 08:00 ET | Source: Immix Biopharma, Inc. – Rare Pediatric Disease Designation (“RPDD”) qualifies Immix Biopharma to receive fast track review, and a priority review voucher (“PRV”) at the time of marketing approval of IMX-110. – PRV holders can benefit from an expedited […]

Immix Biopharma, Inc. Announces Closing of Initial Public Offering

LOS ANGELES, CA, Dec. 20, 2021 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, today announced the closing of its initial public offering of 4,200,000 shares of its common […]

Immix Biopharma, Inc. Announces Pricing of Initial Public Offering

LOS ANGELES, Dec. 15, 2021 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, announced today the pricing of its initial public offering of 4,200,000 shares of its common stock […]

ImmixBio Announces FDA Orphan Drug Designation for IMX-110 for the Treatment of Soft Tissue Sarcoma

Sep 30, 2021, 08:38 ET LOS ANGELES, Sept. 30, 2021 /PRNewswire/ — Immix Biopharma, Inc. (“ImmixBio”), a biotechnology company pioneering Tissue Specific Therapeutics (TSTx)TM for oncology and inflammation, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to IMX-110 […]

ImmixBio Announces Clinical Trial and Supply Agreement with BeiGene to Evaluate Combination of IMX-110 and Tislelizumab in Solid Tumors

Novel Approach Combining ImmixBio Tissue Specific Therapeutics (TSTx)™ with Immunotherapies Could Expand the Population Of Cancer Patients Experiencing Extended Remissions News provided byImmix Biopharma, Inc.Aug 27, 2021, 08:31 ET LOS ANGELES, Aug. 27, 2021 /PRNewswire/ — Immix Biopharma, Inc. (“ImmixBio”) today announced a clinical trial and […]

ImmixBio Announces Dr. Galit Lahav of Harvard Medical School Joins Scientific Advisory Board

Dr. Galit Lahav, pioneer of understanding why individual human cancer cells often show different responses to the same treatment (including p53 and NF-kB signaling dynamics), and identifying new therapies that will increase the efficacy of anti-cancer drugs News provided byImmix Biopharma, Inc.Aug 17, 2021, 08:44 ET […]

ImmixBio Announces Dr. George W. Sledge of Stanford University Medical Center Joins Scientific Advisory Board

Dr. George W. Sledge, former ASCO president, pioneering clinical investigator of multiple approved cancer therapeutics including multi-kinase inhibitor abemaciclib (marketed as VERZENIO® by Eli Lilly) and paclitaxel News provided byImmix Biopharma, Inc.Aug 09, 2021, 08:38 ET LOS ANGELES, Aug. 9, 2021 /PRNewswire/ — Immix Biopharma, Inc. […]

ImmixBio Announces Dr. Jane Buchan Joins Board of Directors

Jul 28, 2021, 08:48 ET LOS ANGELES, July 28, 2021 /PRNewswire/ — Immix Biopharma, Inc. (“ImmixBio”), a biotechnology company pioneering Tissue Specific Therapeutics (TSTx)™ for oncology and inflammation, today announced that world-renown institutional asset manager and well-recognized investment leader Jane Buchan, PhD has joined the Company’s Board […]

Sincerely,

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