ZFGN~~84 NEWS~~Zafgen and Chondrial Therapeutics Announce Definitive Merger Agreement
Published: Dec 18, 2019
Creates clinical-stage company focused on the development of novel protein replacement therapies for rare diseases
Chondrial Therapeutics’ lead asset, CTI-1601, currently being evaluated in Phase 1 clinical trial for Friedreich’s ataxia
Companies to host conference call today at 8:30 a.m. ET
BOSTON and BALA CYNWYD, Pa., Dec. 18, 2019 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN) and Chondrial Therapeutics, Inc., today announced they have entered into a definitive merger agreement under which Chondrial will become a wholly-owned subsidiary of Zafgen and the stockholders of Chondrial Therapeutics will become the majority owners of Zafgen’s outstanding common stock upon the close of the merger. The proposed merger will result in a combined publicly traded, clinical-stage biopharmaceutical company operating under a new name, Larimar Therapeutics, Inc.
“We are incredibly pleased to announce this proposed merger, as, once completed, we anticipate it will provide significant resources to advance CTI-1601, our novel therapeutic being developed for patients with Friedreich’s ataxia and expand our efforts on the development of additional potential treatments for other rare diseases,” said Carole Ben-Maimon, M.D., President and Chief Executive Officer of Chondrial Therapeutics. “Our current programs are based on our proprietary novel protein replacement therapy platform, which includes a cell penetrating peptide technology that allows the intracellular delivery of bioactive cargos. With this strong scientific foundation and company evolution, we believe we are well positioned to address complex rare diseases where patients are in need of innovative treatments.”
Chondrial Therapeutics’ lead asset, CTI-1601, is in clinical development for the treatment of Friedreich’s ataxia (FA), a progressive and irreversible mitochondrial disease caused by a genetic defect resulting in abnormally low amounts of frataxin (FXN). FA typically presents in childhood or adolescence and leads to devastating symptoms and early death. The company believes there are approximately 15,000 patients in the U.S and E.U. Currently, there are no cures and no therapies that can modify the course of the disease.
“After a thorough evaluation of strategic alternatives, the Board of Directors of Zafgen believes that this merger represents the highest-potential value creation opportunity for Zafgen stockholders,” said Jeffrey Hatfield, Chief Executive Officer, Zafgen. “We are excited about the prospects for Chondrial Therapeutics and its work to improve the lives of young patients with rare diseases, which aligns with our own values and mission.”
Chondrial Therapeutics separately announced today that Phase 1 dosing in patients began this month and that CTI-1601 has received Rare Pediatric Disease (RPD) Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA). Topline results from the Phase 1 clinical program are expected by the end of 2020.
“Having advanced Chondrial’s novel therapy for Friedreich’s ataxia from the lab to the clinic, we are extremely pleased to join forces with Zafgen for the next phase of the company’s development,” said Jonathan Leff, Partner, Deerfield Management and a Director of Chondrial. “With the financial resources and team in place, we look forward to employing Chondrial’s product engine and platform technology to benefit patients suffering from Friedreich’s ataxia as well as other serious diseases.”
CTI-1601 is comprised of human FXN bound to a carrier peptide. CTI-1601 was designed to cross both the cell membrane and mitochondrial membranes. After processing, mature human frataxin is intended to remain within the mitochondria to function. Nonclinical studies have shown promising results in several models of the disease, including heart, brain and muscle function, and overall survival.
Beyond CTI-1601, Chondrial Therapeutics plans to use its protein replacement therapy platform to design other fusion proteins to target additional orphan diseases characterized by deficiencies in intracellular bioactive compounds.
About the Proposed Merger
Under the terms of the merger agreement, stockholders of Chondrial will receive shares of newly issued Zafgen common shares in a private placement. Chondrial stockholders are expected to own approximately 60% of the combined company and current Zafgen stockholders will own approximately 40% of the combined company. The percentage of the combined company that Chondrial’s stockholders will own as of the close of the transaction is subject to adjustment based on the amount of Zafgen’s net cash at the closing date, among other adjustments as described in the merger agreement.
Upon closing of the transaction, Zafgen will be renamed Larimar Therapeutics, Inc. and will be headquartered in Bala Cynwyd, Pennsylvania. Carole Ben-Maimon, M.D. will serve as President and Chief Executive Officer of the combined company. The merger agreement provides that the Board of Directors of the combined company will be comprised of Peter Barrett, Ph.D., Carole Ben-Maimon, M.D., Thomas Daniel, M.D., Thomas Hamilton, Jonathan Leff, Frank Thomas, and one designee of Deerfield Management. The merger agreement has been unanimously approved by the Board of Directors of each company. The transaction is expected to close in the first half of 2020, subject to approvals by stockholders of each company and other customary closing conditions.
MTS Health Partners, L.P. is serving as the exclusive financial advisor to Zafgen and Goodwin Procter LLP is serving as legal counsel to Zafgen. McCarter & English, LLP is serving as legal counsel to Chondrial.
Conference Call Information
Zafgen and Chondrial Therapeutics will host an investor conference call today, December 18, 2019, at 8:30 a.m., Eastern Time, to discuss the merger as well as other forward-looking information. Investors and other interested parties may participate by dialing (844) 824-7428 in the United States or (973) 500-2177 outside the United States and referencing conference ID number 5688136. The call will also be webcast live on the Company's website at https://zafgen.gcs-web.com/events-and-presentations. A replay of this conference call will be available beginning at 11:30 a.m. ET on December 18, 2019 through December 25, 2019 by dialing (855) 859-2056 in the United States or (404) 537-3406 outside the United States. To access the replay please provide Conference ID number 5688136.
Zafgen (Nasdaq:ZFGN) is a biopharmaceutical company that has leveraged its proprietary MetAP2 biology platform to pioneer the study of MetAP2 inhibitors in both common and rare metabolic disorders. Learn more at www.zafgen.com.
About Chondrial Therapeutics
Chondrial Therapeutics is a clinical-stage biotechnology company focused on the treatment of complex rare diseases. The company’s lead compound, CTI-1601, is currently being evaluated in a Phase 1 clinical program as a potential treatment for Friedreich’s ataxia, a rare and progressive genetic disease. Chondrial Therapeutics also plans to use its protein replacement therapy platform to design other fusion proteins to target additional orphan diseases characterized by deficiencies in intracellular bioactive compounds. Learn more at www.chondrialtherapeutics.com.
Additional Information about the Proposed Merger and Where to Find It
This communication relates to the proposed merger transaction involving Zafgen, Inc. (“Zafgen”) and Chondrial Therapeutics, Inc. (“Chondrial”) and may be deemed to be solicitation material in respect of the proposed merger involving Zafgen and Chondrial. In connection with the proposed merger, Zafgen intends to file relevant materials with the Securities and Exchange Commission (the “SEC”), including a proxy statement relating to the approval of the merger agreement. Investors and security holders of Zafgen are urged to read these materials when they become available because they will contain important information about Zafgen, Chondrial and the proposed merger. The proxy statement and other relevant materials (when they become available), and any other documents filed by Zafgen with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Zafgen by directing a written request to: Zafgen, Inc., 3 Center Plaza, Suite 610, Boston, Massachusetts 02108, Attention: Secretary. Investors and security holders are urged to read the proxy statement and other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Participants in the Solicitation
Zafgen and its directors and executive officers and Chondrial and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Zafgen in connection with the proposed merger. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the proxy statement referred to above. Additional information regarding the directors and executive officers of Zafgen is also included in Zafgen’s definitive proxy statement in connection with its 2019 Annual Meeting of Stockholders filed with the SEC on April 26, 2019. These documents are available free of charge at the SEC web site (www.sec.gov) and from the Secretary of Zafgen at the address above.
Zafgen Forward-Looking Information is Subject to Risks and Uncertainty
This communication contains forward-looking statements based upon Zafgen’s and Chondrial’s current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements about the structure, timing and completion of the proposed merger; the combined company’s listing on Nasdaq after the closing of the proposed merger; expectations regarding the ownership structure of the combined company; the combined company’s expected cash position at the closing of the proposed merger; the future operations of the combined company; the nature, strategy and focus of the combined company; the development andcommercial potential and potential benefits of any product candidates of the combined company; the executive and board structure of the combined company; the location of the combined company’s corporate headquarters; and other statements that are not historical fact. Actual results and the timing of events may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation: (i) the risk that the conditions to the closing of the proposed merger are not satisfied, including the failure to timely obtain stockholder approval for the proposed merger, if at all; (ii) uncertainties as to the timing of the consummation of the proposed merger and the ability of each of Zafgen and Chondrial to consummate the proposed merger; (iii) risks related to Zafgen’s ability to manage its operating expenses and its expenses associated with the proposed merger pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed merger; (v) the risk that as a result of adjustments to the exchange ratio, Zafgen stockholders and Chondrial stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Zafgen’s common stock relative to the exchange ratio; (vii) unexpected costs, charges, expenditures or expenses resulting from the proposed merger; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed merger; (ix) Zafgen’s ability to retain personnel as a result of the announcement or completion of the proposed merger; and (x) risks associated with the possible failure to realize certain anticipated benefits of the proposed merger, including with respect to future financial and operating results. Actual results and the timing of events may differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled “Risk Factors” in Zafgen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the SEC, and in other filings that Zafgen makes and will make with the SEC in connection with the proposed merger, including the proxy statement described above under “Additional Information about the Proposed Merger and Where to Find It.” You should not place undue reliance on these forward-looking statements, which apply only as of the date of this communication. Zafgen expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media/Investor Relations Contacts:
Chief Financial Officer
Ten Bridge Communications
Now they can concentrate on finding some positive results with FDA guidelines set and letting go unneeded personal. $5.00 stock again soon.
"The in vitro assays we presented to the FDA reflect Zafgen's deep understanding of the significant difference of ZGN-1061 on endothelial cell biology as compared to our prior compound and we believe represent a truly sophisticated and optimized approach to evaluate important safety information about ZGN-1061," said Priya Singhal, M.D., M.P.H, Head of Research and Development. "We are working to rapidly implement the in vivo animal study, which aims to establish the relevance of the in vitro mechanism and safety margins. We appreciate the FDA's thorough feedback and continuing collaboration throughout this process."
Given the current status and expected timelines of Zafgen's development programs, the Company has implemented plans to reduce its operating expenses and prioritize key resources, with an immediate corporate restructuring as well as other strategies to preserve resources. This restructuring includes a workforce reduction of approximately 25%, in addition to other attrition in 2019. With these changes, Zafgen now expects its projected cash runway to last greater than two years, given its current operating plan.
"Since our constructive Type A meeting with the FDA earlier this year, we've been focused on gaining clarity on the path forward, reaching agreement on the in vivo study design and protocol, and preparing for strong initiation and execution of the study," said Jeffrey Hatfield, Chief Executive Officer. "As we move ahead with ZGN-1061 having accomplished these goals, we have also taken steps to ensure the effective use of capital as we look to the future. This includes the difficult but prudent decision to restructure at this time. We are deeply grateful for the entire team's dedication and many contributions."
$ZFGN Zafgen, Inc. (NASDAQ:ZFGN) has 92 institutional investors and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 28,642,877 shares. Largest shareholders include Atlas Venture Advisors, Inc., Great Point Partners Llc, Armistice Capital, Llc, Farallon Capital Management Llc, Vanguard Group Inc, FMR LLC / Fidelity, AWM Investment Company, Inc., 683 Capital Management, LLC, Mangrove Partners, and BlackRock Inc..
Zafgen, Inc. (NASDAQ:ZFGN) ownership structure shows current positions in the company by institutions and funds, as well as latest changes in position size. Major shareholders can include individual investors, mutual funds, hedge funds, or institutions. The Schedule 13D indicates that the investor holds more than 5% of the company and intends to actively pursue a change in business strategy.
Love these left for dead plays as some big money can be made. Been adding on the sell off now waiting for the payoff on an FDA go. GLTY
JMP Securities invites you to attend its annual life sciences equity research conference, which brings institutional investors together with senior executives of leading publicly traded and privately held companies in the areas of biopharmaceuticals, biotechnology, and medical devices and technologies. Fireside chats and thematic panel discussions incorporating a range of senior executives, key opinion leaders, practitioners and patients will highlight the primary trends shaping the life sciences marketplace today.
Looking that way and loaded with shares for the long term. GLTY
Zafgen to Present at the JMP Securities Life Sciences Conference
June 13, 2019 16:15 ET | Source: Zafgen, Inc.
BOSTON, June 13, 2019 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, announced today that Jeffrey Hatfield, Chief Executive Officer of Zafgen, Inc. is scheduled to present at the JMP Securities Life Sciences Conference on Thursday, June 20, 2019, at 10:30 a.m. ET.
A live audio webcast and replay of the presentation will be available through the Events and Presentations page of the Investors section of the Company's website (www.zafgen.com) for 90 days following the conclusion of the live event.
Zafgen (Nasdaq:ZFGN) is a clinical-stage biopharmaceutical company leveraging its proprietary MetAP2 biology platform to develop novel therapies for patients affected by complex metabolic diseases. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders and is currently advancing programs for type 2 diabetes, Prader-Willi syndrome and liver diseases. Learn more at www.zafgen.com.
Media/Investor Relations Contacts:
Chief Financial Officer
Ten Bridge Communications
A rare disease focused clinical stage biopharmaceutical company with a pipeline of novel product candidates that are intended
to address unmet need in a variety of metabolic diseases
ZGN 1061 for type 2 diabetes with concomitant obesity and/or NASH
Diabetes market evolving towards therapies with enhanced A1C lowering efficacy and positive effects on common co morbidities (ob esity/NAFLD)
Phase 2 proof of concept trial demonstrated significant A1C lowering efficacy and weight loss, with a safety and tolerability pr ofile generally
comparable to placebo
Nonclinical ZGN 1061 studies have demonstrated significant NASH model efficacy, and complementary efficacy in combination with a GLP 1
Next milestone: Update on development plans by end of 3Q 2019
ZGN 1258 for rare metabolic diseases, including Prader Willi syndrome
Prader Willi syndrome is a rare, lethal disease emerging in childhood, with ~200,000 afflicted worldwide; no current therapeutic options available
Development plans suspended due to unexpected finding in long term toxicology studies
ZGN 1345 for metabolic liver disease
Multiple metabolic related liver diseases exist with high unmet medical need, from NAFLD/NASH to hepatocellular carcinoma
Compound is an orally dosed MetAP2i with high liver concentrations but minimal to no detectable systemic exposure; once daily do sing expected
Named as development candidate 4Q 2018; nonclinical development work underway
March 31, 2019 cash position of $105M; runway expected to extend through at least 2020
1061 Next Steps
Reviewing comprehensive data sets with diabetes/NASH KOLs and potential partners
Important progress made toward addressing the FDA Clinical Hold:
Received FDA Type A meeting minutes to previously announced clinical hold
FDA acknowledged newly developed in vitro assays of human plasma coagulation and tissue factor expression qualitatively
differentiate ZGN 1061
Working with FDA to translate in vitro data and confirm relevant safety margins in an in vivo model
Exploring a second IND in a population with higher unmet medical need
Company expects to provide an update on development plans by end of 3Q 2019
Submitting abstracts to present full results of the Phase 2 clinical trial at upcoming medical meetings in 2019
Unexpected finding observed in long term toxicology studies
Degeneration and other anomalies in muscle tissue from 4 and 6 month rodent studies
Observed in different degrees in both vehicle and all dose arms; finding more pronounced at higher doses
Finding never observed previously, specific to ZGN 1258
Not seen in prior ZGN 1258 rodent studies
Not seen in any other species with ZGN 1258
Not seen in any other Zafgen MetAP2i program in any long term toxicology study
Plan to file an IND suspended while finding is investigated
Company will provide an update at a later time, if warranted, following further evaluation
PWS Commitment Continues
PATH for PWS natural history study collaboration continues
Study being conducted in collaboration with the Foundation for
Prader Willi Research (FPWR) and National Organization for Rare
PATH for PWS designed as 4 year / 500 participant non interventional
natural history study
Enrollment kicked off at FPWR annual conference in October; >400
enrolled as of March 2019
1345 Oral, Liver Focused MetAP2 Inhibitor
ZGN 1345 advanced to development candidate status in 4Q 2018
Orally dosed MetAP2i; expected once daily dosing
High concentrations in the liver; minimal to no detectable exposure systemically
High MetAP2 levels strongly correlated with more severe outcomes in advanced liver disease
Positive early data in multiple nonclinical liver disease models with high unmet medical need; further nonclinical
Been green for 2 days on heavy accumulation. Something BIG is coming?
Squeeze or fast trak ?
Cowen & Co. analyst Yaron Werber maintained a Hold rating on Zafgen today. The company’s shares opened today at $1.35, close to its 52-week low of $1.25.
According to TipRanks.com, Werber is a 4-star analyst with an average return of 12.5% and a 61.2% success rate. Werber covers the Healthcare sector, focusing on stocks such as Ultragenyx Pharmaceutical, Inc., Rocket Pharmaceuticals Inc, and Unum Therapeutics Inc.
Phase 3 on its way.....
News: $ZFGN Zafgen Presented Full Results of Phase 2 Clinical Trial for ZGN-1061 at the American Diabetes Association's 79th Scientific Sessions
Delivered comprehensive oral presentation on both cohorts of the clinical trial, including previously announced results for second cohort evaluating doses up to 1.8 mg Company also presented data demonstrating that treatment with ZGN-1061 improves measures of insulin sensitivity and b...
Find out more https://marketwirenews.com/news-releases/zafgen-presented-full-results-of-phase-2-clinical-trial-for-zgn-1061-at-the-american-diabetes-association-s-79th-scientific-sessions-8329472.html
Zafgen Presented Full Results of Phase 2 Clinical Trial for ZGN-1061 at the American Diabetes Association's 79th Scientific Sessions
Mon June 10, 2019 7:00 AM|GlobeNewswire|About: ZFGN
Delivered comprehensive oral presentation on both cohorts of the clinical trial, including previously announced results for second cohort evaluating doses up to 1.8 mg
Company also presented data demonstrating that treatment with ZGN-1061 improves measures of insulin sensitivity and beta-cell function
BOSTON, June 10, 2019 (GLOBE NEWSWIRE) -- Zafgen (ZFGN), Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, today announced that the Company presented the full results of its Phase 2 clinical trial for ZGN-1061 in an oral presentation at the American Diabetes Association's 79th Scientific Sessions. Zafgen also presented a poster on data demonstrating that treatment with ZGN-1061 improved measures of glycemic control, including insulin sensitivity and beta-cell function.
Zafgen previously announced positive results from its Phase 2 clinical trial conducted outside the U.S., including data for the second cohort that included doses up to 1.8 mg, in January 2019. The clinical trial met all of its primary objectives at the 1.8 mg dose, which included glycemic control, or change in A1C, and safety and tolerability. The 12-week data demonstrated that treatment with the 1.8 mg dose of ZGN-1061 produced substantially more improvement in A1C versus placebo than the 0.9 mg dose versus placebo. Progressive and notable reduction in body weight also occurred in patients treated with the 1.8 mg dose. The data showed a favorable safety and tolerability profile for ZGN-1061, with no treatment-related serious adverse events and no cardiovascular (CV) safety signals observed in the trial.
The Phase 2 clinical trial also examined the effects of ZGN-1061 on other markers of glycemic control. In data presented during the poster session, patients who participated in a mixed-meal tolerance test demonstrated significant improvements in postprandial glucose excursion with ZGN-1061 (p<0.001 for both the 0.9 and 1.8 mg doses) and a trend for improvement in insulin levels from baseline to Week 12. ZGN-1061 also demonstrated improvement in beta-cell function and insulin sensitivity in an exploratory combined analysis of 0.9+1.8 mg ZGN-1061 (p=0.02 and p=0.07) using a modeling approach. These data suggest improved glycemic control with ZGN-1061 may be driven by changes in insulin sensitivity and beta-cell function in this population of patients with advanced diabetes.
The poster will be available on the Company’s website.
Zafgen is a clinical-stage biopharmaceutical company leveraging its proprietary MetAP2 biology platform to develop novel therapies for patients affected by complex metabolic diseases. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders. Learn more at www.zafgen.com.
End of June...accumulation going on as time goes by.
PT is 6 and above if fda will green light the new drug investigation.
The company is optimistic.
"We believe the new in vitro data generated was encouraging, and the FDA was helpful with guidance regarding data needed to move forward in type 2 diabetes," Zafgen CEO Jeffrey Hatfield said in a statement.
Zafgen said it is evaluating serious, rare disease indications for which ZGN-1061 could be useful.
The FDA was supportive of Zafgen seeking guidance on a second investigational new drug application for ZGN-1061 as appropriate.
Zafgen is set to provide an update on development plans by the end of the third quarter.
ZFGN double whammy, CMO resigns, scrapped drug plans
2 yr. low