Aankondiging • Feb 03
Mirati Therapeutics, Inc. Files Form 15 Mirati Therapeutics, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.001 per share. Aankondiging • Nov 12
Mirati Therapeutics, Inc. Receives Positive Opinion from CHMP for KRAZATI as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer with a KRASG12C Mutation Following a Re-Examination Procedure Mirati Therapeutics, Inc. announced that following a re- examination procedure, the Company has received a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on KRAZATI(R) (adagrasib) as a targeted treatment option for adult patients with KRAS(G12C) -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy. About KRAZATI® (adagrasib): Mirati has risen to meet one of the most challenging mutations in cancer research by developing KRAZATI, a highly selective and potent oral small-molecule inhibitor of KRASG12C. Intentionally designed to meet the challenge of KRASG12C, adagrasib is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours.1Adagrasib has shown clinically to be a CNS penetrant, which may be important given that CNS metastases frequently occur in NSCLC and lead to poor prognosis. The FDA provided KRAZATI Accelerated Approval (Subpart H), allowing for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints. KRAZATI was also granted a conditional marketing authorization by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) on November 3, 2023. About KRASG12C in NSCLC: Lung cancer is one of the most common cancers worldwide, accounting for 2.21 million new cases and 1.8 million deaths worldwide in 2020.5 Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.6 KRASG12C is the most common KRAS mutation in NSCLC, present in approximately 14% of patients with lung adenocarcinoma, and is a biomarker mutation of poor prognosis. Reported Earnings • Nov 07
Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2023 results: US$2.49 loss per share (improved from US$3.09 loss in 3Q 2022). Revenue: US$16.4m (up 202% from 3Q 2022). Net loss: US$161.9m (loss narrowed 6.7% from 3Q 2022). Revenue missed analyst estimates by 15%. Earnings per share (EPS) exceeded analyst estimates by 14%. Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 37% per year, which means it is performing significantly worse than earnings. Aankondiging • Oct 18
Mirati Therapeutics, Inc. Presents Late-Breaking Results Evaluating the Combination of Adagrasib and Pembrolizumab in First-Line Non-Small Cell Lung Cancer Mirati Therapeutics, Inc. announced updated results from the KRYSTAL-7 Phase 2 study evaluating adagrasib combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation at the European Society of Medical Oncology Congress (ESMO) 2023. These data demonstrate a manageable safety profile and early signs of durability of adagrasib in combination with a checkpoint inhibitor in the first-line NSCLC setting. Summary of Clinical Results: In patients with PD-L1 TPS =50%, adagrasib and pembrolizumab demonstrated an overall response rate (ORR) of 63% and disease control rate (DCR) of 84% and promising early signs of durability. The 63% confirmed response rate compares favorably to pembrolizumab monotherapy which has demonstrated an ORR of 39-45%. A median progression free survival has not been reached at 10.1 months median follow up. The safety profile of the adagrasib and pembrolizumab combination was consistent with either agent as monotherapy, with a low rate of treatment related adverse events (TRAEs) leading to discontinuation of both drugs in only 4% of patients. Treatment related hepatic events occurred in <10% of patients and were predominantly low grade. No patients discontinued both adagrasib and pembrolizumab due to ALT/AST increase or hepatic-related TRAEs. Mirati plans to initiate a Phase 3 clinical study to evaluate adagrasib in combination with pembrolizumab in the first line setting for KRASG12C-mutated NSCLC with PD-L1 TPS =50%. Initial patient enrollment is expected by year-end 2023. Aankondiging • Oct 10
Bristol-Myers Squibb Company (NYSE:BMY) entered into a definitive agreement to acquire Mirati Therapeutics, Inc. (NasdaqGS:MRTX) for $3.4 billion. Bristol-Myers Squibb Company (NYSE:BMY) entered into a definitive agreement to acquire Mirati Therapeutics, Inc. (NasdaqGS:MRTX) for $3.4 billion on October 8, 2023. Under the terms of the merger agreement, Bristol Myers Squibb through a subsidiary will acquire all of the outstanding shares of Mirati common stock at a price of $58.00 per share in cash representing a 52% premium to the 30-day VWAP as of the unaffected October 4, 2023 close, for a total equity value of $4.8 billion corresponding to an enterprise value of approximately $3.7 billion, which accounts for approximately $1.1 billion of Mirati cash. Each Mirati stockholder will also receive one non-tradeable CVR per Mirati share, which will entitle its holder to receive a one-time potential payment of $12.00 in cash, for a total value of approximately $1.0 billion, upon acceptance by U.S. FDA of a new drug application for MRTX1719. Bristol Myers Squibb expects to finance the acquisition with a combination of cash and debt. The transaction is subjected to Mirati's shareholders and regulatory approval. The transaction was unanimously approved by both the Bristol Myers Squibb and the Mirati Boards of Directors. The transaction is anticipated to close by the first half of 2024. Evercore Inc. acted as financial advisor to Bristol-Myers Squibb Company. Morgan Stanley & Co. LLC acted as financial advisor to Bristol-Myers Squibb Company. Jonathan L. Davis, Emily Lichtenheld, Daniel E. Wolf, Scott D. Price, Katherine C. Nemeth, Patricia A. Carson, Amber Harezlak, Sophia Hudson, Sara B. Zablotney and Vivek Ratnam of Kirkland & Ellis LLP acted as legal advisor to Bristol-Myers Squibb Company. Centerview Partners LLC acted as financial advisor to Mirati Therapeutics, Inc. Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor to Mirati Therapeutics, Inc. Price Target Changed • Oct 08
Price target increased by 9.7% to US$60.00 Up from US$54.69, the current price target is an average from 16 analysts. New target price is approximately in line with last closing price of US$60.20. Stock is down 10% over the past year. The company is forecast to post a net loss per share of US$11.93 next year compared to a net loss per share of US$13.18 last year. Aankondiging • Oct 06
Sanofi Reportedly Explores Potential Acquisition of Mirati Therapeutics French pharmaceutical giant Sanofi (ENXTPA:SAN) is exploring a potential acquisition of cancer drugmaker Mirati Therapeutics, Inc. (NasdaqGS:MRTX), according to people familiar with the matter. Mirati’s shares surged as much as 38% in New York trading. They were up 26% to $53.88 at 2:58 p.m., elevating the San Diego-based company’s market value to about $3.7 billion. Sanofi has been studying a deal for Mirati, the people said, asking not to be identified because the information is private. Deliberations are ongoing and there’s no certainty they will result in an agreement. Mirati could also attract interest from other suitors, the people said. A spokesperson for Mirati said that it doesn’t comment on market rumors or speculation. A representative for Sanofi also said it doesn’t comment on market rumors. A sale would give Mirati further resources to help it commercialize the treatment and fund further studies. Since August, the company’s Chief Executive and Chief Financial Officers have stepped down. Bloomberg News reported last year that it was drawing takeover interest from large pharmaceutical companies. New Risk • Oct 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (18% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$478m net loss in 3 years). Shareholders have been diluted in the past year (23% increase in shares outstanding). Aankondiging • Aug 24
Mirati Therapeutics, Inc. Announces CFO Changes Effective as of September 8, 2023 Mirati Therapeutics, Inc. announced that on August 17, 2023, Laurie Stelzer notified Mirati Therapeutics, Inc.(the “Company”) of her intention to resign from her position as the Company’s Chief Financial Officer and principal financial and accounting officer, effective as of September 8, 2023 (the “Separation Date”), in order to pursue an opportunity with another biotechnology company. Ms. Stelzer has agreed to provide transition consulting services (the “Consulting Services”) to the Company for an initial term of 60 days following the Separation Date. As consideration for providing the Consulting Services, the Company will pay Ms. Stelzer $10,000 per month and her outstanding equity awards will continue to vest pursuant to their terms.On August 21, 2023, the Board of Directors of the Company (the “Board”) appointed Aaron Ondrey, the Company’s Senior Vice President, Financial Planning and Analysis, as the Company’s Interim Chief Financial Officer and principal financial officer, effective as of the Separation Date. Mr. Ondrey, age 47, has served as the Company’s Senior Vice President, Financial Planning and Analysis since July 2022. Prior to joining the Company Mr. Ondrey served as Vice President, Finance of Arena Pharmaceuticals, Inc., a public biotechnology company (acquired by Pfizer Inc. in March 2022) from January 2020 until July 2022. From December 2018 to January 2020, Mr. Ondrey served as Head of Global Commercial Finance at Alexion Pharmaceuticals, Inc., a public biotechnology company (acquired by AstraZeneca in July 2021). From March 2010 to November 2018, Mr. Ondrey served in various finance roles of increasing responsibility, most recently as Executive Director, Commercial Finance and Business Planning, at Regeneron Pharmaceuticals, Inc., a public biotechnology company. Mr. Ondrey received his Bachelor of Science in Business Administration and Finance from Case Western Reserve University. Board Change • Aug 10
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Independent Director Julie Michele Cherrington was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Aug 10
Mirati Therapeutics, Inc. Publishes Preclinical and Initial Clinical Data for MRTX1719 to Treat MTAP-Deleted Cancers Through Novel Approach to MTA-Cooperative PRMT5 Inhibition Mirati Therapeutics, Inc. announced Cancer Discovery published preclinical and initial clinical data from a first-in-human Phase 1/2 clinical trial of MRTX1719, a PRMT5 /methylthioadenosine (MTA)-cooperative inhibitor evaluated in methylthioadenosine phosphorylase (MTAP) deleted cancers. These results provide preclinical and early clinical proof-of-concept for this differentiated approach and demonstrate that MRTX1719 may represent a promising targeted therapy for the ~10% of cancer patients with this biomarker. In preclinical studies, MRTX1719 was demonstrated to be a potent, selective inhibitor of the PRMT5/MTA complex. This compound exploits the elevated MTA levels present in MTAP-deleted cancers and turns this altered metabolic state into a therapeutic vulnerability to selectively kill MTAP deleted cancer cells while sparing normal cells. Preclinical results showed marked anti-tumor activity of MRTX1719, including regression, across lung, pancreatic, mesothelioma, and other solid tumor models. As of June 13, 2023, there were 18 patients with solid tumors harboring MTAP deletions in the Phase 1/2 trial of MRTX1719 that were evaluable for clinical response at dose levels of 100mg QD or greater. Initial dose level started at 50mg administered once-daily orally over 21-day cycles followed by 100% dose escalations for subsequent dose levels. Six individual case narratives were selected for inclusion in the Cancer Discovery publication: There were six confirmed objective responses observed in the Phase 1 study including one patient who achieved a response which subsequently confirmed post-data cutoff. MRTX1719 achieved apparent complete PRMT5 inhibition in MTAP deleted tumor cells at a dose of 200 mg QD as evidenced by pretreatment and on-treatment tumor biopsies of the PRMT5 biochemical biomarker symmetric dimethyl arginine (SDMA). It was notable that four patients were on therapy for multiple cycles before experiencing an initial objective response, with their tumors continuing to decrease in size over the course of treatment. These findings suggest that tumor response may continue to deepen over time indicating the importance of evaluating tumor response kinetics and response rates across a broader patient population with longer follow up. MRTX1719 was well-tolerated with no dose limiting toxicities observed at dose levels up to 400mg QD. None of the patients treated with MRTX1719 experienced dose-limiting adverse events associated with first generation PRMT5 inhibitors such as thrombocytopenia, anemia or neutropenia. MRTX1719, discovered at Mirati, is an orally bioavailable, methylthioadenosine (MTA)-cooperative PRMT5 inhibitor that exhibits synthetic lethality in MTAP-deleted cancers. MTAP deletion leads to MTA accumulation in cancer cells and MRTX1719 is designed to selectively bind the PRMT5-MTA complex ultimately inhibiting PRMT5 function in MTAP-deleted cancer cells while sparing healthy non-tumor cells.1MTAP deletions occur in around 10% of all cancers2, including a high percentage of pancreatic cancer, non-small cell lung cancer, and mesothelioma which are associated with a poor prognosis, representing a significant unmet medical need. The PRMT5-MTA complex creates a novel drug target for the treatment of MTAP-deleted cancers. Targeting this complex involves a new and potentially improved therapeutic approach. MRTX1719 is being evaluated as monotherapy and in combination with other therapeutic options to treat patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene. Reported Earnings • Aug 09
Second quarter 2023 earnings: EPS exceeds analyst expectations Second quarter 2023 results: US$3.04 loss per share. Revenue: US$13.7m (up 155% from 2Q 2022). Net loss: US$176.9m (flat on 2Q 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 5.2%. Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Aankondiging • Jul 26
Mirati Therapeutics, Inc. to Report Q2, 2023 Results on Aug 08, 2023 Mirati Therapeutics, Inc. announced that they will report Q2, 2023 results on Aug 08, 2023 Aankondiging • Jul 23
Mirati Therapeutics Provides Update on Regulatory Review in the European Union of Krazati (Adagrasib) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) with A Krasg12c Mutation Mirati Therapeutics, Inc. announced the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the Conditional Marketing Authorisation Application (MAA) for KRAZATI® (adagrasib) for treatment of patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC). Mirati disagrees with the opinion and intends to request a formal re-examination. CHMP states that KRAZATI has a positive risk-benefit profile, however, does not fulfill certain requirements for a Conditional Marketing Authorisation. Mirati believes KRAZATI addresses the Conditional Marketing Authorisation requirements despite there being a currently conditionally approved KRASG12C inhibitor and that KRAZATI possesses a differentiated clinical profile. Key differentiators include KRAZATI’s efficacy profile, potential central nervous system activity and combinability with other agents, including concurrent with or following treatment with an immune checkpoint inhibitor. The MAA for KRAZATI was based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg administered orally twice daily in 116 patients with KRASG12C-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor. Mirati is supplying KRAZATI to eligible European patients with a KRASG12C mutation based on individual requests from healthcare professionals. Mirati intends to continue supplying KRAZATI under early access in EU Member States in alignment with applicable laws and regulations. This decision will have no impact on any of Mirati’s clinical trials. Study enrollment for KRYSTAL-12, the confirmatory Phase 3 trial evaluating adagrasib versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRASG12C mutation, is progressing as expected. Progression-free survival and interim overall survival results are anticipated in the first half of 2024. Price Target Changed • Jul 23
Price target decreased by 8.0% to US$60.64 Down from US$65.93, the current price target is an average from 14 analysts. New target price is 94% above last closing price of US$31.31. Stock is down 54% over the past year. The company is forecast to post a net loss per share of US$12.52 next year compared to a net loss per share of US$13.18 last year. New Risk • Jul 16
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$200k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$483m net loss in 3 years). Shareholders have been diluted in the past year (4.8% increase in shares outstanding). Significant insider selling over the past 3 months (US$200k sold). Aankondiging • Jun 24
Mirati Therapeutics Appoints Carol Gallagher, Pharm.D. as New Independent Director Mirati Therapeutics, Inc. announced its Board of Directors has appointed a new independent director, Dr. Carol Gallagher. Dr. Gallagher has over 30 years of strategic, commercial, business development and drug development leadership experience in the life sciences industry. Currently, Dr. Gallagher serves as a venture advisor at New Enterprise Associates (NEA), a global venture capital firm. She has also served as a partner with Frazier Healthcare. Previously, Dr. Gallagher was CEO of Calistoga Pharmaceuticals, where she led the company through its acquisition by Gilead Sciences in 2011. Dr. Gallagher has held leadership roles with Eli Lilly, Amgen, Agouron Pharmaceuticals, Pfizer, Idec Pharmaceutics, CancerVax and Anadys Pharmaceuticals. A veteran board director, Dr. Gallagher currently serves as a board member of PMV Pharma, Atara Biotherapeutics and, until its recent acquisition by Bristol Myers Squibb in August 2022, Turning Point Therapeutics. Dr. Gallagher attended Vanderbilt University and holds Bachelor of Science and Doctor of Pharmacy degrees from the University of Kentucky. She also serves as a Trustee on the Board of Trustees for the Salk Institute. Recent Insider Transactions • Jun 04
Chief Financial Officer recently sold US$172k worth of stock On the 2nd of June, Laurie Stelzer sold around 5k shares on-market at roughly US$37.06 per share. This transaction amounted to 5.5% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Laurie's only on-market trade for the last 12 months. Aankondiging • May 25
Mirati Therapeutics Provides Update on the Phase 3 SAPPHIRE Study Evaluating Sitravatinib in Combination with OPDIVO(R) Mirati Therapeutics, Inc. announced that the SAPPHIRE study did not meet its primary endpoint of overall survival at the final analysis. SAPPHIRE is a Phase 3 study evaluating sitravatinib in combination with nivolumab (OPDIVO(R) versus docetaxel in patients with second or third line advanced non-squamous non-small cell lung cancer (NSQ-NSCLC) who progressed on prior therapy with chemotherapy and immune checkpoint inhibitor therapy. The company plans to disclose the study data at a future date. Principal Investigators will be given the option to continue therapy for patients who are experiencing clinical benefit and would like to remain on treatment. Board Change • May 18
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 9 experienced directors. 2 highly experienced directors. CEO & Director David Meek was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Major Estimate Revision • May 16
Consensus revenue estimates increase by 23% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$54.3m to US$66.9m. Forecast losses expected to reduce from -US$13.73 to -US$12.78 per share. Biotechs industry in the US expected to see average net income decline 85% next year. Consensus price target broadly unchanged at US$69.80. Share price rose 6.6% to US$49.44 over the past week. Major Estimate Revision • Mar 07
Consensus revenue estimates decrease by 28% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$74.0m to US$53.5m. EPS estimate unchanged at -US$13.78 per share. Biotechs industry in the US expected to see average net income decline 42% next year. Consensus price target broadly unchanged at US$70.73. Share price fell 10% to US$41.59 over the past week. Aankondiging • Feb 15
Mirati Therapeutics, Inc. to Report Q4, 2022 Results on Feb 28, 2023 Mirati Therapeutics, Inc. announced that they will report Q4, 2022 results at 4:00 PM, US Eastern Standard Time on Feb 28, 2023 Recent Insider Transactions • Jan 20
CEO & Director recently sold US$135k worth of stock On the 17th of January, David Meek sold around 3k shares on-market at roughly US$42.38 per share. This transaction amounted to 20% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$367k. David has been a net seller over the last 12 months, reducing personal holdings by US$321k. Aankondiging • Jan 20
Mirati Therapeutics, Inc. Announces U.S. Food and Drug Administration Clears the Investigational New Drug (Ind) Application of MRTX1133 Mirati Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of MRTX1133, a potential first-in-class oral KRASG12D selective inhibitor for clinical evaluation. KRASG12D mutations impact approximately 180,000 patients in the US and Europe, representing approximately a 2.5-fold increase in prevalence compared to KRASG12C mutations. No targeted oncology treatment options currently exist for these patients. MRTX1133 is a highly potent investigational inhibitor of the KRASG12D driver mutation and demonstrated selective and reversible inhibition of KRASG12D in both its active and inactive states. In addition, MRTX1133 administration resulted in marked tumor response in preclinical KRASG12D mutated pancreatic cancer models as well as lung and colorectal cancer models. MRTX1133 has demonstrated favorable properties including a low risk for off-target activity and drug interactions and a predicted human half-life of greater than 50 hours. The Phase 1/2 clinical trial will launch in early 2023 with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other KRASG12D tumor types. MRTX1133 is an investigational, highly potent, selective and reversible small molecule inhibitor of KRASG12D that is optimized to sustain near complete target inhibition with the potential to be both a first and best-in-class treatment option. MRTX1133 is entering Phase 1 clinical evaluation in 2023 investigating the drug's impact on KRASG12D-driven cancers. Recent Insider Transactions • Jan 09
Founder recently sold US$170k worth of stock On the 4th of January, Charles Baum sold around 4k shares on-market at roughly US$46.60 per share. This transaction amounted to 4.2% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger sale worth US$367k. Charles has been a net seller over the last 12 months, reducing personal holdings by US$537k. Recent Insider Transactions • Dec 23
Executive VP & Chief Scientific Officer recently sold US$104k worth of stock On the 16th of December, James Christensen sold around 2k shares on-market at roughly US$43.00 per share. This transaction amounted to 5.4% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger sale worth US$156k. Insiders have been net sellers, collectively disposing of US$1.8m more than they bought in the last 12 months. Price Target Changed • Dec 09
Price target decreased to US$91.40 Down from US$115, the current price target is an average from 15 analysts. New target price is 108% above last closing price of US$43.85. Stock is down 68% over the past year. The company is forecast to post a net loss per share of US$13.37 next year compared to a net loss per share of US$11.21 last year. Recent Insider Transactions • Dec 08
Executive VP & Chief Scientific Officer recently sold US$156k worth of stock On the 2nd of December, James Christensen sold around 2k shares on-market at roughly US$90.19 per share. This transaction amounted to 4.5% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$1.7m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Dec 01
Founder exercised options and sold US$5.7m worth of stock On the 28th of November, Charles Baum exercised 69k options at a strike price of around US$17.41 and sold these shares for an average price of US$100.00 per share. This trade did not impact their existing holding. Since December 2021, Charles' direct individual holding has increased from 55.62k shares to 67.61k. Company insiders have collectively sold US$15m more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • Nov 16
Consensus revenue estimates increase by 48% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$9.71m to US$14.4m. Forecast losses expected to reduce from -US$13.85 to -US$13.37 per share. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target broadly unchanged at US$115. Share price rose 17% to US$72.33 over the past week. Seeking Alpha • Sep 08
Mirati: A Potential Blockbuster Stock, Will Need Patience Summary
Mirati has strong competitive differences against larger rival Amgen.
However, lead indication, 2nd line NSCLC, is not where these differences will come out.
Investors need to be patient and wait for combo data, 1st line NSCLC and especially CRC for Mirati to really stand out.
I have been regularly covering Mirati Therapeutics, Inc. (MRTX) for nearly a year now. The stock has been on a steady downward movement throughout, and has only plateaued around June from the earlier spiral. Indeed, since my last cautious coverage, the stock is up 35%.
One key reason for Mirati’s price movement is Amgen’s (AMGN) recent data from lumakras, which has again showed Mirati's superior data for adagrasib. For people in the know, to cover Mirati and not to mention lumakras is ludicrous. The adagrasib-lumakras story is thoroughly intertwined. You need to understand lumakras in order to get the Mirati story.
Mirati competes with Amgen in the KRAS G12C mutant NSCLC space. In 2nd line NSCLC, Adagrasib may have a slight edge over lumakras in efficacy, however lumakras may have an edge - also slight - in safety; plus it is ahead in clinical development, having been approved on an accelerated basis, and it has a higher median duration of response to boot. Adagrasib’s slight edge lies in the slightly higher ORR, and signs of improvement in patients with brain metastases; as well as in patients with a specific co-mutation which is known to have poor prognosis. Another important point is that adagrasib works well in combination with other drugs. For example, adagrasib has very superior data in frontline NSCLC in combination with keytruda. Lumakras' data here is much poorer.
As I said about these two points before:
Another angle with adagrasib is its CNS penetration. Mice data has shown that adagrasib has a much better brain concentration than AstraZeneca’s Tagrisso. The company is enrolling a cohort of patients to assess adagrasib in NSCLC patients with a G12C mutation and active brain metastases.
Also, KRAS and STK11 co-mutations comprise approximately 30% of KRASG12C mutant NSCLC. A potentially registration enabling Phase 2 monotherapy study in 1st line NSCLC patients with STK11 co-mutation was initiated in Q1:2021. About this program, the company said:
Patients with STK11 co-mutations or TTS scores of less than 1% have a poor prognosis with standard of care therapies with objective response rates in the first-line of approximately 30% and median progression-free survival of less than 6 months. In patients with STK11 co-mutations, published real-world data suggests that the medium progression-free survival is approximately 2 months. Collectively, these 2 patient sub-groups represent greater than 40% of the total first-line KRAS G12C non-small cell lung cancer patient population. We are discussing the potential registration pathways for each of these patient populations with the FDA.
It is also the only molecule in its class with a ~24 hour half life. Lumakras (Sotorasib) has a half life of 5.5 hours.
While this was about NSCLC, where adagrasib has some competition from lumakras, I have said before that in CRC, adagrasib’s data is beyond compare. Unfortunately for Mirati investors, the company’s lead indication right now is 2nd line NSCLC. Therefore, the market may believe Mirati is playing catch up with Amgen. This isn’t true for CRC. While lumakras has had just a 7% response rate in CRC, Mirati showed a 22% response rate and a median duration of response ((MDOR)) of 4.2 months. As the company has previously guided, anything better than 20% and 4 months respectively is good enough for seeking accelerated approval. Recently at ESMO 2022, Mirati again showed its superiority both as a monotherapy and as a combo in CRC versus lumakras - see here.
In 2nd line NSCLC, though, while Amgen managed to push in a very late breaking abstract from its CODEBREAK-200 confirmatory trial, the data readout pushed up MRTX stock because it throws some doubt on lumakras’ full approval based on this data alone. Recent Insider Transactions Derivative • Aug 18
Independent Director notifies of intention to sell stock Bruce Leonard Carter intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of August. If the sale is conducted around the recent share price of US$80.45, it would amount to US$805k. Since March 2022, Bruce Leonard has owned 2.00k shares directly. Company insiders have collectively sold US$9.3m more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • Aug 10
Consensus revenue estimates increase by 15% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$8.21m to US$9.46m. Forecast losses expected to reduce from -US$14.41 to -US$14.06 per share. Biotechs industry in the US expected to see average net income decline 47% next year. Consensus price target up from US$114 to US$119. Share price rose 16% to US$83.05 over the past week.