Tillkännagivande • Feb 05
Rain Oncology Files Form 15 Rain Oncology 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 par value $0.001 per share. Tillkännagivande • Dec 15
Pathos AI, Inc. entered into a definitive merger agreement to acquire Rain Oncology Inc. (NasdaqGS:RAIN) for $42.2 million. Pathos AI, Inc. entered into a definitive merger agreement to acquire Rain Oncology Inc. (NasdaqGS:RAIN) for $42.2 million on December 13, 2023. Pathos AI will acquire Rain for $1.16 in cash per share plus a non-tradeable contingent value right (a “CVR”) for potential cash payments of up to approximately $0.17 per share. Pursuant and subject to the terms of the merger agreement, a subsidiary of Pathos will commence a tender offer to acquire all outstanding shares of Rain. Post acquisition, Rain will operate as a separate, wholly-owned subsidiary of Pathos.
The closing of the tender offer is subject to certain conditions, including the tender of Rain shares representing at least one share more than 50% of the total number of outstanding shares of common stock as of immediately prior to consummation of the tender offer; the availability of at least $49.6 million of cash and cash equivalents, net certain liabilities at closing; and other customary conditions. The stockholders holding approximately 44.0% of the outstanding shares of Rain common stock have entered into support agreements with Pathos pursuant to which they have agreed to tender their shares in the tender offer. The Rain Board of Directors voted unanimously to approve the proposed Offer. If the tender offer is successful, the transaction is expected to close in January 2024. Leerink Partners is acting as exclusive financial advisor and Ryan A. Murr, Branden C. Berns, Chris Trester and Robert Phillips of Gibson, Dunn & Crutcher LLP are acting as legal counsel to Rain. Mitchell S. Bloom, Robert Masella, Jean A. Lee of Goodwin Procter LLP are acting as legal counsel to Pathos. New Risk • Nov 10
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.6% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$24m net loss in 3 years). Shareholders have been diluted in the past year (3.6% increase in shares outstanding). Market cap is less than US$100m (US$37.3m market cap). Price Target Changed • Nov 10
Price target decreased by 69% to US$1.44 Down from US$4.65, the current price target is an average from 4 analysts. New target price is 40% above last closing price of US$1.03. The company is forecast to post a net loss per share of US$1.63 next year compared to a net loss per share of US$2.71 last year. Price Target Changed • Sep 05
Price target decreased by 30% to US$4.65 Down from US$6.61, the current price target is an average from 5 analysts. New target price is 365% above last closing price of US$1.00. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$1.65 next year compared to a net loss per share of US$2.71 last year. Tillkännagivande • Aug 17
Rain Oncology Inc., Proterra Inc., Bioxcel Therapeutics, Inc Announces Class Action Update Johnson Fistel, LLP, a law firm specializing in shareholder rights, has announced the initiation of class action lawsuits on behalf of investors of the following companies. Investors are encouraged to review the deadlines listed and submit their information. Class Period: July 20, 2021 and May 19, 2023. Lead Plaintiff Deadline: September 12, 2023. The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the Company concealed risks inherent in the design of its Phase 3 MANTRA study particularly with regard to proceeding directly to Phase 3 from Phase 1; (2) as a result, the Company’s statements about the trial and the likelihood of FDA approval were materially misleading during the Class Period, and (3) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.The lawsuit alleges Proterra made materially false and/or misleading statements and/or failed to disclose material adverse facts, including: (i) Proterra repeatedly stated the $523 million of cash on its balance sheet meant Proterra had abundant liquidity and financial stability; and (ii) Proterra’s new Greer, South Carolina factory would continue to improve production efficiency and gross margins. BioXcel Therapeutics, Inc. (NASDAQ: BTAI). Class Period: December 15, 2021 and June 28, 2023; Lead Plaintiff Deadline: September 5, 2023; The BioXcel class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) BioXcel lacked adequate internal controls over protocol adherence and data integrity; (ii) as a result, BioXcel’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (iii) BioXcel’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the U.S. Food and Drug Administration (“FDA”); (iv) BioXcel’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; and (v) the above would negatively impact BioXcel’s ability to obtain regulatory approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease. A lead plaintiff will act on behalf of all other class members in directing the class-action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the class-action lawsuit. An investor's ability to share any potential future recovery of the class action lawsuit is not dependent upon serving as lead plaintiff. Tillkännagivande • Jul 28
Rain Oncology Inc. to Report Q2, 2023 Results on Aug 10, 2023 Rain Oncology Inc. announced that they will report Q2, 2023 results at 4:00 PM, US Eastern Standard Time on Aug 10, 2023 Tillkännagivande • Jul 15
Levi & Korsinsky, LLP Files a Complaint to Recover Losses Suffered by Purchasers of Rain Oncology Inc. Securities Levi & Korsinsky, LLP filed a complaint to recover losses suffered by purchasers of Rain Oncology Inc. securities. On May 22, 2023, the Company announced that milademetan failed to meet its primary endpoint of progression free survival in the MANTRA study. Moreover, the Company announced adverse event findings that, according to analysts, indicated that the dosing schedule had not been optimized prior to commencing the study. In response to the announcement, Rain’s stock price substantially dropped from $9.93 per share to $1.22 per share, eliminating approximately $316 million in market capitalization in one day. The complaint alleges that defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company concealed risks inherent in the design of its Phase 3 MANTRA study particularly with regard to proceeding directly to Phase 3 from Phase 1; and, (ii) as a result, the Company’s statements about the trial and the likelihood of FDA approval were materially misleading during the Class Period. Price Target Changed • May 24
Price target decreased by 59% to US$7.46 Down from US$18.00, the current price target is an average from 6 analysts. New target price is 501% above last closing price of US$1.24. Stock is down 46% over the past year. The company is forecast to post a net loss per share of US$2.02 next year compared to a net loss per share of US$2.71 last year. Tillkännagivande • May 23
Rain Oncology Inc. Announces Topline Results from Phase 3 MANTRA Trial of Milademetan for Treatment of Dedifferentiated Liposarcoma Rain Oncology Inc. announced its topline pivotal Phase 3 MANTRA data. The trial, evaluating the efficacy, safety, and tolerability of milademetan in patients with dedifferentiated (DD) liposarcoma (LPS), did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review compared to the standard of care, trabectedin. The median PFS for milademetan was 3.6 months vs 2.2 months for trabectedin, with a hazard ratio of 0.89, p=0.53. The most common treatment emergent adverse events (TEAEs) in the milademetan arm included nausea, thrombocytopenia, anemia, vomiting and neutropenia. The most common Grade 3/4 TEAEs were thrombocytopenia (39.5%), neutropenia (25.5%) and anemia (18.6%). Dose reductions in the milademetan arm were 44.2% vs 29.1% in the trabectedin arm. Discontinuation in the milademetan arm due to AEs were 11.6% vs 19.0% for trabectedin. Based upon these topline data, Rain does not expect to pursue further development of milademetan in DD LPS. Rain hopes to present the MANTRA data in an upcoming medical conference. Phase 3 MANTRA Topline Data Results: The median PFS was 3.6 months with milademetan versus 2.2 months for trabectedin, with a hazard ratio of 0.89 (95% CI [0.61 to 1.29]; p=0.53) based on 115 events. Most common TEAEs in the milademetan arm included nausea, thrombocytopenia, anemia, vomiting and neutropenia. The most common Grade 3/4 TEAEs in the milademetan arm were thrombocytopenia (39.5%), neutropenia (25.5%) and anemia (18.6%). Dose reductions in the milademetan arm were 44.2% vs 29.1% in the trabectedin arm. Discontinuations in the milademetan arm due to AEs were 11.6% vs 19.0% for trabectedin. Treatment emergent SAEs in the milademetan arm were 36.0% vs 48.1% in the trabectedin arm. Price Target Changed • Mar 10
Price target increased by 7.4% to US$19.44 Up from US$18.11, the current price target is an average from 9 analysts. New target price is 116% above last closing price of US$8.99. Stock is up 34% over the past year. The company is forecast to post a net loss per share of US$2.42 next year compared to a net loss per share of US$2.65 last year. Tillkännagivande • Jan 24
Rain Oncology Inc. Announces Phase 1 Clinical Data of Milademetan Publishes in Journal of Clinical Oncology Rain Oncology Inc. announced the publication of a peer-reviewed article titled, “A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients with Advanced Liposarcoma, Solid Tumors or Lymphomas” in the Journal of Clinical Oncology. Phase 1 clinical data in the paper highlight the activity and tolerability using intermittent dosing of milademetan across a range of tumor types including dedifferentiated liposarcoma (DD LPS), which represented the proportion of patients enrolled in the study (n=53). All liposarcoma patients enrolled in the Phase 1 trial exhibited the DD LPS subtype; Among DD LPS patients in the Phase 1 trial, median progression-free survival (mPFS) outcomes were maintained with intermittent dosing schedules (once daily [qd] on days 1-3 and 15-17 every 28 days; eg, 3/14 days) compared with extended (qd on days 1-21) /continuous (qd on days 1-28) schedules: mPFS of patients across all doses/schedules (n=53): 7.2 months; mPFS of patients with 260 mg qd 3/14 intermittent schedule (n=16): 7.4 months; mPFS of previously treated patients with 260 mg qd 3/14 intermittent schedule (n=11): 8.0 months; mPFS of treatment-naïve patients in all doses/schedules (n=17): 14.6 months. Although all tested DD LPS patients had MDM2 gene amplification (n=22), mPFS in DD LPS patients did not differ by levels of key biomarkers including MDM2 or CDK4 copy number or by mRNA expression levels of MDM2, CDK4, or MDM4. Preliminary single-agent activity with milademetan in DD LPS prompted the ongoing, randomized Phase 3 MANTRA trial (NCT04979442), with topline data anticipated in the first quarter of 2023. Recent Insider Transactions Derivative • Jan 13
Senior VP & Head of Research notifies of intention to sell stock Vijaya Tirunagaru intends to sell 21k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of January. If the sale is conducted around the recent share price of US$8.66, it would amount to US$181k. As of today, Vijaya currently holds no shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively bought US$1.1m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Nov 25
lead Independent Director recently bought US$988k worth of stock On the 22nd of November, Franklin Berger bought around 122k shares on-market at roughly US$8.10 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$1.0m more in shares than they have sold in the last 12 months. Tillkännagivande • Nov 05
Rain Therapeutics Provides Interim Analysis of Phase 2 Basket Trial of Milademetan for Mdm2-Amplified Advanced Solid Tumors Rain Therapeutics Inc. announced preliminary data in the multicenter, single arm, open-label, Phase 2 basket trial evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of MDM2-amplified advanced solid tumors. The MANTRA-2 trial is designed to evaluate the safety and efficacy of milademetan monotherapy in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy and that exhibit wild-type p53 and a prespecified minimum MDM2 gene copy number. Approximately 65 patients are anticipated to be enrolled to receive milademetan. As of the latest data cutoff on October 26, 2022, 17 patients have been enrolled. The primary endpoint of the trial is objective response rate as measured by RECIST criteria. Secondary endpoints include duration of response, disease control rate progression-free survival by investigator assessment, overall survival and growth modulation index. As of the latest data cutoff on October 26, 2022, 17 patients have been enrolled, 15 of whom have been dosed with milademetan Ten patients were efficacy-evaluable with CN =8 by central testing A diverse set of tumor histologies were enrolled amongst the evaluable patients Most tumors had co-alterations in oncogenes or tumor suppressors, including KRAS, EGFR, and PIK3CA amongst others Two unconfirmed PRs were observed with tumor regression of 34% and 30% (pancreatic and lung cancer, respectively) The patient with pancreatic cancer is pending response confirmation and ongoing treatment The patient with lung cancer is deceased due to COVID-19 Two patients exhibited promising activity with tumor regression of 29% and 27% (biliary tract and breast cancer, respectively) and the patients are continuing with the investigational therapy Observed anti-tumor effect of milademetan in heavily pretreated, refractory patients, with a median of four prior therapies Safety profile to date is preliminarily consistent with prior Phase 1 trial of milademetan. Milademetan (also known as RAIN-32) is an oral small molecule inhibitor of the MDM2-p53 complex that reactivates p53. Milademetan has demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supported by a rationally designed dosing schedule to mitigate safety concerns and widen the potential therapeutic window of MDM2 inhibition. Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS, and is evaluating milademetan in a Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2). Rain anticipates commencing a Phase 1/2 clinical trial to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche’s atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors (MANTRA-4), in the first quarter of 2023. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LPS. Tillkännagivande • Oct 28
Rain Therapeutics Inc. to Report Q3, 2022 Results on Nov 10, 2022 Rain Therapeutics Inc. announced that they will report Q3, 2022 results on Nov 10, 2022 Price Target Changed • Sep 13
Price target decreased to US$18.00 Down from US$20.80, the current price target is an average from 6 analysts. New target price is 183% above last closing price of US$6.35. Stock is down 61% over the past year. The company is forecast to post a net loss per share of US$2.65 next year compared to a net loss per share of US$2.65 last year. Tillkännagivande • Aug 05
Rain Therapeutics Inc. Announces Completion of Enrollment in Phase 3 MANTRA Trial for Milademetan in Liposarcoma Rain Therapeutics Inc. announced completion of enrollment in its Phase 3 MANTRA randomized, global, registrational trial of its lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53. The trial targeted an enrollment of 160 patients and completed enrollment five months ahead of schedule with 175 patients. The MANTRA trial is evaluating milademetan compared to an approved standard of care in patients with well- differentiated /dedifferentiated (WD/DD) liposarcoma (LPS) that have progressed on at least one prior systemic therapy including an anthracycline. MANTRA is an event-driven trial with progression-free survival (PFS) as the primary endpoint, which will be analyzed upon reaching 105 events. The MANTRA trial is powered to show a doubling of PFS versus the standard of care. Recent Insider Transactions • Jun 04
Co-Founder recently bought US$57k worth of stock On the 1st of June, Avanish Vellanki bought around 25k shares on-market at roughly US$2.29 per share. This was the largest purchase by an insider in the last 3 months. This was Avanish's only on-market trade for the last 12 months. Price Target Changed • Jun 03
Price target decreased to US$16.17 Down from US$20.80, the current price target is an average from 6 analysts. New target price is 499% above last closing price of US$2.70. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$2.55 next year compared to a net loss per share of US$2.65 last year. Price Target Changed • May 30
Price target decreased to US$18.00 Down from US$20.80, the current price target is an average from 5 analysts. New target price is 620% above last closing price of US$2.50. Stock is down 87% over the past year. The company is forecast to post a net loss per share of US$2.55 next year compared to a net loss per share of US$2.65 last year. Recent Insider Transactions Derivative • Mar 15
Co-Founder notifies of intention to sell stock Avanish Vellanki intends to sell 46k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of March. If the sale is conducted around the recent share price of US$7.00, it would amount to US$324k. For the year to December 2020, Avanish's total compensation was 54% salary and 46% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2021, Avanish has owned 2.37m shares directly. Company insiders have collectively bought US$2.2m more than they sold, via options and on-market transactions, in the last 12 months. Tillkännagivande • Feb 09
Rain Therapeutics Inc. Announces the Appointments of Several Industry Veterans to the Leadership Team Rain Therapeutics Inc. announced the appointments of several industry veterans to the leadership team, including: Nora Ku, MD, Vice President of Clinical Development, joining from Loxo Oncology at Lilly; Buenaflor (Flor) Nicolas, MPH, Vice President, Head of Global Drug Safety and Pharmacovigilance, joining from Gilead Sciences Inc.; Tina Kim-Hafken, MS, Vice President and Head of Global Regulatory Affairs, joining from Seagen Inc.; and Steve Flint, SHRM, MBA, Vice President of People &Culture, joining from AltruBio Inc. Additionally, Rain announced that John Maraganore, Ph.D., former founding CEO of Alnylam and biotechnology industry veteran, has served as a Special Advisor to Rain's Chief Executive Officer (CEO), Avanish Vellanki, and the leadership team since March 2021. Ku served as Vice President of Medical at Loxo/Lilly. Previously, Dr. Ku was Consultant and Senior Medical Director at DAVA Oncology following several years in various practice settings as a clinical investigator. After earning her M.D. from the University of California Los Angeles (UCLA), Dr. Ku completed her internship and residency in internal medicine at the University of Texas, Southwestern Medical Center, and fellowship in hematology and medical oncology at UCLA. Recent Insider Transactions • Sep 24
Independent Director recently bought US$54k worth of stock On the 21st of September, Franklin Berger bought around 4k shares on-market at roughly US$14.30 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$2.2m more in shares than they have sold in the last 12 months. Tillkännagivande • Sep 09
Rain Therapeutics Inc. Presents Non-Clinical Data on Milademetan (RAIN-32) in Malignant Pleural Mesothelioma at the IASLC 2021 World Conference on Lung Cancer Rain Therapeutics Inc. announced non-clinical data on its oral mouse double minute 2 (MDM2) inhibitor, milademetan (RAIN-32), presented at the IASLC 2021 World Conference on Lung Cancer (#WCLC21) hosted by the International Association for the Study of Lung Cancer and held virtually September 8-14, 2021. Key findings from Rain’s poster presentation include: Milademetan treatment showed differential sensitivity in mesothelioma models with cyclin dependent kinase inhibitor 2A (CDKN2A) loss and wild-type p53 compared to p53 deficient models. Milademetan treatment increased p53 protein levels in the MDM2 inhibitor-sensitive cell lines, demonstrating target engagement and a p53-mediated mechanism of action. Oral milademetan significantly reduced the growth of multiple MDM2 inhibitor-sensitive MPM xenografts. Recent Insider Transactions • Apr 29
Independent Director recently bought US$2.1m worth of stock On the 23rd of April, Franklin Berger bought around 125k shares on-market at roughly US$16.95 per share. This was the largest purchase by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months.