Galena Biopharma

From WikiProjectMed
Jump to navigation Jump to search
Galena Biopharma, Inc.
FormerlyRXi Pharmaceuticals
Company typePublic (NasdaqGALE)
IndustryBiotechnology
Founded2006
DefunctDecember 29, 2017 (2017-12-29)
FateAcquired by SELLAS Life Sciences Group
HeadquartersSan Ramon, California, United States
Key people
Mark Schwartz, CEO
ProductsNeuVax
Revenue$7.4 million (2014)
Number of employees
60 (March 2014)
Websitewww.sellaslifesciences.com

Galena Biopharma (originally RXi Pharmaceuticals) was a publicly traded pharmaceutical company based in San Ramon, California. The company was founded in Worcester, Massachusetts. In 2011, it moved to Oregon,[1][2] and in 2015 moved to San Ramon, California.[3] Mark Schwartz was the company's president and chief executive officer.[4][5][6][7] As of December 29, 2017, the company was acquired by Sellas Life Sciences Group Ltd. through a reverse merger transaction. Galena Biopharma was renamed to Sellas Life Sciences Group, Inc (NasdaqSLS).[8]

History

In November 2006, Argonaut Pharmaceuticals, Inc. changed the name to RXi Pharmaceuticals Corporation.[2] RXi was a subsidiary of CytRx Corp., which provided $15 million in financing in April 2007.[9][10] RXi was founded in part by Nobel Prize winner Craig Mello.[9] In September 2007, RXi signed a licensing deal with TriLink Biotechnologies, a competitor in the RNA interference (RNAi) field, in which RXi would pay TriLink to use three of TriLink's technologies.[10]

In March 2011, the company announced the planned acquisition of Arizona-based Apthera, Inc. for $7 million. The acquisition included the breast cancer drug NeuVax.[11] In June 2011, NeuVax was approved by the United States Food and Drug Administration to start a stage three clinical trial.[12]

In September 2011, the company separated its cancer therapies division. It was renamed Galena Biopharma Inc and moved to Lake Oswego, Oregon.[1][11][13] RXi became a subsidiary of Galena and retained RNAi technologies.[13] RXi Pharmaceuticals remained in Massachusetts as a publicly traded company.[1] In January 2014, Galena bought Mills Pharmaceuticals.[14] In April 2014, the company headquarters moved to Portland.[15]

In November 2011, the company partnered with Genentech to combine drugs from each company for a cancer treatment.[16][17] Galena is currently studying the combination of NeuVax and Herceptin in phase II trials.[18]

Leadership

In March 2011, president and CEO Noah Beerman were replaced by Mark Ahn, and in August 2014, Ahn resigned and was replaced by Mark Schwartz.[6][7] On January 31, 2017, Galena announced the resignation of Mark Schwartz effective that day, and reported in the same press release that it would be exploring strategic alternatives to maximize shareholder value going forward.[19]

Stock

RXi went public in March 2008. CytRx retained 49% ownership of RXi's stock and gave shares of RXi to existing shareholders. Trading began on the NASDAQ market on March 12, 2008, under the ticker symbol of RXII.[20][21] Fidelity Investments invested $8.5 million in the company in May 2008,[22] followed by a $25 million private-equity investment by Yorkville in February 2009.[23] In 2010, RXi received a National Institutes of Health grant of $600,000.[24] By August 2010, the company had 30 employees.[24] In April 2011, RXi raised about $12 million from a stock offering[25] and received $580,000 in grants from the National Institutes of Health.[26] The company reported a loss of $11.5 million loss for 2011.[27][28]

In November 2012, an anonymous internet report caused Galena stock to decline. The company filed a lawsuit claiming the report was false and attempted to manipulate the stock.[29] In 2014, Galena's involvement in a fraudulent stock promotion scheme was exposed.[30] On February 1, 2014, analyst Matt Gravitt published an article that revealed Galena had paid MissionIR, DreamTeam brand, to promote Galena's stock.[31] Galena's stock fell 20% following this revelation that received a heated response, and was one of the three most read articles in Seeking Alpha's history.[32][33][34] Over the next few weeks, more revelations came out and the company admitted their stock promotion relationship and insider selling.[35] Galena then disclosed that the SEC was investigation their relationship with The DreamTeam Group.[36][37][38] By March 2014, five lawsuits were filed against Galena and several of its officers alleging that the company used misleading articles to boost stock prices.[35][36] Motley Fool, discussing the 23% stock price drop during March 2015, noted there was stock dilution from the offering and also that Abstral's sales were below Galena's estimates from late 2013.[39] Discussing the Motley Fool article, Portland Business Journal also noted the ongoing insider-trading lawsuits as a factor in the stock price.[40] A few days later, Zacks Investment Research said Galena could be a "great candidate" to beat its earnings.[41] In response, Galena's CEO said there were many positive aspects to the company, and that the lawsuits weren't a worry as they should get covered under Directors and officers liability insurance.[42] The company moved to San Ramon, California, in the Bay Area in 2015.[3]

Stock promotion scandal

The revelation that Galena was engaging in fraudulent stock promotion without adequate disclosure led to the investigation of other biotech companies who engaged in similar activities. Richard Pearson, an investor who went undercover to investigate the stock promotion firms, wrote an exposé on DreamTeam and its ties to articles about Galena, CytRx, and other companies on media websites.[43][44] In April 2017, the Securities and Exchange Commission announced enforcement actions against 27 individuals and entities behind various alleged stock promotion schemes. Fraud charges were filed against three public companies, seven stock promotion or communications firms, and two company CEOs; also on this hit list are six individuals and nine writers.[45][46]

Merger with Sellas Life Sciences

In 2017, Galena Biopharma Inc. announced a merger "with privately-held oncology company Sellas Life Sciences Group Ltd. in an all-stock transaction."[47] The combined company was Sellas Life Science Group. The newly merged companies focused on the development of novel treatments for cancer.[48]

Products

Galena acquired the experimental breast cancer drug NeuVax in 2011 and are currently[when?] in phase II trials to combine the drug with Genentech's Herceptin.[18]

In 2013, Galena began selling its first developed drug, an analgesic for cancer pain named Abstral Sublingual.[4][49]

Anagrelide controlled-released (GALE-401) was approved by the FDA for phase III clinical trials for the treatment of essential thrombocytosis in December 2016.[50]

GALE-301 and GALE-302 are immunotherapies in phase I and II trials for ovarian and breast cancers.[51]

References

  1. ^ a b c Siemers, Erik; Michelle Lang (September 30, 2011). "Galena Biopharma exits Boston for Lake Oswego". Portland Business Journal. Retrieved 31 March 2012.
  2. ^ a b "10-K Annual Report". SEC Filings. Galena Biopharma. Archived from the original on 28 June 2013. Retrieved 31 March 2012.
  3. ^ a b Hayes, Elizabeth (November 11, 2015). "Portland loses a biotech company to the Bay Area". Portland Business Journal. Retrieved 12 November 2015.
  4. ^ a b Hayes, Elizabeth (7 January 2015). "Galena CEO upbeat despite poor stock performance". Portland Business Journal. Retrieved 16 February 2015.
  5. ^ "Ownership of Securities". United States Securities and Exchange Commission. Archived from the original on 17 February 2015. Retrieved 16 February 2015.
  6. ^ a b Pearson, Richard (21 August 2014). "3 Lessons From The Galena Scandal". Seeking Alpha. Retrieved 16 February 2015.
  7. ^ a b "Galena Biopharma CEO Mark Ahn Steps Down, Names Mark Schwartz Replacement". RTT News. 21 August 2014. Archived from the original on 17 February 2015. Retrieved 16 February 2015.
  8. ^ "Sellas Life Sciences Group Successfully Completes Business Combination with Galena Biopharma" (Press release). Sellas Life Sciences Group, Inc. GlobeNewswire. 2017-12-29. Retrieved 2018-11-05.
  9. ^ a b "RXi Pharma to receive $15M from CytRx". Boston Business Journal. April 20, 2007. Retrieved 1 April 2012.
  10. ^ a b "RXi licenses additional RNAi technology". Boston Business Journal. September 11, 2007. Retrieved 1 April 2012.
  11. ^ a b Donnelly, Julie M. (March 31, 2011). "RXi acquires Apthera, names new CEO". Boston Business Journal. Retrieved 1 April 2012.
  12. ^ Donnelly, Julie M. (June 6, 2011). "RXi advances breast cancer vaccine". Boston Business Journal. Retrieved 1 April 2012.
  13. ^ a b Lang, Michelle (September 26, 2011). "RXi to split into two public companies". Boston Business Journal. Retrieved 1 April 2012.
  14. ^ Hayes, Elizabeth (January 13, 2014). "Galena Biopharma acquisition may deliver promising new drug". Portland Business Journal. Retrieved 14 January 2014.
  15. ^ "Amendment to Annual Report" (PDF). Business Entity Filing Records. Oregon Secretary of State. Archived from the original (PDF) on 2 May 2014. Retrieved 1 May 2014.
  16. ^ Leuty, Ron (November 28, 2011). "Genentech, Galena to combine breast cancer therapies in mid-stage trial". San Francisco Business Times. Retrieved 31 March 2012.
  17. ^ Marcial, Gene (March 15, 2012). "Roche Accelerates Defense Strategy to Protect Breast-Cancer Drug Herceptin's Turf". Forbes. Retrieved 31 March 2012.
  18. ^ a b "NeuVax™ + Herceptin®, HER2 1+ 2+ | Galena Biopharma". Archived from the original on 2017-01-05. Retrieved 2017-01-04.
  19. ^ "Galena Biopharma Announces the Resignation of its President and Chief Executive Officer and the Evaluation of Strategic Alternatives". Yahoo Finance. January 31, 2017. Retrieved January 31, 2017.
  20. ^ Hollmer, Mark (February 25, 2008). "Regulators approve novel stock offering for RXi". Boston Business Journal. Retrieved 1 April 2012.
  21. ^ "RXi Pharmaceuticals begins public trading". Boston Business Journal. March 12, 2008. Retrieved 1 April 2012.
  22. ^ Noyes, Jesse (December 15, 2008). "RXi hunkers down for potential deal as cash dries". Boston Business Journal. Retrieved 1 April 2012.
  23. ^ "RXi scores $25M private equity deal". Boston Business Journal. February 6, 2009. Retrieved 1 April 2012.
  24. ^ a b Donnelly, Julie M. (August 9, 2010). "Startup RXi eyes growth by narrowing its focus". Boston Business Journal. Retrieved 1 April 2012.
  25. ^ Lang, Michelle (April 15, 2011). "RXi makes $12M securities offering". Boston Business Journal. Retrieved 1 April 2012.
  26. ^ Lang, Michelle (April 26, 2011). "RXi nabs RNAi grants". Boston Business Journal. Retrieved 1 April 2012.
  27. ^ Giegerich, Andy (March 29, 2012). "Galena Biopharma trimmed losses in 2011". Portland Business Journal. Retrieved 31 March 2012.
  28. ^ Giegerich, Andy (November 14, 2011). "Galena posts year-over-year losses". Portland Business Journal. Retrieved 31 March 2012.
  29. ^ Budnick, Nick (December 2, 2012). "Lake Oswego biotech firm battles Internet critics". The Oregonian. Retrieved 2 December 2012.
  30. ^ "Galena Biopharma, Inc. Securities Litigation, No. 3:2014cv00367". Justia US Law.
  31. ^ "CASE No.:3:14-cv-00367-SI IN RE GALENA BIOPHARMA, INC.SECURITIES LITIGATION, CONSOLIDATED CLASS ACTION COMPLAINT FOR VIOLATIONS OF THE FEDERAL SECURITIES LAWS" (PDF).
  32. ^ "Volume Coverage on HLF, GALE, AEGY, and SING". Yahoo Finance. February 1, 2014.
  33. ^ "Announcing This Week's Performance Award Winners - Joe Springer And Matt Gravitt". Seeking Alpha. February 17, 2015.
  34. ^ Gravitt, Matt (January 31, 2014). "Galena Biopharma: Numerous Red Flags Suggest A Significant Overvaluation". Seeking Alpha.
  35. ^ a b "California investor takes aim at stock promoting, reports Lake Oswego biotech firm". OregonLive.com. Retrieved 20 April 2014.
  36. ^ a b "An Insider's Tale of a Stock Promotion Plan: Galena, CytRx - Barron's". Retrieved 20 April 2014.
  37. ^ "CytRx Corporation (CYTR) news: Behind The Scenes With Dream Team, CytRx And Galena - Seeking Alpha". Seeking Alpha. Retrieved 20 April 2014.
  38. ^ "At financial news sites, stock promoters make inroads - The Term Sheet: Fortune's deals blogTerm Sheet". CNN. Archived from the original on 29 April 2014. Retrieved 20 April 2014.
  39. ^ Williams, Sean (7 April 2015). "Galena Biopharma Inc. Imploded in March -- Here's Why (GALE)". The Motley Fool. Retrieved 7 April 2015.
  40. ^ Hayes, Elizabeth. "Galena stock tanks as biotech darling records slow sales of new drug". American City Business Journals. Retrieved 7 April 2015.
  41. ^ "Can Galena Biopharma (GALE) Keep the Earnings Streak Alive This Quarter?". 9 April 2015. Retrieved 13 April 2015.
  42. ^ Hayes, Elizabeth (13 April 2015). "Galena CEO: 'A lot of noise,' but the biotech company is 'on target'". American City Business Journals. Retrieved 13 April 2015.
  43. ^ "At financial news sites, stock promoters make inroads". Fortune. March 20, 2014.
  44. ^ Pearson, Richard (March 13, 2014). "Behind The Scenes With Dream Team, CytRx And Galena". Seeking Alpha.
  45. ^ "SEC hits out at paid-for bioanalysts, CEOs and firms, charges 27". Fierce Biotech. April 11, 2017.
  46. ^ "27 Firms and Individuals Charged With Fraudulent Promotion of Stocks". SEC.gov. April 10, 2017.
  47. ^ "Troubled Galena swallowed by Sellas". BioPharma Dive. Retrieved 2020-05-18.
  48. ^ BioSpace (2017-08-08). "Galena Biopharma merges with Sellas Life Sciences". PharmaLive. Retrieved 2020-05-18.
  49. ^ Hayes, Elizabeth (October 3, 2013). "Galena launches drug for cancer pain in the U.S." Portland Business Journal. Retrieved 5 October 2013.
  50. ^ Inc, Galena Biopharma (28 December 2016). "Galena Biopharma Confirms Regulatory Pathway for GALE-401 (Anagrelide Controlled Release)". GlobeNewswire News Room. {{cite web}}: |last= has generic name (help)
  51. ^ "GALE-301 & GALE-302 | Galena Biopharma". Archived from the original on 2017-01-05. Retrieved 2017-01-04.