SYN Acquires Novel Oncology Biotech VCN Biosciences And Still Has $65M Cash And A Rich And Growing Pipeline. SYN Investors Could Enjoy Potential 500% Gains In 1H 2022

Summary

• Synthetic Biologics scored a major coup in my opinion when it acquired novel oncology concern VCN Biosciences at the time when owner Grifols was unloading non-core assets.
• The upfront $7M the company spent to acquire a rich, growing, and diverse oncology pipeline is virtually nothing when compared to the initial $500M 2020 IPO of lesser competitor Oncorus.
• Founding shareholders and minority holders of 13.17% of VCN's capital will receive 19.9% of Synthetic Biologics ordinary shares thus incentivizing them to ensure a bright future for the combined enterprise.
• Following the VCN acquisition the company still has about $65M in cash which will provide significant runway to both support the company's existing programs, as well as to able to advance VCN-01 and VCN-011 through important milestones that will certainly drive significant shareholder value.
• VCN was founded by internationally recognized experts in oncolytic adenoviruses for cancer treatment. VCN's novel therapies allow for a robust and efficient manufacturing process, with an attractive cost structure. The platform is supported by a growing intellectual property (IP) portfolio that provides it patent protection through at least 2030 with additional patents underway that will further strengthen the company's IP portfolio.

Discussion

True to his word, Synthetic Biologics CEO Steven Shallcross found the gem he was looking for in the purchase of VCN Biologics. During the November 3, 2021 conference call he responded to an analyst's question as follows:

"So Jim, thanks for the question. Good to hear from you. The only thing I could say at this point is that we have been very, very active in evaluating a number of exciting opportunities. We are in various stages of diligence. These things take time. And outside of that, I just really can't give any specific details on timing. There are always unknowns that come up along the way as you're evaluating ideas. And I can assure you that our team is working very, very hard. I can tell you that over the last year or so, up until today, we've probably evaluated several dozen ideas and we do have a short list. We are, again, in a process and as soon as we are ready to talk publicly about it, we'll get that news out."

Fast forward to December 14, 2021 when Synthetic Biologics, Inc. (NYSEAM:SYN) announced that it has signed a definitive agreement to acquire VCN Biosciences SL from Grifols for a consideration which consists of $4.7M in cash up front, the assumption of $2.4M of VCN liabilities which include certain loans from the Spanish Government and the Catalan Government Agency, and also an additional $70.25M of payments contingent upon the achievement of future milestones, a majority of which are tied to late-stage clinical development and regulatory achievements.

Importantly, the founding shareholders and other minority holders of 13.17% of VCN's capital will receive ordinary shares of Synthetic Biologics, which represent 19.99% of its total outstanding ordinary shares. This obviously means that they  have significant vested interest and a strong desire to help SYN shares move up going forward.

The transaction is expected to close during the first quarter of 2022, and is subject to, among other things, the approval by the Spanish government of the Company's acquisition of VCN under Spain's Foreign Investment Act and other customary closing conditions. A.G.P/Alliance Global Partners and Griffin Securities, Inc. served as financial advisors to Synthetic’s board of directors and Tungsten Partners LLC served as financial advisor to VCN.

VCN Biosciences uses a technological platform based on oncolytic adenoviruses or virotherapy. Viral therapy is a therapeutic approach for the treatment of cancer, based on the use of oncolytic viruses that are capable of replicating and selectively destroying tumor cells.

This novel class of targeted anticancer agents has a unique mechanisms of action compared to other cancer drugs. Oncolytic viruses can detect cancer mutations, replicate or self-amply within cancer cells, lyse them thereby killing them and then propagate the oncolytic effect to neighboring cancer cells. The therapeutic effect is therefore amplified within tumors reducing the viral dose needed to reach tumors while minimizing adverse effects on normal cells.

SYN  CEO Steven Shallcross commented on the acquisition:

"VCN was founded by internationally recognized experts in oncolytic adenoviruses for cancer treatment and I will be delighted to welcome them to our team. VCN's novel therapies allow for a robust and efficient manufacturing process, with an attractive cost structure. The platform is supported by a growing intellectual property (IP) portfolio that provides it patent protection through at least 2030 with additional patents underway that we believe would further strengthen our IP portfolio. Importantly, VCN-01 has been granted Orphan Drug Designation by the European Medicines Agency (EMA), which may provide a number of benefits including up to ten years of market exclusivity. Importantly, we have a strong balance sheet with over $72.1 million of cash as of September 30, 2021, which we believe will provide us significant runway to both support our existing programs, as well as to able to advance VCN-01 and VCN-011 through important milestones that we believe will drive significant shareholder value."

Manel Cascalló, PhD, Chief Executive Officer of VCN, added:

"Joining together with Synthetic Biologics is a significant opportunity as it allows us to partner with an experienced team, well-versed in drug development, manufacturing, and commercialization. We anticipate the combined company will have the financial resources to fund our clinical programs to key value inflection points and we look forward to a successful future together."

CEO Shallcross concluded:

"We are excited to announce this transformative acquisition, as VCN's platform represents a potentially breakthrough approach to cancer treatment with oncolytic viruses by allowing for systemic delivery, high selectivity and enhanced tumor access. In addition to triggering tumor cell death, these therapies have been shown to elicit a strong anti-tumor immune response. The results of the Phase 1 clinical trial in PDAC, a highly aggressive and lethal malignancy, are very encouraging with respect to tumor response and survival. Significantly, biopsies in these patients confirmed up regulation of tumor immune markers and induction of a robust antitumor immune response, including increased tumor infiltration by cytotoxic T-cells. These results suggest VCN-01 holds significant potential to increase the addressable market for checkpoint inhibitors and CAR-T therapies, as these therapies have historically been less effective immunologically against "cold" tumors like PDAC."

"Based on encouraging results of prior preclinical and clinical trials of VCN-01, we plan to initiate a controlled Phase 2 clinical trial of VCN-01 at multiple centers across the US and EU. There is a significant unmet need for a safe and effective therapy for patients with pancreatic cancer, a condition in which most people diagnosed do not survive more than a year following their initial diagnosis. Based on highly encouraging early clinical results, we also plan to conduct a registrational trial in pediatric patients with advanced Rb. Importantly, this is an underserved patient population and we believe VCN-01 holds tremendous promise to preserve the eyes of these patients, who are typically less than two years old at diagnosis. We believe these trials can be conducted relatively quickly and efficiently. At the same time, we are also evaluating investigator-sponsored studies combining VCN-01 with CAR-T therapies, as well as VCN-01 in other orphan indications such as glioblastoma. We look forward to providing additional details on the timing and design of these trials in the near future."

In my opinion, the timing for Synthetic Biologics' effort to diversify and strengthen its pipeline was perfect because $10B Grifols (GRFS) which is one of the largest plasma biotechs in the world is in the process of aggressively divesting non-core assets. I am certain that Grifols 10-year investment in VCN was many times greater to the upfront money it received from Synthetic Biologics, and the only hope to recover those funds is for VCN to meet the future $70.25M milestone payments.

More on VCN And Its Technology Platform, Competition, and Valuation

VCN's technology platform is designed to overcome critical challenges that restrict the development of the majority of OV therapies today. Unlike many OVs that can only be administered by direct intratumoral injection, VCN's OVs are designed for systemic intravenous administration to target primary as well as metastatic tumors. Once inside the tumor, VCN's OVs are designed to replicate selectively and aggressively, and to produce hyaluronidase (PH20), an enzyme that digests hyaluronan, a key component of the dense tumor stroma that often plays a crucial role in tumor progression. Degradation of tumor stroma has been shown to diminish a significant physical and immunosuppressive barrier to cancer treatment and thereby improve access to the tumor by additional therapies such as chemo and immuno-therapies. Results from previously completed clinical trials demonstrate that this process can occur for weeks or months following a single intravenous injection with a VCN OV. VCN is seeking to leverage these unique capabilities to address cancers with a high unmet need.

VCN OVs are also designed to be administered intratumorally or intravitreally (in the eye), either as a monotherapy or in combination with standard of care, to treat a wide variety of cancer indications. Combination treatment of VCN OVs with a variety of chemotherapies and immunotherapies such as checkpoint inhibitors and CAR-T cells are in early clinical testing or planned. 

VCN’s proprietary PH20 hyaluronidase expression technology is at the core of its oncolytic virus pipeline, including VCN-01. PH20 hyaluronidase breaks down hyaluronan, a component of the tumor extracellular matrix. In desmoplastic tumors, such as pancreatic cancer, this hyaluronan-rich matrix blocks the perfusion of anticancer therapeutics. The hyaluronidase expression technology thus enables unique tumor remodeling properties that improve intratumoral viral spreading, immune system infiltration, and tumor uptake of drugs. Importantly, the expression of PH20 requires an actively replicating virus; nontumor cells that may be infected with VCN-01 do not allow viral replication nor PH20 expression.

Furthermore, the resulting adenovirus candidates also exhibit a range of beneficial properties, including the possibility of systemic administration, incorporation of a variety of expression cassettes, and a good toxicity profile. This allows for the administration of extremely high doses of the virus, which disperse through the bloodstream toward the body’s different metastatic sites. Once the virus reaches and infects the tumor cell, its highly cytopathic nature enables the efficient generation of tumor neoantigens that can boost the innate immune response (Fig. 1).

Unlike other companies in the fast-moving viral oncolytic field that have developed products to express immune-stimulatory transgenes, VCN believes its adenoviruses naturally contain sufficient immune-stimulatory elements, and that the expression of hyaluronidase by its candidates and remodeling of the matrix are crucial to the induction of effective immune responses.

Figure 1. The following slide depicts VCN-01 mode of action (MOA) when it is administered intravenously:

VCN's lead drug candidate, VCN-01, has been evaluated in four Phase 1 clinical trials to date, including in patients with pancreatic cancer, head and neck squamous cell carcinoma, and retinoblastoma (Rb). In a Phase 1 clinical trial, patients with metastatic pancreatic ductal adenocarcinoma (PDAC) received the combination therapy of intravenous VCN-01 with the standard of care chemotherapy Gemcitabine plus Abraxane® (G/A). Best results were observed when VCN-01 was administered one week before the first G/A dose. VCN-01 was well tolerated and when combined with G/A demonstrated an improved median overall and progression free survival, as well as a high response rate compared to G/A alone. These data compare favorably with current standard of care and are the basis of a planned Phase 2 clinical trial of the higher dosing level.

VCN-01 is also being studied as a monotherapy in patients with retinoblastoma (RB) who previously failed chemotherapy. Intravitreal administration of VCN-01 produced a complete remission and a reduction of tumors in several patients. These promising outcomes form the basis for an Orphan Drug application with the FDA and are planned to be explored in a larger future clinical trial.

VCN is also developing a next generation Albumin Shield™ technology platform, VCN-11, which builds upon the pre-clinical and clinical results of VCN-01. VCN-11 incorporates an albumin binding domain in the virus outer shell designed to enable the virus to coat itself with host serum albumin, potentially preventing its inactivation by neutralizing antibodies in the bloodstream en route to the tumor. The addition of the Albumin Shield technology is not expected to interfere with VCN-11's ability to target tumor cells and may allow for repeated administration to optimize tumor exposure.

The following slide extracted from VCN's website shows the company's diverse and growing pipeline:

Compare VCN's pipeline to that of Oncorus (NASDAQ:OTC:ONCR) which is developing cancer therapies in the same space (extracted from Oncorus November 2021 corporate presentation):

ONCR went public in late 2020 and at some point commanded a billion dollar market cap reaching $35/share in early 2021. However, its market cap has suffered significantly and it currently sits at $140M after reporting mediocre early results of its lead indication in November, 2021. Nevertheless, ONCR enjoys a loyal and strong institutional support with over 80% ownership according to Fintel.

Without being an IPO expert, I can clearly see that if VCN did  an IPO it would command an initial higher valuation than ONCR because of the more advanced pipeline and stronger clinical results thus far. This underscores the ridiculous $40M market cap for the entire SYN enterprise following the VCN acquisition. It is mind boggling that SYN's market cap is about 30% lower that the $65M cash in hand it will have after acquiring VCN. SYN's core technology and assets leverage the microbiome in a  effort to develop therapeutics designed to prevent and treat gastrointestinal diseases in areas of high unmet need. The Company’s lead candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (A) microbiome damage, (B) Clostridioides difficile infection (CDI), (C) overgrowth of pathogenic organisms, (D) the emergence of antimicrobial resistance (AMR) and (E) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. 

Once Mr. market realizes the significant upside being offered by SYN shares currently at 32c/share, the market cap will inevitably increase several-fold. The currently depressed value of SYN shares are due to a confluence of factors but more importantly because of the indiscriminate biotech rout that started in 2Q 2021, tax-selling season, and rampant manipulation. Rest assured that the January Effect could potentially provide fuel for a 500%+ gain in 1H 2022, and in particular after the VCN deal is consummated and following several expected milestones.

An analyst had a $2.5/share price target on SYN stock before the VCN acquisition. I expect that other analysts will jump on the SYN bandwagon in 2022 and beyond. But if you paid attention closely like I have, you would have noticed that just about every single day since the VCN deal was announced, large blocks traded right at the close of every regular-hour trading session. The last such block trade of over 500K shares was recorded on Friday, December 17, 2021. Who is doing this? opportunistic investors?, large institutions?, only time will tell.

As I stated before, the founding shareholders and other minority holders of 13.17% of VCN's capital will receive ordinary shares of Synthetic Biologics, which represent 19.99% of its total outstanding ordinary shares. This obviously means that they have significant vested interest and a strong desire to help SYN shares move up going forward.

VCN-01 leading the way in pancreatic cancer

I've extracted the following paragraphs from the article "Oncolytic adenovirus VCN-01 turns cold tumors hot," recently published in nature.com.

VCN-01, VCN’s lead candidate, is being developed to target a range of solid tumors, focusing initially on pancreatic cancer. Virus penetration within the tumor is improved through the expression of hyaluronidase by VCN-01, which simultaneously decreases intratumoral fluid pressure and facilitates the uptake of the chemotherapy or biologic drug. In addition, VCN’s capsid has been engineered to ensure the virus evades liver tropism and selectively targets the tumor once administered intravenously.

Clinical data from patients with pancreatic cancer demonstrated an extremely good safety profile, and also showed that VCN-01 induced CD8⁺T cell infiltration and activation of interferon-γ-mediated transcription, effectively converting a poorly immunogenic tumor into an inflamed tumor. In addition, in a subset of patients, the expression of programmed cell death 1/ programmed cell death 1 ligand 1 was upregulated. Additional data obtained to date in patients with pancreatic cancer have shown higher response rates and longer survival with VCN-01 than with the standard of care. More importantly, long-term survivors (more than 3.5 years) showed delayed significant responses that were indicative of immune-mediated activity.

To further confirm its antitumoral activity and to assess its potential, in addition to a trial investigating its use in combination with nab-paclitaxel and gemcitabine for pancreatic cancer, VCN-01 is currently being tested in combination with immune checkpoint inhibitors in metastatic squamous cell carcinoma of the head and neck refractory to checkpoint inhibitors. Results from these trials are expected soon.

Amazing VCN-01 Saves Child's Eye 

Although pancreatic and other well-known cancers are associated with VCN-01 preclinical and clinical trials, this one is a real story of the powerful flexibility wonder drug VCN-01 offers to address a wide range of cancer ailments.

A team of researchers from SJD Barcelona Children’s Hospital and the biotechnology company VCN Biosciences, a Grifols company, has developed a world-first treatment which has prevented a child, who had already lost an eye to retinal cancer, from losing the other eye and becoming completely blind.

As a result, Félix, who travelled from Venezuela to Barcelona specifically for the treatment, is now disease-free and retains his visual acuity, allowing him to walk and play just as before. The treatment, which was administered as part of a clinical trial, consists in injecting a genetically modified virus into the tumor-affected eye. This virus can select, attack and destroy cancer cells.

Félix was diagnosed with bilateral retinoblastoma (a cancer of the retina which affected both his eyes) when he was only a few months old. At two years old, having already lost one eye as a result of the disease, the boy travelled with his mother to Barcelona with the help of the Simón Bolivar Foundation to receive treatment at SJD Barcelona Children’s Hospital, which was able to save his other eye and his sight.

The medical team who treated him was able to deactivate the tumor using intra-arterial chemotherapy treatment. Eight months later, however, he had a relapse which meant he needed to return to Barcelona. It was then that the doctors at SJD Barcelona Children’s Hospital understood that the tumor was no longer responding to standard treatment and suggested that the boy participate in a clinical trial to assess the safety and efficacy of the VCN-01 oncolytic virus against chemotherapy-resistant retinal cancer.

The treatment Félix received is a derivative of the adenovirus -a common virus that normally causes cold symptoms, and which is now being used by some researchers to develop a vaccine for COVID-19- that has been modified in the VCN Biosciences laboratory to enable it to identify, infect and multiply inside cancer cells. This means that the virus can identify and selectively attack cancer cells while leaving healthy cells unharmed.

The development of this new retinal cancer treatment is the result of five years of research, and it highlights the importance of translational research (transferring knowledge from hospitals to laboratories and vice versa) which takes place at SJD Barcelona Children’s Hospital. A year ago, this research made the front page of the prestigious journal Science Translational Medicine, and received one of the most prestigious paediatric oncology awards in the world, the Odile Schweisguth prize.

Félix’s situation has shown the therapeutic effectiveness of the VCN-01 oncolytic virus in this indication for the first time, but more patients are required in the clinical trial in order to confirm whether the administered dose is the most suitable to ensure effectiveness. Candidates for participation in the study are children who have retinoblastoma which has not responded to standard treatments.

Addressable Markets

According to a 2019 market research report by ResearchAndMarkets, the global market for solid tumor treatment was an estimated $121 billion in 2018 and is expected to reach $424 billion by 2027. This represents a forecast CAGR (Compound Annual Growth Rate) of 15.0% from 2019 to 2027.

Key elements driving this expected growth are the growing incidence of breast cancer and other types of solid tumors as well as increasing awareness and treatment options being developed worldwide.

Also, North America currently accounts for 33.6% of market share, the highest by any region, while Europe trails at 30.2% and the Asia Pacific region represents 19.5% of demand. The Asia Pacific region is expected to grow at a high rate in the coming years due to increased income, developing healthcare infrastructure and increasing government programs for awareness.

Major competitive vendors that provide or are developing treatments include Amgen (AMGN), Ziopharm Oncology (ZIOP), BioNTech (NTGN), Gritstone Oncology (GRTS), Moderna Therapeutics (MRNA), Replimune, Merck (MRK), AstraZeneca (AZN), Johnson & Johnson (JNJ), PsiOxus Therapeutics, Regeneron (REGN), Vyriad, Turnstone Therapeutics, and others.

Upcoming Milestones

During the November 3, 2021 3Q 2021 conference call CEO Shallcross stated:

"...going forward, we expect to execute on a number of key milestones related to our current therapeutic pipeline that we believe will drive significant value for our shareholders. In addition, our strong balance sheet has enabled us to actively evaluate a variety of strategic options which could include potentially acquiring or licensing new therapies that could complement and further enhance our current pipeline (done with the VCN acquisition). We look forward to providing updates on our progress."

"In terms of some of the near-term milestones (existing pipeline):"

"First we anticipate reporting data from the first antibiotic cohort of the SYN-004 Phase 1a/2b clinical trial during the first quarter of 2022."

"Second, we look forward to reporting the data readout from our ongoing Phase 1 multiple ascending dose clinical trial of SYN-020 during the second quarter of 2022."

I expect more catalysts coming from VCN's preclinical and clinical activity in 1H 2022. VCN is not shy about attending major conferences including ASCO as seen by the News section of its website.

The following slide shows the current pipeline pre-VCN acquisition (source: December 2021 Corporate Presentation):

As seen in the above slide, prior to the VCN acquisition, the company was advancing a couple of drug candidates in its pipeline in several indications alone and in conjunction with major medical institutions. As stated above, Synthetic Biologics aims to leverage the microbiome to develop therapeutics designed to prevent and treat gastrointestinal diseases in areas of high unmet need.  

The first is SYN-004 or ribaxamase. This compound is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the GI tract to prevent microbiome damage. SYN-004 is an oral tablet meant to be co-administered with IV beta-lactam antibiotics. This combination is designed to prevent several afflictions including acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant [HCT] recipients and Clostridioides difficile infection or CDI. CDI affects some 450,000 Americans a year and causes just under 30,000 deaths annually. Estimates of in-hospital cost for allogeneic HCT recipients in the US range from $180,000 to more than $300,000, according to company management.

The company is working with the University of Washington to screen patients for a Phase 1b/2a clinical program to evaluation SYN004 for allogenic HCT recipients. This study will have three sequential cohorts with initial top-line results scheduled to be out sometime in the fourth quarter of this year. As for CDI, the company had an end of Phase 2 trial meeting with the FDA and believes that a single Phase 3 clinical trial maybe sufficient for approval for the prevention of antibiotic-mediated CDI. 

The company has several other compounds in very early stage development. The most advance of these is SYN-020. This is a recombinant version of bovine Intestinal Alkaline Phosphatase (IAP) an endogenous enzyme expressed in the upper small intestine. Preclinical studies have shown several benefits including reduction of inflammation and to promoting recovery of the gut microbiome after damage by antibiotics or other interventions. IAP has been very expensive to manufacture. Synthetic believes it's able to generate a high yield production cell line that at commercial scale is anticipated to enable cost effective manufacturing and greatly reduce the cost per gram of producing IAP.

Maxim Group Thinks Synthetic Biologics’ Stock is Going to Recover

In a report released on December 15, 2021, Jason McCarthy from Maxim Group maintained a Buy rating on Synthetic Biologics with a price target of $1.50.

Conclusions

• Synthetic Biologics scored a major coup in my opinion when it acquired novel oncology concern VCN Biosciences at the time when owner Grifols was unloading non-core assets. The upfront $4.7M the company spent to acquire a rich, growing, and diverse oncology pipeline is virtually nothing when compared to the recent initial $500M 2020 IPO of lesser competitor Oncorus which working on the same space and having a more abbreviated and less advanced pipeline. If VCN Biosciences were to do an IPO today it would certainly fetch something in the neighborhood of $500M. Sometimes it is better to be lucky than good, in this case Synthetic Biologics was both, and the extensive over-a-year due diligence CEO Shallcross mentioned in a recent conference call will return handsome profits to those who are buying at the current 33c. But investors must be patient to improve the chances of larger returns. 2022 will be very busy for the combines company with potentially half a dozen catalysts just in 1H 2022.
• Unlike other companies in the fast-moving viral oncolytic field that have developed products to express immune-stimulatory transgenes, VCN believes its adenoviruses naturally contain sufficient immune-stimulatory elements, and that the expression of hyaluronidase by its candidates and remodeling of the matrix are crucial to the induction of effective immune responses.
• The VCN deal includes an additional $70.25M of payments contingent upon the achievement of future milestones, a majority of which are tied to late-stage clinical development and regulatory achievements.
• Importantly, the founding shareholders and other minority holders of 13.17% of VCN's capital will receive ordinary shares of Synthetic Biologics, which represent 19.99% of its total outstanding ordinary shares. This obviously means that they have significant vested interest and a strong desire to help SYN shares move up going forward.
• VCN was founded by internationally recognized experts in oncolytic adenoviruses for cancer treatment. VCN's novel therapies allow for a robust and efficient manufacturing process, with an attractive cost structure. The platform is supported by a growing intellectual property (IP) portfolio that provides it patent protection through at least 2030 with additional patents underway that will further strengthen the company's IP portfolio.
• Importantly, VCN-01 has been granted Orphan Drug Designation by the European Medicines Agency (EMA), which may provide a number of benefits including up to ten years of market exclusivity.
• Following the VCN acquisition the company still has about at least $65M in cash which will provide significant runway to both support the company's existing programs, as well as to able to advance VCN-01 and VCN-011 through important milestones that will certainly drive significant shareholder value.
• Prior to the VCN acquisition, the company was advancing a couple of drug candidates in its pipeline aiming to leverage the microbiome to develop therapeutics designed to prevent and treat gastrointestinal diseases in areas of high unmet need.
• Regarding its existing pipeline, the company plans on reporting data from the first antibiotic cohort of the SYN-004 Phase 1a/2b clinical trial during the first quarter of 2022.
• The company also plans on reporting a data readout from its ongoing Phase 1 multiple ascending dose clinical trial of SYN-020 during the second quarter of 2022.
• SYN-004, administered orally, has been formulated to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the GI tract to prevent microbiome damage.
• SYN-020 is a recombinant version of bovine Intestinal Alkaline Phosphatase (IAP) an endogenous enzyme expressed in the upper small intestine.  Preclinical studies have shown several benefits including reduction of inflammation and to promoting recovery of the gut microbiome after damage by antibiotics or other interventions.
• Once the VCN Biosciences is consummated, the combined pipeline will show that the company is advancing 14 clinical and preclinical programs in various indications of great unmet needs. Such a pipeline usually would command a market cap at least in the half billion range. This is over 10 times the current market cap.
• In a report released on December 15, 2021, Jason McCarthy from Maxim Group maintained a Buy rating on Synthetic Biologics with a price target of $1.50. I expect that other analysts will join in and start covering the stock once VCN starts reporting clinical data in 1H 2022 and unleashes its planned clinical trial program.
• I fully expect a 500%+ gain with respect to the current share price during 1H 20212. 
• I recommend to investors interested in this opportunity to review all the risks and uncertainties discussed in the company's filings with the SEC.