Replies to post #18 on Tocagen Inc (TOCA)

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gr8db8
Thanks for the link. I like the science here........

Tocagen to Report First Quarter 2018 Financial Results on Thursday, May 10
Thu May 3, 2018 4:05 PM|PR Newswire|About: TOCA
SAN DIEGO, May 3, 2018 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today announced it will report its first quarter 2018 financial results and business progress on Thursday, May 10, 2018, after the close of the U.S. financial markets.

https://mma.prnewswire.com/media/524567/Tocagen_Logo.jpg

To receive Tocagen's press releases and other investor information, please visit the Investor Relations page of the company's website and register for email alerts.

About Tocagen (TOCA)
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. For more information about Tocagen, visit www.tocagen.com.

Media Contact:
Monica May
Canale Communications
[phone]
[e-mail]

Investor Contact:
Gitanjali Jain Ogawa
Solebury Trout
[phone]
[e-mail]

[stockguard]

You might like the read in this article with follow up Q&A if you have not it yet had a chance to see it........

Reader Inquiry: Tocagen Is Looking Cheap But Is It A Buy?
May 6, 2018 12:03 AM ET|12 comments | About: Tocagen Inc (TOCA)
Jonathan Faison
https://seekingalpha.com/article/4170313-reader-inquiry-tocagen-looking-cheap-buy
Long only, biotech, event-driven
MARKETPLACEROTY
Summary
Recent reversal in the stock price has investors concerned.

We take a look at recent developments as well as previous data.

Contributors to the decline include a potential ¨catalyst desert¨ and possible dilution in the medium term.

Despite receiving both Breakthrough Therapy and PRIME designations, when cash is backed out the valuation looks quite cheap.

While admittedly high risk, I greatly admire what they are seeking to accomplish, will be keeping tabs on the firm and reevaluate later in the year.

This idea was discussed in more depth with members of my private investing community, ROTY .

Shares of Tocagen (TOCA) have declined by over 40% in the past year. While the stock rose by as much as 45% after my article in late October, the reversal has been quite sickening to watch and can´t be attributed to weakness in the biotech sector alone.

Chart
Figure 1: TOCA daily advanced chart (source: Finviz)


Figure 2: TOCA 15 minute advanced chart (source: Finviz)

When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels and get a feel for what is going on. In the first chart (daily advanced) the selloff and sea of red since March sticks out like a sore thumb. In the second, we can see the stock has tried to bottom at the $9 level but the ensuing bounce has been short-lived. I wouldn't be surprised in the near term if it breaks support and heads lower.

Reader Inquiry
In the marketplace service ROTY (Runners of the Year), we search for stocks that are attractive across multiple time frames with high % upside potential within the near to medium term. Catalyst ideas typically have upcoming material events (such as clinical results reading out or regulatory action date) that could push shares significantly higher- on the other hand, revaluation ideas involve stocks where the core business (or core assets) and recent events have not been fully factored into the share price AND future appreciation is expected.


Figure 3: Wholly-owned pipeline (source: corporate presentation)

In the case of Tocagen, several ROTY members have been discussing the stock in Live Chat and I´ve received a few questions regarding future prospects. After the recent decline I agree it's a good time to take a second look to determine if there's more to this story that merits a position or if we root for them from the sidelines.

Recent Developments
There's been some news flow since the beginning of the year- in March the company announced that the European Medicines Agency granted orphan medicinal product designation to Toca 511 and Toca FC for the treatment of patients with glioma.

At the American Association for Cancer Research Annual Meeting the company presented early data (poster) from the Toca 6 phase 1 study in advanced solid tumors. As of the cutoff date of March 27th 7 patients had been treated with Toca 511 & Toca FC intravenously with 4 of these also receiving Toca 511 via intratumoral administration. Highlights included cancer-selective expression of the Toca 511 trasgene following IV administration in metastatic tumors of 5 patients who underwent tissue analysis (indicating successful delivery of the retroviral replicating vector), clearing of Toca 511 from blood plasma within 6 weeks (indicating virus is well controlled outside of tumors) and the solid safety profile observed thus far.

Many biotech companies have been inking China deals and Tocagen is not the exception- in April they entered into a license with ApolloBio to develop and commercialize Toca 511 & Toca FC within the greater China region. In return Tocagen received $16 million in cash upfront plus potential near term payments of $4 million. They also stand to receive up to $111 million in development and commercial milestones plus low double-digit tiered royalty payments based on net sales.

Other Information
For the fourth quarter the company reported cash and equivalents of $88.7 million (doesn't include funds received from China collaboration) and management has guided for cash used in operations to come in at or under $50 million. Net loss for the full year 2017 totaled $38.9 million.

It's quite confounding to consider that the company´s lead product candidate has received both the coveted Breakthrough Therapy Designation from the FDA and PRIority MEdicines designation from the EMA, and yet when cash is backed out the market believes it's worth less than $100 million.

As for upcoming catalysts of note, management is guiding for enrollment of the phase 3 Toca 5 study in recurrent high-grade glioma (NYSE:HGG) to finish up before the end of the year. We should also receive an update on the European regulatory pathway and management will outline their development plan for newly diagnosed HGG.

I remind readers that phase 1 results have shown survival significantly exceeding historical data at both the low and high doses.

Figure 4: Phase 1 resection study OS trend by dose (source: corporate presentation)

Importantly, Toca 511 was associated with relatively low occurrence of treatment-related adverse effects (trAE) and for Toca FC trAE were mainly in the grade 1 to 2 range. Impressively, at higher doses (n=23) durable response rate was 21.7% with all five patients experiencing complete responses (median duration of response not reached at 35 months and counting).

Figure 5: Long term survival in higher dose cohort (source: corporate presentation)

Final Thoughts
In the end, I believe this is definitely a story to keep tabs on as later in the year we receive updated data in solid tumors and enrollment hopefully finishes up for the pivotal Toca 5 study. While lead indications being targeted are high risk, I believe they have a good shot at success and that present weakness is more a function of what's known as a "catalyst desert" (where there is not much in the way of near-term material events). This could lead to continued downside in the near term, but late in 2018 Tocagen will merit a revisit for possible entry.

Considering their current cash position and burn rate, dilution in the medium term is possible. Delays in enrollment or other setbacks would likely pressure shares even futher, while disappointing results in the Toca 5 study would be devastating to the bullish thesis. Disapointing data in other trials such as Toca 6 would also weigh on shares.

While I won't be currently adding this one to the ROTY Contenders List, I imagine we will continue to discuss it especially after earnings in May are reported and we receive more guidance from management.

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[stockguard]

Wish I understood more about the science behind it all. What I do understand it will likely get to market as the results will be good.

Analyst Wangzhi highlights that TOCA is a Phase 3 clinical-stage biotech company developing novel viral gene therapy for cancer. It has developed a proprietary Retroviral Replicating Vector (RRV) platform to selectively deliver therapeutic genes in tumor cells. Lead program Toca 511 & Toca FC delivers cytosine deaminase to convert pro-drug 5-FC (5-fluorocytosine) to active 5-FU (5-Fluorouracil) selectively in tumor cells, which kills the tumor cells and also induces immune response.

Li views TOCA as an attractive investment opportunity with multiple upcoming catalysts and significant upside potential:
I. We see a good probability of success (POS) for Toca 511 & Toca FC pivotal trial with potential market launch in 2020 to address the high unmet need of rHGG ($1.2B+ market), given:

1. Toca 511 & Toca FC Phase 1 trials showed good safety and strong efficacy signal indicated by: 1) 5/23 (21.7%) pivotal trial eligible rHGG pts achieved rare durable CR (38.0+ to 57.5+ m) in rHGG with impressive mOS of 14.4m vs 6-10m of current TRx; 2) Late response onset and gradual improvement from PR to CR in 2 pts is consistent with the immune mechanism of action of Toca 511 & Toca FC; 3) Trend of dose response in OS; 4) Both FDA and EMA have granted Toca 511 & Toca FC BTD and PRIME designations after their diligent review of the Phase 1 results.

2. We see a good POS for the Toca5 pivotal trial to recapitulate the promising Phase 1 results in rHGG, based on: 1) Design of Toca5 pivotal trial recapitulates key Phase 1 signal with reasonable assumptions to provide decent buffer room for success; 2) Potential variables (injection procedures, resection extent and distribution of rGBM vs rAA pts, etc.) for Toca5 outcome appear to be in good control; 3) Strong regulatory support from FDA and EMA with BTD and PRIME designations; 4) Enrollment on track to complete by YE2018 with two interim analysis to provide earlier readouts in 2H18 and 1H19.

3. Toca 511 & Toca FC results appear highly competitive among products currently in active clinical development for rGBM/rHGG (page 15).

II. We see significant upside potential of expanding Toca 511 & Toca FC into other solid tumors.

III. We also see broad upside potential of expanding RRV platform to deliver a variety of anti-cancer viral gene therapy (e.g., local aPD-L1 by Toca 521).