A semi-thorough DD on $GOSS - 03-10-2021
Ticker: GOSS
Company Name: Gossamer Bio Inc.
Trading @ 10.67
CNN Money Analysts Link: https://money.cnn.com/quote/forecast/forecast.html?symb=GOSS
Price Target: $12 - $29
Pipeline:
- Seralutinib (GB002): Inhaled PDGFR, CSF1R, c-KIT inhibitor; Phase 2 ongoing
-What is it? GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
- Condition: Pulmonary Arterial Hypertension
- Description: The primary objective for this trial is to determine the effect of GB002 on improving pulmonary hemodynamics in subjects with the World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trials to determine the effect of GB002 on improving exercise capacity in this population.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04456998
2. GB004 - Ulcerative Colitis: Oral HIF-1a stabilizer; Phase 2 ongoing
- What is it? A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
- Condition: Ulcerative Colitis
- Description: A randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of 2 dose regimens of GB004 in adult subjects with mild-to-moderate active UC and who have disease activity despite treatment with 5-aminosalicylate (5-ASA). The primary objective of this study is to evaluate the effect of GB004 compared to placebo on clinical remission.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04556383
Latest news: GB004 Phase 1b Data Presentation at UEGW Virtual 2020
3. GB1275 - Solid Tumors: Oral CD11b modulator; Phase1/2 ongoing
- What is it? GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma
- Condition: Pancreatic Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma ,Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Triple Negative Breast Cancer, Castration-resistant Prostate Cancer, and Microsatellite Stable Colorectal Cancer
- Description: This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified Metastatic Solid Tumors
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04060342
4. GB001 - Asthma: Oral DP2 antagonist; Phase 2b completed
- What is it? GB001 in Adult Subjects With Moderate to Severe Asthma
- Condition: Asthma
- Description: A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03683576
Latest news: GB001 Potently Inhibits PGD2 Metabolite-Induced DP2-Mediated Cell Signaling and Eosinophil Activation
5. Discovery Programs: Multiple Preclinical Programs - not much information available except that these programs exist on their official pipeline on the website.
Other news: Gossamer Bio to Host Webcast Focused on its Inflammatory Bowel Disease Program, GB004, on February 18, 2021
Thoughts: I believe the pipeline is fairly populated with the latest news coming out in the second last quarter of 2020, this means that they are progressing positively towards their next goals which are to complete the development and release them. However, I believe it is important to note that this is a long term hold. Please refer to my post about entry and exit to better prepare yourself for this type of investment.
From 10-Q: Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities, and access to our Credit Facility, will be sufficient to fund our operations into the second half of 2023. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain.
Obligatory, this is not an investment advise of any kind. You are responsible for your own money and actions.
WARNINGS:
Our future capital requirements will depend on many factors, including:
1. the type, number, scope, progress, expansions, results, costs and timing of, our preclinical studies and clinical trials of our product candidates which we are pursuing or may choose to pursue in the future;
2. the costs and timing of manufacturing for our product candidates;
3. the costs, timing and outcome of regulatory review of our product candidates;
3. the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
4. our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;
5. the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase;
6. the timing and amount of the milestone or other payments we must make to the licensors and other third parties from whom we have in-licensed our acquired our product candidates;
7. the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved;
8. our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
9. the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements;
10. costs associated with any products or technologies that we may in-license or acquire; and
11. any delays and cost increases that result from the COVID-19 pandemic.
Until such time as we can generate substantial product revenues to support our cost structure, if ever, we expect to finance our cash needs through equity offerings, our Credit Facility, debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements.
However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, licenses and other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional capital when needed, we could be forced to delay, limit, reduce or terminate our product candidate development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Final Take: As I mentioned before, this is a long hold and I feel confident that it will reach it’s PT. I would highly advise you use a strategy to enter and exit… if you are unaware of this (for new investors) please view this blog post... In addition to this, I will be purchasing about $300 worth of shares at tomorrow's open (03/11/2021)
SEC Filings: https://ir.gossamerbio.com/financials/sec-filings
Reddit thread: https://www.reddit.com/r/EducatedInvesting/comments/lhbwvs/a_semithorough_dd_on_goss_03102021/
Comments
Post a Comment