There's zero time to waste this morning.

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Pressing Technical Update: Nasdaq Breakout Idea (HILS) Makes A Move Early

September 20th

Greetings Readers,

There's zero time to waste this morning.

HILS has just moved above multiple lines of potential resistance and could be on the verge of growing support to continue on this early morning spurt.

With this green move, HILS is now trading above its:

  • 5-Day Simple Moving Average (SMA)
  • 20-Day SMA
  • 5-Day Exponential Moving Average (EMA)
  • 13-Day EMA

This is not to be taken lightly this morning. Keep a close eye on these lines.

Pair that with September's huge news and a low float (fewer than 12Mn shares), and HILS is a breakout idea needing immediate attention.

Read my initial HILS report below and get this Nasdaq profile on radar quickly.

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*Hillstream BioPharma, Inc. (HILS)*

Hillstream BioPharma, Inc. is a biotechnology company developing a focused portfolio of therapeutic candidates targeting drug resistant and devastating cancers.

The Company’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2 monoclonal antibody targeting unique epitopes with a novel mechanism of action.

And based on these several potential catalysts, HILS needs immediate attention. Check them out:

No. 1 - A Low Float Could Lead To Explosive Volatility (Again!)

No. 2 - Company Enters Agreement To Acquire Key Asset (Itching May Be Meeting Its Match)

No. 3 - HillStream Expands Collaboration And License Agreement To Advance Game-Changing "Knob" Biologics

No. 4 - A Pipeline Reprioritization Aims To Provide Near-Term Value Creation

No. 5 - Exclusive Agreement With Leading Institute Will Help Build Antibody Platform To Advance Pipeline

But more on those in a second...

Hillstream BioPharma's Mission

To improve and transform the lives of patients with drug resistant and devastating rare cancers, through our cutting-edge drug development platform.

Lead Program: HSB-3215 (HER2/HER3 Bispecific Antibody)

Background

  • HER2/neu is a tumor-specific oncogene that has been extensively studied
  • HER3 promotes metastasis & drug resistance by interacting with HER2 (and other receptors) drastically
  • HER2 and HER3 are overexpressed in multiple solid tumors including breast, GI, ovarian, and bladder, colon and other sites associated with a highly aggressive infiltrating type of tumor prone to metastatic spreading

Opp.

  • HER3 has poor to no oncogenic activity alone
  • HER3 heterodimerizes preferentially with HER2 and/or EGFR, which dramatically enhance transphosphorylation and the consequent activation of mitogenic downstream pathways

HSB-3215 (HER2 x HER3 bispecific antibody)

  • Bispecific mAb selective for both HER2 & HER3
  • Platform molecule with follow-on antibody-drug conjugates
  • IND Filing: planned for late 2024

Solid Tumor Pipeline: Validated Targets & Unmet Needs

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HSB-3215: anti-HER2/HER3 bispecific Ab

The ErbB family of cell surface proteins are some of the most well-known and validated oncology drug targets including ErbB2 or HER2 (human epidermal growth factor receptor) and Erb3 or HER3. The family of antibodies and biologics against HER2 starting with HERCEPTIN® (trastuzumab) approved in 1998 for breast cancer, one of the first few anti-cancer antibodies, as well as PERJETA®, KADCYLA® and PHESGO® totaled $8.4Bn in 2022 sales for Roche/Genentech. Antibodies against HER2 and HER3 bind to different domains of the extracellular portion of the proteins or epitopes with trastuzumab binding domain IV of HER2 primarily. HER2 is also one of the most utilized targeting antigens for antibody drug conjugates to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s PERJETA® and Daiichi Sankyo/AstraZeneca’s ENHERTU®.

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The Applied Biomedical Science Institute has developed technology to target unique functional epitopes of the cancer targets HER2 and HER3. Monoclonal antibodies being developed at ABSI are unique from the currently approved anti-HER2 antibodies. ABSI has granted under an exclusive option agreement to Hillstream, certain of its proprietary technology which if converted to an exclusive license agreement, will allow Hillstream to develop HER2 and HER3 antibodies, including multi-specific and Quatramer- based therapeutics incorporating portions of the antibodies.

HSB-0059: Bispecific ADC

Antibody Drug Conjugates (ADCs) are a class of newly emerging therapeutics which may serve as “magic bullets” to treat certain cancers. They consist of a 1) a cancer killing chemotherapeutic payload, 2) an antibody-targeting a cancer cell and 3) a linker connecting the antibody to the payload. The problem with some ADCs targeting HER2 and/or HER3 essentially target the same epitopes as trastuzumab based domains. Our solution based on data an HSB-3215 (HER2/HER3) mAb backbone with HSB-0059 targets novel epitopes on HER2 while blocking natural ligands to HER3 and/or preventing heterodimers. ADCs can also have a potential “bystander effect” of its’ toxin payload. We intend to design ADCs whereby the toxin delivered to surrounding non-antigenic cancer tissue can be killed and maximize antitumor potential for this novel compound.

HSB-1940: Anti-PD-1 (Undruggable Epitopes)

Picobodies are antibody “knob” domains comprised of cysteine-rich ultralong complementary determining region (CDR) H3 sequences of 30-40 amino acids, which have the potential to access challenging epitopes better than full size antibodies can. By combining Quatramers with their long half-life coated with a PD-1 Picobody™ to create HSB-1940, we intend to efficiently target novel epitopes with greater binding affinity than approved biologics.

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Antibodies derived from mouse or human sources use the surface formed by complementarity determining regions (CDRs) on the variable regions of the heavy chain/light chain heterodimer, which typically forms a relatively flat binding surface. Alternative species, particularly camelids and bovines, provide a paradigm for antigen recognition through novel domains which form the antigen binding site. However, for camelids, heavy chain antibodies bind antigen with only a single heavy chain variable region, in the absence of light chains. Meanwhile, in bovines, ultralong CDR-H3 regions form an independently folding mini-domain, which protrudes far out from the surface of the antibody and forms a “stalk and knob” structure which is diverse in both its sequence and disulfide patterns. The “knob” (Picobody) component can be expressed as an independent antigen binding domain. At ~4-6 kDa, these are three times smaller than a camelid “nanobody”, and are the smallest known antibody fragment. These atypical antigen binding sites of bovines potentially provide the ability to interact with different antigenic determinants, particularly recessed or concave surfaces, compared to traditional antibodies.

Sources: Company Website. Company Presentation.

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As mentioned above, HILS needs your full focus now based on several potential catalysts. Check them out:

No. 1 HILS Potential Catalyst - A Low Float Could Lead To Explosive Volatility (Again!)

According to the Yahoo Finance website, HILS has a low float.

The website reports this profile to have roughly 11.46Mn shares in its float.

Why is that important? It's important on one crucial level. Volatility.

Could more positive 2023 company news help provide a near term spark?

Remember: This was an explosive breakout idea previously that ran approximately 100+% in the short term after I brought it to your attention earlier this year.

A low float may have created the potential for such a volatile move...

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No. 2 HILS Potential Catalyst - Company Enters Agreement To Acquire Key Asset (Itching May Be Meeting Its Match)

Hillstream Enters into an Exclusive Option Agreement to Acquire a Clinical Stage Asset for Chronic Pruritis

Anticipate completion of Phase 1 & Phase 2 clinical trials in chronic pruritis over the next approximately 12 months

Seeking first approval in an orphan disease, PBC, for the treatment of moderate to severe chronic pruritis in which more than 70% of patients suffer from chronic pruritis

BRIDGEWATER, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancer announces an exclusive option agreement to acquire a clinical stage asset, AV104, with a recently approved IND. AV104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or “uncontrollable itching.” The Company intends to first seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis in patients with primary biliary cholangitis (PBC), a rare form of liver disease with no known cure in which more than 70% of patients suffer from chronic pruritis.

...

Hillstream believes AV104 has expansion opp's in treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver related and as non-liver related diseases including fatty and alcoholic liver diseases, non-alcoholic liver diseases and certain types of hepatitis. Chronic pruritis is significant in liver diseases as well as chronic kidney diseases, hemodialysis and atopic dermatitis.

The past year has been a period of transformational change for our company,” said Randy Milby, CEO of Hillstream. “This exclusive option allows the company to bring a clinical-stage asset into the organization as we shift into a patient-focused biotechnology organization. This signifies our next step as we grow into a business model focused on clinical development.

Read the full article here.

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No. 3 HILS Potential Catalyst - HillStream Expands Collaboration And License Agreement To Advance Game-Changing "Knob" Biologics

Hillstream Advances Next-Gen Multispecific Antibodies for Solid Tumors with Lead HER2/HER3 Program, HSB-3215

Collaboration adds multiple modular swappable antigen recognition regions to lead program, HSB-3215, a bispecific antibody targeting novel epitopes on HER2/HER3 receptors

Capitalizes on “Knob” biologics (PicobodiesTM) for tumor targeting, extends partnership to include validated target, HER3

IND filing for HSB-3215 planned in 2024

BRIDGEWATER, N.J., July 20, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (“Hillstream”, the “Company”) today announced the expansion of its collaboration with Minotaur Therapeutics, Inc. (“Minotaur”) and its license agreement with OmniAb, Inc. (“OmniAb”) to advance the development of next generation targeted Knob biologics (PicobodiesTM) against HER3 and a new undisclosed oncology target. Hillstream will collaborate with Minotaur using OmniAb’s “OmniTaur™” technology to discover targeted biotherapeutic Picobodies complimenting Hillstream’s most advanced program, HSB-3215, a HER2/HER3 bispecific antibody (BsAb).

...

Dr. Vaughn Smider, Founder and Chief Executive Officer of Minotaur, stated “We are excited to continue Minotaur’s collaboration with Hillstream to progress novel next-generation targeted cancer biologics.

Randy Milby, Chief Executive Officer of Hillstream, stated, “We are extremely pleased with the progress made to date. The Knob biologics program continues to be a great addition to our portfolio as we rapidly progress our lead asset HSB-3215 towards an IND. Hillstream is now poised to develop a novel technology for creating multiple proteins to enhance targeted cancer immunotherapy.

Read the full article here.

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No. 4 HILS Potential Catalyst - A Pipeline Reprioritization Aims To Provide Near-Term Value Creation

Hillstream BioPharma Announces Strategic Reprioritization of Pipeline to Targeting HER2/HER3 Solid Tumors via Bispecific and ADC Antibodies and Biologics

Lead bispecific antibody, HSB-3215 designed to target novel conformational epitopes on high value validated targets, HER2 and HER3

Focus on optimizing ADCs to generate a more potent Bystander Effect and proprietary novel bovine-derived biologic platform, PicoKnobTM, targeting undruggable epitopes on PD-1 and TROP2

Experienced biopharmaceutical executive joins as Chief Operating Officer to spearhead execution of ADC and biologic strategy

BRIDGEWATER, N.J., July 10, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma (Nasdaq: HILS) a biotechnology company developing innovative therapeutic candidates targeting drug resistant and devastating cancers that can make a difference in patients’ lives, today announced a strategic reprioritization of its pipeline and provided a corporate update. The strategic assessment took into account, the pipeline’s near-term value creation opp. and other factors. Hillstream will focus its pipeline on advancing novel oncology assets with the greatest potential and strong competitive profiles to address unmet needs across multiple solid tumors, such as bispecific antibodies and ADCs targeting novel conformational epitopes on high value validated targets, HER2 and HER3, with a more potent Bystander Effect.

...

Hillstream’s lead asset, HSB-3215 is designed as a bispecific humanized immunoglobulin containing two arms targeting the extracellular domains of HER2 and HER3. HSB-3215 binds to both overlapping and different epitopes on HER2 when compared to trastuzumab, the first approved antibody against HER2, while adhering to novel epitopes on HER3, thus creating novel conformational epitopes. The Company intends to develop this novel BsAb and file an IND application with the US FDA late next year.

By exploiting the “Bystander Effect”, a key aspect of ADCs which has been recently highlighted by the improved clinical efficacy of Daiichi Sankyo/AstraZeneca’s ENHERTU® (trastuzumab deruxtecan), the Company plans to optimize its BsAb pipeline with BiSpecific ADCs, i.e. BiSpecific antibodies conjugated with novel toxin payloads which are optimized to generate a more powerful Bystander Effect. ADCs are comprised of a targeting antibody chemically conjugated via a proprietary linker to a powerful, cancer-killing compound/toxin (payload). With a BsAb backbone utilizing HSB-3215, the Company intends to develop novel ADCs, targeting HER2/HER3 and better direct a payload to cancer cells overexpressing these receptors, while healthy cells don’t take up the unwanted compound.

Hillstream also intends to further enhance its previously announced collaborations with Applied Biomedical Science Institute (ABSI) and Minotaur to develop novel bovine-derived biologics in multiple formats against highly validated targets, including PD-1, HER2 and TROP-2, referred to as PicoKnobsTM. An update regarding these collaborations will be announced during an R&D Day in the third quarter.

Our recently announced collaborations with ABSI are transforming Hillstream into a focused and targeted cancer biologics company,” said Randy Milby, Chairman and CEO of Hillstream. “With the HER2 and HER3 platform, we are building a diverse foundation of targeted biologics which can be utilized for our current portfolio as well for future in-licensed assets. We are confident that our focused approach and experienced management team best positions us for success.

The Company also announced the appointment of Sireesh Appajosyula, Pharm. D .as as Chief Operating Officer (COO). Sireesh brings over 20 years of experience in creating and advising biotechnology companies such as 9 Meters Biopharma Inc. through targeted transactions thus creating a pipeline as well as accessing the public capital markets. He was responsible for corporate development including portfolio strategy, in-licensing transactions and alliances for 9 Meters’s core assets as well as monetization of non-core assets. Previously, he spent eight years at Salix Pharmaceuticals, Inc. in various roles including medical & clinical affairs, product commercialization and business development culminating in Salix’s acquisition for $16Bn by Bausch Health. Prior to Salix, Sireesh held increasing roles and responsibilities at Amgen, Chiesi (Critical Therapeutics) and Sanofi S.A. (Aventis). Sireesh holds a Doctor of Pharmacy degree from the Ernest Mario College of Pharmacy at Rutgers University in New Jersey.

I am thrilled to join Hillstream and look forward to working alongside the team as we further our development programs. I believe the Company’s precision oncology strategy with the current HER2/HER3 antibody programs and pipeline have the potential to bring much needed treatments to cancer patients,” said Dr. Appajosyula.

Read the full article here.

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No. 5 HILS Potential Catalyst - Exclusive Agreement With Leading Institute Will Help Build Antibody Platform To Advance Pipeline

Hillstream BioPharma Licenses Technology to Develop Proprietary HER2 and HER3 Antibody Drug Conjugates against Drug-Resistant Breast, Lung, Gastric, and Ovarian Cancers

Anti-HER2 and Anti-HER3 monoclonal antibodies designed to have a high drug-to-antibody ratio intended enhance the bystander killing effect and be effective against a number of epithelial tumors

Antibody CDRs against HER2 and HER3 Conformational Domain Bridging Epitopes can be used in multiple formats including bi- and tri-specific antibodies, antibody drug conjugates (ADCs), CAR-T and CAR-NKs

BRIDGEWATER, N.J., July 06, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using immuno-oncology targeted novel biologics, today announced the signing of an exclusive agreement with Applied Biomedical Science Institute (ABSI) to license technology for human antibodies targeting novel HER2 and HER3 Conformational Epitopes. The goal is to develop proprietary multi-format biologics, including bi-specific antibodies, and antibody drug conjugates (ADCs). The HER2/HER3 binding ADC is targeted to have a high drug-to-antibody ratio which should increase the anti-tumoral efficacy with an enhanced bystander killing effect. Hillstream intends to combat drug resistant cancers such as HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer.

The ErbB family of cell surface proteins, including ErbB2 or HER2 (human epidermal growth factor receptor) and Erb3 or HER3, are some of the most well-known and validated oncology drug targets. Antibodies and biologics against HER2 starting with HERCEPTIN® (trastuzumab) approved in 1998 for breast cancer, and PERJETA®, KADCYLA® and PHESGO® generated $8.4Bn in 2022 sales for Roche/Genentech. These antibodies bind to domains II or IV of the extracellular portion of the HER2. HER2 is also one of the most validated antigens for antibody drug conjugates (ADCs) to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s KADCYLA® and Daiichi Sankyo/AstraZeneca’s ENHERTU®.

The Applied Biomedical Science Institute has developed technology to target novel functional epitopes of the cancer targets HER2 and HER3. The monoclonal antibodies being developed at ABSI are distinct from the currently approved anti-HER2 antibodies. ABSI has granted Hillstream an exclusive license agreement, and Hillstream will have the opportunity to develop HER2 and HER3 antibodies, including multi-specific, ADC, and Quatramer-based therapeutics utilizing portions of these antibodies.

We look forward to this opp. to work with Dr. Smider and the Applied Biomedical Science Institute,” said Randy Milby, CEO of Hillstream. “This agreement allows us to build our antibody platform to advance our immune-oncology biologic pipeline with HER2 and HER3 with bi-specifics and ADC agents targeting highly aggressive drug-resistant metastatic tumors, which represents a major unmet need for patients.

Read the full article here.

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HILS Recap - The Top Potential Breakout Catalysts To Know Right Now

No. 1 - A Low Float Could Lead To Explosive Volatility (Again!)

No. 2 - Company Enters Agreement To Acquire Key Asset (Itching May Be Meeting Its Match)

No. 3 - HillStream Expands Collaboration And License Agreement To Advance Game-Changing "Knob" Biologics

No. 4 - A Pipeline Reprioritization Aims To Provide Near-Term Value Creation

No. 5 - Exclusive Agreement With Leading Institute Will Help Build Antibody Platform To Advance Pipeline

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Coverage is reinitiated on HILS. When you have a chance, do this:

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Get HILS on your radar now.

Sincerely,

Kai Parker

StockWireNews


(Always Remember The Stock Prices Could Be Significantly Lower Now From The Dates I Provided.)

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