Seeking Alpha • Sep 26

Gritstone bio: Early Data For SLATE Candidate Sets Up 2023 Catalyst

Summary Gritstone bio results from the phase 1/2 study, using SLATE vaccines in treating patients with KRAS mutant MSS-CRC and NSCLC, were positive with a 39% molecular response observed. Molecular response achieved in KRAS mutant NSCLC patients led to a doubling of overall survival; previous checkpoint inhibitor literature and another study using GRANITE proved this correlation. Updated results from the phase 1/2 study using SLATE vaccines for KRAS mutant MSS-CRC and NSCLC patients are expected in 2023. Additional Gritstone bio catalysts include data readouts from three phase 1 studies using CORAL for Covid-19 in 2nd half of 2022 and then GRANITE for MSS-CRC expected in the 2nd half of 2023. Gritstone bio, Inc. (GRTS) is a great speculative biotech play to look into. That's because it has already released early clinical data showing that its "off the shelf" SLATE candidate is capable of helping solid tumor patients. Especially, where it has moved from SLATE v1 (version 1) over to a more robust mutation targeting solid tumor treatment candidate known as SLATE-KRAS. It was able to achieve a 39% molecular response rate in both patients with late-stage microsatellite-stable colorectal cancer ((MSS-CRC)) and non-small cell lung cancer ((NSCLC)). While it may play out well for MSS-CRC, I was intrigued about what was shown in the NSCLC patient population. It was shown that for patients with NSCLC who achieved a molecular response, their overall survival ((OS)) number doubled. While observed only in a limited number of patients, this sets up long-term data which is expected to be released from this same study in 2023. I think this might be worth looking into, especially since the company wasn't afraid to apply a shift in strategy. When it saw that SLATEv1 wasn't performing well, it was able to shift over to SLATE-KRAS. Not only that, but I like that SLATE-KRAS (immunotherapy vaccine) can be combined with a PD-1 checkpoint blockade (Opdivo) and an anti-CTLA-4 antibody known as Yervoy. The ability to combine all these to achieve a molecular response, plus an excellent tolerability and safety profile is quite outstanding. Lastly, there is one more item to consider based on this SLATE vaccine, which is that the most recent data provides a pathway to target earlier lines of solid tumor patients. There are also many other catalysts for investors to look forward to over the next 18 months. Molecular Response Generates Substantial Improvement In Overall Survival In NSCLC Patients As I stated above, the most recent data is based on the SLATE-vaccines targeting solid tumor patients with mutations. The results are based on a phase 1/2 study which used SLATE v1 and SLATE-KRAS along with PD-1 checkpoint blockade Opdivo and an anti-CTLA antibody known as Yervoy, to treat both of these patient populations. Both of these KRAS vaccines were targeting patients with late-line microsatellite-stable colorectal cancer ((MSS-CRC)) and non-small cell lung cancer ((NSCLC)). It was noted that both of these vaccines generated a 39% molecular response rate in these specific evaluable patients. What exactly does molecular response mean? In essence the ability to reduce circulating tumor DNA ((ctDNA)) from baseline. The lower the ctDNA, the greater the molecular response rate. Where I believe this biotech has a good chance at moving forward with is specifically targeting NSCLC patients with KRAS mutations. That's not to say it won't still advance the SLATE vaccines against MSS-CRC, but it observed an impressive correlation. What correlation did it observe and why was it to impressive? It was shown that NSCLC patients who took SLATE vaccines, who achieved a molecular response, saw a doubling in their overall survival rate. This can be portrayed as follows: NSCLC patients who achieved a molecular response - achieved a median overall survival of 9.6 months NSCLC patients who didn't achieve a molecular response - achieved a median overall survival of 4.5 months. As you can see, the biomarker of molecular response predicted a greater outcome for these KRAS-mutant NSCLC patients. The two scenarios above prove that from these 18 NSCLC patients who achieved a molecular response, they saw a marked improvement in overall survival. However, updated data later on could also prove such an outcome in the colorectal cancer ((CRC)) patients. Why is that? Well, such a correlation of molecular response and OS could not be done for this patient population because there weren't enough evaluable patients then. What I would watch for in the next data update is to see if such a molecular response correlation happens for these CRC patients as well. I would also like to note that such a molecular response correlation is not just observed here on a whim. It has been observed in recent publications with checkpoint inhibitors. In addition, Gritstone has proved this same exact correlation with the GRANITE immunotherapy study in patients with advanced CRC. Therefore, with scientific literature making note of molecular response signifying major improvement in overall survival, along with it being observed in two studies by this company, I don't see how this effect can be a mere anomaly. I highlighted above that it is quite astonishing that SLATE vaccines were combined with Opdivo and Yervoy to achieve this efficacy, yet treatment was highly tolerated. It was shown that the majority of treatment-related adverse events were Grade 1/2. There were about three ≥ Grade 3 events reported with SLATE v1 and no ≥ Grade 3 events reported with SLATE-KRAS. This point here highlights that not only does SLATE-KRAS provide far more substantial efficacy compared to SLATE v1, but that it is also safer to administer to these KRAS tumor associated MSS-CRC/NSCLC patients. Not Afraid To Alter Strategy Got Them To Reach SLATE-KRAS Vaccine The data noted above, achieved in the phase 1/2 study, was done with both SLATE v1 and SLATE-KRAS. However, as I described above, SLATE-KRAS is likely going to be the better option moving forward towards other studies in these KRAS mutant tumor patients. Especially, since this positive data provides the rationale for moving towards treating patients with earlier lines of therapy. In other words, these solid tumor patients who have not yet received prior therapies. That's another impressive factor to consider for the molecular responses, along with the improvement OS observed in KRAS mutant NSCLC patients, in that these were patients who took and progressed on prior therapies already. The ability to allow SLATE-KRAS to start working earlier on, when the patient doesn't have advanced cancer disease, may generate a greater response (possibly even an improvement in survival as well). Such an improvement remains to be seen. The point is that this data noted above allows such a move, as Gritstone Bio has stated it intends to explorer earlier lines of therapy for these patient populations. Why the move to SLATE-KRAS from SLATE v1? The company thought that if it incorporated the targeting of shared neoantigens from KRAS, TP53, Beta-catenin and BRAF genes it could improve upon efficacy. However, this wasn't the case as non-KRAS neoantigens could gain immunodominance over their counterparts of KRAS neoantigens, thus making them obsolete. That was counterintuitive and as such, SLATE-KRAS was born. SLATE-KRAS is impressive because of its ability to exclusively only go after KRAS neoantigens. Over the years, you may have heard of common KRAS mutations/therapy targets such as G12C, G12D, G12V and Q61H. I think it was great that Gritstone recognized the need to pivot in this situation. Such a change in strategy allowed it to generate the data it date from the phase 1/2 study. While not all patients received SLATE-KRAS (some received SLATE v1), positive efficacy was still observed across both patient populations with both neoantigen vaccines. Again, moving forward, I believe that SLATE-KRAS will be the vaccine to move forward with. This point is illustrated as follows: Induction of KRAS-specific CD8+ T-cells for those given SLATE-KRAS - 55% Induction o KRAS specific CD8+ T-cells for those given SLATE v1 - 31% This highlights that the pivot to SLATE-KRAS was a great move. The biotech recognized the need to pivot and it did so quickly. Additional results from the phase 1/2 study to be released in 2023 will shed more light on this SLATE vaccine program. As such, this is a major catalyst for investors to look forward to moving into next year. Financials According to the 10-Q SEC Filing, Gritstone Bio had cash, cash equivalents, marketable securities and restricted cash of $159.2 million as of June 30, 2022. Despite this amount of cash, I think that this biotech is worth a look because it was able to establish an $80 million credit facility with Hercules Capital Inc., and Silicon Valley Bank. Under the terms of the agreement, it obtained $20 million upon closing and then another $10 million available for drawdown by March 15, 2023. From there, it could receive the remaining $50 million as tranches all the way through June 15, 2024. This is significant, because over the next 18 months it will have many other catalysts to look forward to. Not only will there be an update on the phase 1/2 study using the SLATE vaccine targeting MSS-CRC and NSCLC, but there are many other data updates for investors to look forward to. For instance, there are three ongoing phase 1 studies using CORAL vaccine for Covid-19. Results from all three of these early-stage studies from the CORAL program are expected in the 2nd half of 2022. Besides SLATE vaccines being used for cancer, there is another neoantigen treatment being developed by this biotech known as GRANITE. This treatment is being explored in a phase 2/3 study in combination with immune checkpoint blockade for 1st-line maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer ((MSS-CRC)). Preliminary results from this specific study is another catalyst to look forward to and the expected release is set for 2nd half of 2023. The bottom-line is that this cash position should likely be enough for the expected catalysts. However, it will likely need to raise cash before the end of 2023 if the credit facility is not enough to cover costs. For the time being, it estimates that is has enough cash to last for at least the next 12 months from August of 2022. Therefore, it's possible it may need to raise cash by other means by at least Q1 of 2023, if it feels the Credit Facility it developed won't be enough. Risks To Business There are several risks that investors should be aware of before investing in this biotech. The biggest risk to consider for the near-term would be the ongoing CORAL program, which is being explored in three ongoing phase 1 studies. Results from all of these studies are expected to be readout in the 2nd half of 2022. While the hope is that it can advance this program forward, there is no guarantee that the efficacy results will warrant further exploration for CORAL. As such, it's possible that these studies could be terminated if the desired efficacy is not achieved, especially since there are so many Covid-19 vaccines/treatments out there already.

Seeking Alpha • Jul 05

Gritstone bio: Potential To Advance Colorectal Cancer Treatment

Microsatellite stable colorectal cancer patients who had a molecular response who took GRANITE combination exceeded mOS of 18 months and mOS has not yet been reached. The global market opportunity for colorectal cancer is expected to reach $18.5 billion by 2023. Results from the phase 2 study, using SLATE-KRAS, for the treatment of patients with colorectal cancer and non-small cell lung cancer are expected in the 2nd half of 2022. Gritstone bio had $186.8 million in cash as of March 31, 2022; Enough cash to fund its operations for at least the next 12 months. Gritstone bio, Inc. (GRTS) is a speculative biotech that should be on everyone's radar. That's because it is making great progress in using its individualized neoantigen vaccine candidate known as GRANITE, which is being used to treat various types of solid tumors. It noted in a phase 1/2 study that specific colorectal cancer patients given GRANITE in combination with Opdivo (PD-1 checkpoint inhibitor) and Yervoy (ipilimumab) have obtained an overall survival ((OS)) advantage. Specifically, this was observed in a subset of patients who obtained a molecular response. Having said that, this is a great program because there are several other studies which are being initiated. This phase 1/2 I just noted had colorectal cancer patients who took 2 prior lines of therapy. The goal is to target these very same patients who are newly diagnosed or earlier lines of therapy. In addition, there is a catalyst for investors to look forward to. This will be results from the phase 2 study using SLATE-KRAS for the treatment of patients with non-small cell lung cancer ((NSCLC)) and colorectal cancer ((CRC)) in the 2nd half of 2022. GRANITE Combination Is Promising For Patients With Colorectal Cancer An advanced program in the pipeline is the use of GRANITE, which is being developed for the treatment of patients with microsatellite stable ((MSS)) colorectal cancer. Colorectal cancer is, as the name suggests, a type of cancer of the colon or rectum. It is a part of the lower end of the digestive tract. In the early stages, the issue first starts up as noncancerous polyps. At this early stage point, patients experience no symptoms at all. However, patients must get screened by Doctors to see if these polyps come about. That's why it is said that people should get checked at the age of 50, but earlier for someone who is at more severe risk. Patients who are at the cancerous stage of colorectal cancer (colon cancer) will have several symptoms such as: Abdominal pain Diarrhea Constipation blood in the stool These are just some of the symptoms that are involved, there are plenty more. It is not only an unmet medical need, but it is a pretty good sized population as well, which I believe will be a good market opportunity. The global market opportunity for colorectal cancer is expected to reach $18.5 billion by 2023. It is expected that there are more than 200,000 U.S. cases per year. The thing is that it is important to also understand the different between Microsatellite stable colorectal cancer (MSS CRC) and Microsatellite instable-High (MSI-H) colorectal cancer. In MSI-H, there is a mismatch/repair DNA problem that exists, and the immune system is easily attracted to this type. It is said that there are about 15% of patients who have MSI-High colorectal cancer. On the other hand, with MSS colorectal cancer, it doesn't have the DNA repair issues associated with the other type. It is said that about 85% of the entire colorectal cancer population has this type. That's the good news, however, with MSS CRC the tumors are "cold." They don't attract the immune system, thus it is as not easy as a target indication. Why I think that Gritstone has huge potential is that it has a specific avenue to target or subset of patients who are likely to respond to GRANITE treatment. In essence, I think the biotech can do well if it targets/treats those who do have a molecular response. Was this proven? It definitely was proven, as I noted at the beginning above, from the ESMO 2021 medical conference. This was shown in a phase 1/2 study which used GRANITE plus Opdivo and Yervoy for the treatment of patients with solid tumors. A total of 26 patients with solid tumors were recruited. Such solid tumors that these patients had were as follows: Gastroesophageal adenocarcinoma Non-small cell lung cancer Colorectal cancer The focus of Gritstone bio for the purpose of the ESMO 2021 presentation was to make note of the MSS CRC patients. It was noted that out of 9 patients with MSS CRC, this was the breakdown of molecular response: 4 patients with molecular response 5 patients with no molecular response Why do I bring this up exactly? That's because there is one major finding to note, which I think could eventually lead to a possible approval pathway. It noted that the 4 patients who had a molecular response had and continue to have a huge overall survival ((OS)) advantage, compared to those who didn't have a molecular response. The patients who didn't have a molecular response obtained a median OS of 7.8 months. This is what you would typically see for such MSS CRC patients who have taken 2 prior therapies. On the other hand, the 4 patients who had a molecular response exceed a mOS of 18 months and the mOS had not yet been reached. The point I'm trying to make here is that Gritstone holds potential to specifically target biomarker patients who have a molecular response. On the one hand, while this does switch the focus to a subset of patients, it also puts the focus on patients who are likely to have great benefit from GRANITE treatment. Having a mOS that exceeds 18 months is huge, when such a finding is unheard of for MSS CRC patients who have already taken 2 prior therapies. Expansion Opportunity For GRANITE Exists The thing is that it is quite great that the GRANITE combination was able to get such a strong mOS number in those who had a molecular response. What would also be possible is to improve this number even further when exploring the use of this treatment in prior lines of therapy. As such, Gritstone is expanding the use of it in two other studies. In January of 2022 the phase 2/3 GRANITE-CRC-1L was initiated. This particular study is using GRANITE in combination with immune checkpoint blockade (like PD-1) for the treatment of newly diagnosed patients with metastatic, MSS CRC. Preliminary results from this study are expected in the 2nd half of 2023. The other study to further explore GRANITE for CRC was initiated in March of 2022. This phase 2 study is known as GRANITE-CRC-ADJUVANT and is recruiting high risk MSS-CRC patients who are circulating tumor DNA (ctDNA)+ after surgery. The bottom line here is that if GRANITE worked well for the 3rd line patient population (specifically those with molecular response) then it's possible it could work even better for earlier lines of therapy (1st line/2nd line). Financials According to the 10-Q SEC Filing, Gritstone bio had cash, cash equivalents, marketable securities and restricted cash of $186.8 million as of March 31, 2022. A big reason for the cash on hand was that back in September of 2021 it announced a $55 million private investment in public equity ((PIPE)) financing from the sale of 5,000,000 shares of its common stock at a price of $11 per share. This PIPE was led by Frazier Life Sciences Public Fund, with additional participation by Redmile Group and Gilead Sciences (GILD). In October of 2019 it made a 2019 Shelf Registration Statement, which covered up to $250 million of various equity and debt securities, including the issuance of up to $75 million worth of shares of its common stock under the 2019 ATM Offering Program. Through March 31, 2022, it received net proceeds of its 2019 ATM Offering Program of $50 million.

CEO maaş yüzdesi	n/a
CEO görev süresi	3.8yrs
CEO sahipliği	0.06%
Yönetim ortalama görev süresi	3.8yrs
Yönetim Kurulu ortalama görev süresi	6yrs

İsim	Pozisyon	Görev süresi	Tazminat	Sahiplik
Vassiliki Economides	Interim Chief Executive Officer and Chief Financial Officer	3.8yrs	Veri yok	0.056% $ 0.08
James Cho	Chief Accounting Officer	4.3yrs	Veri yok	0.056% $ 0.08
Stacy Proctor	Executive VP & Chief People Officer	3.8yrs	Veri yok	Veri yok

İsim	Pozisyon	Görev süresi	Tazminat	Sahiplik
Elaine Jones	Independent Chairman of the Board	5.6yrs	US$176.00k	Veri yok
Stephen Webster	Independent Director	1yr	Veri yok	0.017% $ 0.02
Lawrence Corey	Independent Director	2.7yrs	US$132.50k	Veri yok
Timothy Chan	Member of Scientific Advisory Board	7.8yrs	Veri yok	Veri yok
Eugene Zhukovsky	Member of Scientific Advisory Board	6yrs	Veri yok	Veri yok
Graham Lord	Member of Scientific Advisory Board	7.8yrs	Veri yok	Veri yok
Naiyer Rizvi	Independent Director & Member of Scientific Advisory Board	8.8yrs	US$140.00k	Veri yok
James Gulley	Member of Scientific Advisory Board	7.8yrs	Veri yok	Veri yok
Alessandro Sette	Member of Scientific Advisory Board	7.8yrs	Veri yok	Veri yok
Shefali Agarwal	Independent Director	3.8yrs	US$138.50k	Veri yok
Clare Fisher	Independent Director	3.3yrs	US$136.50k	Veri yok

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2025/04/07 23:09
Gün Sonu Hisse Fiyatı	2025/04/03 00:00
Kazançlar	2024/06/30
Yıllık Kazançlar	2023/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Madhu Kumar	Baird
Douglas Buchanan	Citizens JMP Securities, LLC
Corinne Johnson	Goldman Sachs

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Gritstone bio Yönetim

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Gritstone Bio, Inc. Announces CEO Changes

Gritstone Bio, Inc. Announces Resignation of Executives

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Gritstone bio, Inc., Annual General Meeting, Jun 17, 2024

Gritstone Bio, Inc. Announces Board Changes

Less than half of directors are independent

Recent updates

Gritstone Bio Files Form 15

Gritstone Bio, Inc. Announces CEO Changes

Gritstone Bio, Inc. Announces Resignation of Executives

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Motion for Asset Sale Filed by Gritstone bio, Inc.

Gritstone bio, Inc.(OTCPK:GRTS.Q) dropped from NASDAQ Composite Index

New major risk - Revenue and earnings growth

Gritstone bio Receives Delisting Notice from Nasdaq Due to Chapter 11 Case and it Does Not Intend to Appeal the Determination

New major risk - Market cap size

New major risk - Share price stability

Gritstone Bio Announces Interim Phase 2 Data for Granite Individualized Neoantigen Targeting Immunotherapy in Frontline Metastatic Microsatellite Stable Colorectal Cancer

Consensus revenue estimates decrease by 60%, EPS upgraded

Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind

Gritstone Bio, Inc. Receives Non-Compliance Notice Regarding Minimum Bid Price Requirement

We Think Some Shareholders May Hesitate To Increase Gritstone bio, Inc.'s (NASDAQ:GRTS) CEO Compensation

Price target decreased by 16% to US$4.33

New major risk - Revenue and earnings growth

First quarter 2024 earnings released: US$0.34 loss per share (vs US$0.30 loss in 1Q 2023)

Gritstone bio, Inc. to Report Q1, 2024 Results on May 09, 2024

Gritstone bio, Inc., Annual General Meeting, Jun 17, 2024

Gritstone Bio, Inc. Announces Board Changes

Consensus revenue estimates decrease by 17%, EPS upgraded

Nature Medicine Publishes Interim Results from Gritstone Bio's Phase 1/2 Study of "Off-The-Shelf" Neoantigen Vaccine Platform (SLATE)

New minor risk - Market cap size

Gritstone bio: GRANITE Cancer Vaccine Data Overshadowed By Offering

Gritstone bio, Inc. has completed a Follow-on Equity Offering in the amount of $32.5 million.

Gritstone Bio, Inc. Announces Positive Preliminary Progression-Free Survival and Long-Term Circulating Tumor DNA (ctDNA) Data from Phase 2/3 Study of its Personalized Cancer Vaccine, Granite, Granite, Granite

Consensus revenue estimates decrease by 37%

New major risk - Revenue and earnings growth

Full year 2023 earnings: EPS and revenues exceed analyst expectations

New major risk - Share price stability

Price target decreased by 12% to US$8.80

Gritstone Bio Announces Update to Comparative Phase 2B Covid-19 Clinical Trial

Consensus revenue estimates fall by 40%

Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind

Gritstone Bio, Inc. Announces Presentation of Results from Three Ongoing Phase 1 Studies Evaluating Its Self-Amplifying Mrna (Samrna) Vaccine Candidates Against Covid-19 (Part of the Company’s Coral Program) at IDWeek 2023

Price target increased by 20% to US$10.34

Gritstone bio, Inc. (NASDAQ:GRTS) Analysts Just Slashed This Year's Revenue Estimates By 40%

Price target increased by 20% to US$10.34

Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind

New major risk - Financial position

Consensus revenue estimates fall by 53%

Price target decreased by 14% to US$8.60

First quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind

Gritstone bio, Inc. to Report Q1, 2023 Results on May 11, 2023

Full year 2022 earnings: EPS and revenues exceed analyst expectations

Price target decreased to US$8.75

Price target decreased to US$10.00

Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

Price target decreased to US$10.00

Gritstone bio: Early Data For SLATE Candidate Sets Up 2023 Catalyst

Gritstone reaches six-month high on publication of data for cancer vaccine

Consensus revenue estimates increase by 14%

Price target increased to US$16.00

Second quarter 2022 earnings: EPS and revenues exceed analyst expectations

Gritstone bio announces $80M credit facility

Is Gritstone bio (NASDAQ:GRTS) In A Good Position To Invest In Growth?

Gritstone bio: Potential To Advance Colorectal Cancer Treatment

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Price target increased to US$16.00

Consensus forecasts updated

First quarter 2022 earnings: EPS and revenues exceed analyst expectations

Price target decreased to US$14.67

Less than half of directors are independent

Some Analysts Just Cut Their Gritstone bio, Inc. (NASDAQ:GRTS) Estimates

Consensus revenue estimates fall by 57%

Full year 2021 earnings: EPS misses analyst expectations

We're Not Very Worried About Gritstone bio's (NASDAQ:GRTS) Cash Burn Rate