DYRK1A

Clinical trials slated to begin next year in collaboration with global leader LOUISVILLE, Ky., July 10, 2024 /PRNewswire/ -- PharmassêtX Inc., a late-preclinical stage pharmaceutical development company, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to epigallocatechin gallate (EGCG), a well-characterized component of green tea that the Company is developing as a high-purity, high-potency drug for the treatment of inflammatory bowel disease (IBD). Continue Reading FDA granted PharmassêtX ODD for the treatment of pouchitis, a rare yet debilitating form of IBD experienced by a number of patients who have undergone surgery to remove their large intestine. There is currently no FDA-approved drug for the treatment of pouchitis. PharmassêtX announces FDA Orphan Drug Designation for inflammatory bowel disease (IBD) indication pouchitis. Post this "We are grateful to be positioned to provide a much-needed innovative drug, for which there is already substantial evidence of safety and effectiveness, to the underserved community of pouchitis patients," said Terry Minton, Co-Founder and CEO of PharmassêtX. "Our mission as an organization is to improve outcomes and enhance quality of life for IBD patients. The granting of this ODD is an important milestone along the critical path to accomplishing that mission." Peer-reviewed evidence supporting EGCG's safety and effectiveness for an IBD indication was first published in the journal Inflammatory Bowel Diseases, a publication of the Crohn's and Colitis Foundation. A randomized, double-blinded, placebo-controlled, investigator-initiated clinical study of an EGCG-enriched green tea extract showed that patients suffering from mild to moderate ulcerative colitis, a common form of IBD, experienced clinical improvement, including endoscopic improvement, after treatment. No serious adverse events were reported. Further peer-reviewed evidence of EGCG's safety and effectiveness was gathered in the course of an investigator-initiated retrospective study of pouchitis patients published in International Journal of Colorectal Diseases, a Springer Nature publication. The majority of refractory pouchitis patients experienced complete relief from their symptoms, with no serious adverse events reported. Such studies, initiated and completed prior to the formation of the Company by one of its founders, Gerald W Dryden, Jr, MD, PhD, gastroenterologist/immunologist and Chief Medical Officer of PharmassêtX, established the basis for the Company's founding. Dr Dryden offered this perspective: "My clinical experience, consistent with the clinical experience of prominent and knowledgeable colleagues both in the US and globally, indicates that EGCG is safe and effective for the treatment of various forms of IBD. It is unfortunate that previous development efforts to harness partially pure EGCG for the chemoprevention of cancer – a noble goal, but a high bar indeed – were abandoned. That decision was made not because of lack of evidence of efficacy or safety; rather, a change in leadership at the former corporate sponsor, a prominent tea producer, led to their change of heart. The rigorous demands and high costs of pharmaceutical development fell outside of their corporate risk tolerance. Ever since, there has been a pressing need to revive the development of EGCG as a drug to treat conditions such as IBD, including pouchitis. PharmassêtX was founded to meet that unmet medical need." EGCG has been shown to target NF-κB, a key regulator of mucosal immunity, which promotes the expression of multiple pro-inflammatory genes dysregulated in IBD. Additional effects may include decreased activation of the NLRP3 inflammasome, decreased secretion of pro-inflammatory interleukins, and promotion of intestinal barrier integrity. Studies in relevant IBD models suggest that targeting NF-κB can be an effective strategy in disease management, whether alone or as an adjunct in combination with other therapeutics. To advance its proprietary ultra-pure EGCG drug PSX-514 into the clinic as efficiently as possible, PharmassêtX has recently partnered with Alimentiv, a Canada-based global contract research organization recognized as the leader in designing and executing clinical trials of novel therapeutics for gastrointestinal indications, including various forms of IBD such as Crohn's disease, ulcerative colitis, and pouchitis. The collaboration with Alimentiv is intended to expedite patient access to PSX-514 and advance the drug into the clinic next year. Such clinical validation is required for eventual regulatory approval and, importantly, so that public and private insurers will have data supporting coverage and payment for PSX-514 prescriptions on the basis of medical necessity. Per-insured per-year costs for IBD patients are significantly higher than for insured patients in general, indicating the need for more innovative and cost-effective therapeutics. About inflammatory bowel disease: A groundbreaking 2023 study led by the Crohn's and Colitis Foundation showed that nearly 1 in 100 Americans has IBD. "IBD is an umbrella term used to describe disorders that cause chronic inflammation of the gastrointestinal (GI) tract. Symptoms include diarrhea, as well as abdominal pain, nausea, fever, loss of appetite, fatigue and at times rectal bleeding. The two most common forms of IBD are Crohn's disease and ulcerative colitis. There are currently no cures for IBD." See the Crohn's and Colitis Foundation website, . About pouchitis: "Pouchitis is the most common complication after restorative proctocolectomy with ileal pouch–anal anastomosis for ulcerative colitis." See "AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders" at . About Orphan Drug Designation: "Supporting the development and evaluation of new treatments for rare diseases is a key priority for the FDA. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including: tax credits for qualified clinical trials; exemption from user fees; potential seven years of market exclusivity after approval." See the FDA website, . About EGCG: Epigallocatechin gallate (EGCG) is a natural substance obtained from the tea plant Camellia sinensis. As evidenced by over four thousand peer-reviewed publications just in the past decade, EGCG has become the object of extensive research into its health effects and other properties. See the National Institutes of Health National Center for Biotechnology Information PubChem website, . About Gerald W Dryden, Jr, MD, PhD: Dr Dryden is Professor of Medicine at the University of Louisville School of Medicine, inventor of a number of endoscopic devices, co-author of dozens of publications on IBD, and a frequent invited speaker at gastroenterology conferences focused on improving IBD treatment. About Terry Minton: Mr Minton is an experienced healthcare executive, working most recently in pharmacogenomics and diagnostics, who has launched multiple startups including oncology drug developer Aptamera, which was acquired for a premium yielding a highly attractive ROI for its investors. About Alimentiv: Alimentiv is an industry-leading specialty GI contract research organization (CRO) improving clinical trial outcomes and accelerating drug development timelines. As a global CRO offering clinical, medical imaging and precision medicine services, Alimentiv partners with pharmaceutical and biotechnology industries to advance the development of novel therapies. Alimentiv is headquartered in London, Ontario, Canada, with a global footprint across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. For more information: . About PharmassêtX: Founded in 2024 with a mission to address the needs of underserved populations within the IBD community, Louisville, Kentucky-based PharmassêtX Inc. (pronounced "Farm-a-SET-x") is a privately held Delaware corporation. The Company welcomes substantive inquiries from interested parties. Contact: Terry Minton, CEO, PharmassêtX, [email protected] or (502) 324-5111. Note: This press release contains forward-looking statements, including without limitation statements about future developments, which are subject to significant risks and uncertainties. Actual future developments may differ materially due to various factors. PharmassêtX Inc. undertakes no obligation to update or revise any forward-looking statement. No reliance should be placed on any forward-looking statement contained in this press release. SOURCE PharmassêtX Inc.

Cash and cash equivalents of approximately $11.5 million as of October 31, 2023 Special meeting of stockholders on November 16 seeking stockholder approval of the Dissolution and Plan of Dissolution If approved by stockholders, the Company estimates that cash distributions in the Dissolution will be between $5 million and $7 million, or $0.84 to $1.17 per share, to stockholders BOULDER, Colo., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Fresh Tracks Therapeutics, Inc. (the “Company” or “Fresh Tracks”) (Nasdaq: FRTX), today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update. “Following the approval by our Board of a plan of liquidation and dissolution of the Company, we have taken numerous actions over the last few weeks to reduce operating expenses and conserve capital, with the primary goal of maximizing the remaining cash available to distribute to stockholders if the dissolution is approved,” commented Albert (Bert) N. Marchio, II, Fresh Tracks’ Chief Executive Officer, Chief Financial Officer, and director and Chairman of the Board. “As we move towards the special meeting of stockholders next week, we urge all stockholders to review the definitive proxy statement we filed with the SEC on October 20, 2023 and encourage them to vote as soon as possible. If the dissolution is approved at the special meeting, we intend to promptly file a Certificate of Dissolution with the Secretary of the State of Delaware and subsequently initiate the first of several liquidating cash distributions to stockholders.” Recent Corporate Highlights On September 19, 2023, Fresh Tracks announced a proposed plan of liquidation and dissolution (the “Plan of Dissolution”) and its intent to discontinue all clinical and preclinical development programs and reduce the Company’s workforce. Historically, Fresh Tracks was a clinical-stage pharmaceutical company striving to transform patient lives through the development of innovative and differentiated prescription therapeutics. The Company’s pipeline aimed to disrupt existing treatment paradigms and featured several new chemical entities that inhibit novel targets with first-in-class potential for autoimmune, inflammatory, and other debilitating diseases. The Company’s board of directors (“Board”) and executive management team conducted a comprehensive process to explore and evaluate strategic alternatives with the goal of maximizing stockholder value. Potential alternatives that were under evaluation included, but were not limited to, a financing, a merger or reverse merger, the sale of all or part of the Company, licensing of assets, a business combination, and/or other strategic transactions or series of related transactions involving the Company. On September 18, 2023, after conducting an extensive, months-long potential strategic alternatives process, including four unsuccessful attempts to find a merger or reverse merger partner due to the potential acquirer’s inability to secure its own necessary financing and/or inability to offer adequate value to consummate the transaction, and combined with the unsuccessful outreach to approximately 125 other possible counterparties and investors who operate or invest in both life sciences and other industry sectors, the Board unanimously approved the Company’s proposed liquidation and dissolution (the “Dissolution”) and the Plan of Dissolution, subject to the approval of the Company’s stockholders. In connection with the Plan of Dissolution, effective October 2, 2023, the Company discontinued all clinical and preclinical development programs and terminated most of its employees, except for certain employees, consultants, and advisors who will supervise or facilitate the dissolution and wind down of the Company, if approved by the Company’s stockholders. Fresh Tracks plans to hold a special meeting of stockholders on November 16, 2023 (the “Special Meeting”) to seek stockholder approval of the Dissolution and the Plan of Dissolution and has filed proxy materials relating to the Special Meeting with the Securities and Exchange Commission (“SEC”). If the Dissolution and the Plan of Dissolution are approved by the Company’s stockholders, based on currently available information, the Company estimates that it will have in the range between approximately $5.0 million and $7.0 million of cash available to be distributed to stockholders in connection with the Dissolution, which implies a per share distribution range of $0.84 to $1.17 per share of common stock. Distributions, if any, to the Company’s stockholders may be paid in one or more distributions over a period of several years. Such distributions will not occur until after the Certificate of Dissolution is filed, which the Company intends to do as soon as practicable after stockholder approval, if such approval is obtained. The Board of Directors fixed the close of business on October 17, 2023, as the record date for the Special Meeting. Only stockholders of record at the close of business on that date may vote at the Special Meeting or any adjournment thereof. Your vote is important. If you have questions about how to vote, please call the Company’s proxy solicitor D.F. King at 800-769-4414 (or international: 914-218-4628). Third Quarter 2023 Financial Results The Company reported cash and cash equivalents of $12.0 million as of September 30, 2023, compared to $8.7 million as of December 31, 2022. As of October 31, 2023, the Company’s cash balance was approximately $11.5 million. Revenue was $7.9 million for the third quarter of 2023, compared to $0.5 million for the third quarter of 2022. Revenue for the third quarter of 2023 primarily consisted of contract revenue of $7.9 million recognized pursuant to its Asset Purchase Agreement Amendment with Botanix SB Inc. (“Botanix”) and Botanix Pharmaceuticals Limited (the “Asset Purchase Agreement”), in which the Company agreed to terminate and relinquish any remaining amounts potentially payable by Botanix to the Company in the future. Revenue for the third quarter of 2022 primarily consisted of contract revenue recognized under the Asset Purchase Agreement and a Transition Services Agreement with Botanix. Research and development expenses were $0.6 million for the third quarter of 2023, compared to $3.6 million for the third quarter of 2022. The decrease was primarily driven by decreased expenses of $2.3 million related to the Company’s DYRK1A inhibitor program and $0.6 million for personnel and other unallocated expenses. General and administrative expenses were $5.3 million for the third quarter of 2023, compared to $3.0 million for the third quarter of 2022. The increase of $2.3 million was primarily the result of $1.7 million for a licensing fee to the Company’s former licensor in July 2023 under the Asset Purchase Agreement Amendment and $1.1 million in higher compensation-related expenses primarily due to severance expense, partially offset by $0.5 million in lower legal and compliance fees. The Company reported net income of $2.1 million for the third quarter of 2023 compared to a net loss of $6.0 million for the third quarter of 2022. IMPORTANT ADDITIONAL INFORMATION AND WHERE TO FIND IT This press release is for informational purposes only. It is neither a solicitation of a proxy, an offer to purchase, nor a solicitation of an offer to sell shares of the Company. In connection with the proposed Dissolution and the Plan of Dissolution, the Company filed a definitive proxy statement with the SEC on October 20, 2023. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER SOLICITING MATERIALS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED DISSOLUTION, THE PLAN OF DISSOLUTION AND RELATED MATTERS, AND/OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT FRESH TRACKS, THE PROPOSED DISSOLUTION, THE PLAN OF DISSOLUTION AND RELATED MATTERS. Stockholders may obtain a free copy of the definitive proxy statement and the other relevant materials, and any other documents filed by the Company with the SEC, at the SEC's website at http://www.sec.gov or on the “Investors” section of Fresh Track’s website at www.frtx.com. Participants in the Solicitation Fresh Tracks and its executive officers and directors may be deemed to be participants in the solicitation of proxies from its stockholders with respect to the proposed Dissolution, the Plan of Dissolution and related matters, and any other matters to be voted on at the Special Meeting. Information regarding the names, affiliations and direct or indirect interests, by security holdings or otherwise, of such directors and executive officers in the solicitation are included in the definitive proxy statement filed with the SEC on October 20, 2023. Additional information regarding such directors and executive officers, and other important Company information, are included in Fresh Track’s Annual Report on Form 10-K/A for the year ended December 31, 2022, which was filed with the SEC on May 1, 2023. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies of Fresh Track’s stockholders in connection with the proposed Dissolution, the Plan of Dissolution and related matters are set forth in the definitive proxy statement. These documents are available free of charge as described in the preceding section. For more information, visit https://www.frtx.com. Cautionary Note Regarding Forward-Looking Statements Any statements made in this press release relating to future financial, business, conditions, plans, prospects, impacts, shifts, trends, progress, or strategies and other such matters, including without limitation, Fresh Tracks’ proposed Dissolution pursuant to its Plan of Dissolution, the timing of filing of the Certificate of Dissolution, the timing and outcome of the Special Meeting to approve the Dissolution and the Plan of Dissolution, the amount, number, and timing of liquidating distributions, if any, to its stockholders, the amount of reserves, and similar statements, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “might,” “show,” “continue,” “conduct,” “report,” “seek,” “report,” “conserve,” “distribute,” “dissolve,” “encourage,” “discontinue,” “terminate,” “wind down,” “additional,” “announce,” “anticipate,” “believe,” “sufficient,” “estimate,” “expect,” “intend,” “plan,” “potential,” “will,” “evaluate,” “aim,” “meet,” “support,” “look forward,” “develop,” “promise,” “provide,” “first-in-class,” “opportunity,” “disrupt,” “reduce,” “suggest,” and similar expressions and their variants, as they relate to Fresh Tracks or any of Fresh Tracks’ partners, or third parties, may identify forward-looking statements. Fresh Tracks cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly, and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include the availability, timing and amount of liquidating distributions being different than expected; the amounts that will need to be set aside as reserves by Fresh Tracks being higher than anticipated; the possible inadequacy of such reserves to satisfy Fresh Tracks’ obligations; potential unknown contingencies or liabilities, and Fresh Tracks’ potential inability to favorably resolve them or at all; the amount of proceeds that might be realized from the sale or other disposition of any remaining Fresh Tracks assets; the application of, and any changes in, applicable tax and other laws, regulations, administrative practices, principles and interpretations; the incurrence by Fresh Tracks of expenses relating to the Dissolution being different than estimated; the ability of the Fresh Tracks board of directors to abandon, modify or delay implementation of the Dissolution, even after stockholder approval; failure of the Company’s stockholders to approve the proposed Plan of Dissolution; the Company’s ability to settle, make reasonable provision for or otherwise resolve its liabilities and obligations, including the establishment of an adequate contingency reserve; and the uncertain macroeconomic and political environment. Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Fresh Tracks’ filings with the SEC, which are available at https://www.sec.gov (or at https://www.frtx.com). The forward-looking statements represent the estimates of Fresh Tracks as of the date hereof only. Fresh Tracks specifically disclaims any duty or obligation to update forward-looking statements. Fresh Tracks Therapeutics, Inc.Investor Contact:Dan FerryLifeSci Advisors(617) 430-7576daniel@lifesciadvisors.com Fresh Tracks Therapeutics, Inc.Condensed Consolidated Statements of Operations(in thousands, except share and per share data)(unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2023 2022 2023 2022 Revenue Contract revenue$7,944 $486 $8,006 $4,801 Royalty revenue — — — 92 Total revenue 7,944 486 8,006 4,893 Operating expenses: Research and development 627 3,560 3,172 11,438 General and administrative 5,320 3,002 9,542 10,396 Total operating expenses 5,947 6,562 12,714 21,834 Income (loss) from operations 1,997 (6,076) (4,708) (16,941)Other income 107 58 257 372 Interest expense — — (5) (6)Net income (loss) 2,104 (6,018) (4,456) (16,575)Less: net income attributable to participating securities (197) — — — Net income (loss) attributable to common stockholders$1,907 $(6,018) $(4,456) $(16,575) Net income (loss) per common share attributable to common stockholders, basic and diluted$0.32 $(2.07) $(0.86) $(6.05)Weighted-average shares used to compute net income (loss) per share attributable to common stockholders, basic and diluted 5,912,786 2,906,000 5,199,856 2,738,954 Fresh Tracks Therapeutics, Inc.Selected Financial InformationCondensed Consolidated Balance Sheet Data(amounts in thousands)(unaudited) September 30,2023 December 31,2022Cash and cash equivalents$12,020 $8,680Prepaid expenses and other current assets 993 1,403Total assets 13,057 10,271Total liabilities 2,108 3,077Total stockholders’ equity 10,949 7,194

Pictured: Closed sign being flipped over/iStock, StockSeller_ukr Colorado-based pharma Fresh Tracks announced Tuesday that its board of directors had unanimously agreed to dissolve the company and liquidate its assets, while California biotech Histogen on Monday also announced that it was dissolving and liquidating its business. Fresh Tracks will discontinue all its clinical and preclinical development programs as well as lay off “most employees,” which is set to happen by early October 2023, according to the company’s announcement. The news comes after the company’s search for potential strategic alternatives to save its business had turned up empty. However, Fresh Tracks will retain consultants, advisors and certain employees who are involved in the company’s dissolution. The company’s liquidation is still pending final approval from its shareholders. A day before Fresh Tracks announced its closure plans, San Diego-based Histogen said that it was dissolving and liquidating its business. Like its Colorado counterpart, Histogen has opted to discontinue all clinical development programs and has drastically slimmed down its workforce as part of its dissolution plan. Most employees will be laid off by the end of September 2023, according to the company’s announcement. Fresh Tracks was launched in September 2022 from a sweeping rebranding of Brickell Biotech. At the time, former CEO Robert Brown said that the company’s new name reflects the company’s mission “to develop groundbreaking, novel therapies that have the potential to restore immune balance.” Brown retired in January 2023 and was succeeded by Andew Sklawer. The company has since advanced a pipeline of immunology assets, including the DYRK1A inhibitor FRTX-02, which was in Phase I assessments for atopic dermatitis and was also being proposed for rheumatoid arthritis and type 1 diabetes. The company also owned an oral STING inhibitor, dubbed FRTX-10, which was in preclinical development for systemic lupus erythematosus, dermatomyositis and non-alcoholic steatohepatitis. In its most recent earnings report, posted August 2023, Fresh Tracks announced that it had “paused substantially all of its research and development activities in order to conserve capital resources.” In a previous earnings call soon after its rebrand, the company indicated that it was looking at strategic options including financing, merger or reverse merger, business combination or the sale of part of the company. Under its plan of dissolution, Histogen is considering selling off its pipeline assets—the proceeds from which would be distributed to stockholders along with its remaining cash. The proposed dissolution is still pending approval from the company’s stockholders, for which it expects to convene a special meeting in the fourth quarter of this year. Prior to the announcement, Histogen was advancing its experimental bacterial skin infection treatment emricasan. It had received the FDA’s go-ahead in March 2023 to conduct clinical trials for the candidate. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.