Sagimet Biosciences Announces Closing of Underwriters’ Option to Purchase Additional Shares of Series A Common Stock in Connection with its Upsized Initial Public Offering

SAN MATEO, Calif., Aug. 15, 2023 (GLOBE NEWSWIRE) — Sagimet Biosciences Inc. (“Sagimet”) (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today announced the closing of the sale of an additional 714,272 shares of Series A common stock at the initial public offering price of $16.00 per share pursuant to the partial exercise of the underwriters’ option to purchase additional shares, in connection with its initial public offering that closed on July 18, 2023. All of the shares of Series A common stock sold in the initial public offering were offered by Sagimet. After giving effect to the partial exercise of the underwriters’ option to purchase additional shares, Sagimet has issued a total of 6,026,772 Series A common stock in the initial public offering for aggregate gross proceeds of approximately $96.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sagimet.

Goldman Sachs & Co. LLC, Cowen and Company, LLC and Piper Sandler & Co. acted as joint book-running managers for the offering. JMP Securities LLC acted as the lead manager for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on July 13, 2023. This offering was made only by means of a written prospectus. Copies of the final prospectus may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by telephone at (833) 297-2926, or by email at prospectus_ecm@cowen.com; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at prospectus@psc.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state, province, territory or other jurisdiction.

About Sagimet Biosciences

Sagimet is a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of nonalcoholic steatohepatitis (NASH), for which there are no treatments currently approved in the United States or Europe. Denifanstat is currently being tested in FASCINATE-2, a Phase 2b clinical trial in NASH with liver biopsy as the primary endpoint. For additional information about Sagimet Biosciences, please visit www.sagimet.com.

LightForce Orthodontics Secures $80 Million Series D Funding Led By Ally Bridge Group

LightForce Orthodontics will expand its manufacturing capabilities to advance production and further its custom orthodontic treatments using AI and 3D printing.

BURLINGTON, MA — August 2, 2023 — LightForce Orthodontics, makers of the world’s first fully personalized 3D printed braces system, today announced it raised an $80 million Series D round led by Ally Bridge Group. Transformation Capital, and Care CapitalOmega Venture PartnersMatter Venture Partners, and the American Association of Orthodontics also participated in the round, as did existing LightForce investors, including Kleiner PerkinsTyche Partners, and Matrix Partners. With the funding, LightForce will advance its mission to empower orthodontists to deliver personalized care with custom 3D printed brackets by scaling production with a new facility, advancing the use of AI in its workflows, and investing in education.

LightForce, the world’s largest manufacturer of directly 3D printed functional medical devices by volume, provides orthodontists with a comprehensive braces solution that improves treatment efficiency and outcomes for patients. LightForce’s 3D printed hardware is custom-made according to a personalized, digital treatment plan. From Intraoral and CBCT support to final prescription, the LightForce software incorporates powerful AI for generating accurate digital representations of patient anatomy, and optimal teeth positions for clinical efficiency and aesthetics. With the new funding, LightForce will continue to grow its world-leading team of engineers and scientists to further develop its software and hardware to improve patient experience with shorter treatment times and better clinical outcomes. The Series D round will also prepare the company to grow and scale production capabilities, with a new, 36,000 square-foot manufacturing facility in Wilmington, Massachusetts.

Launching commercial operations in 2020, LightForce is changing a nearly century-old approach to braces with 3D printing and AI, enabling a new wave of personalization and efficiency for orthodontists. As LightForce scales production and advances its technology, it plans to address the need for education in the orthodontic industry by investing in clinical education resources that will provide orthodontists with the skills and technology required to transition from stock “one size fits all” braces to a fully digital practice.

“This incredible syndicate of investors brings diverse expertise from the medical device, health IT, AI, and advanced manufacturing sectors to provide critical resources and expert guidance that will support our overall growth and continued innovation,” said LightForce CEO and co-founder Alfred Griffin III, DMD, Ph.D., MMSc. “Teen patients have been limited by the inaccuracy and inefficiency of non-custom braces for decades. LightForce was founded to provide fully personalized treatment options to orthodontists for each of their patients to improve their outcomes and experience while in treatment. With this funding, LightForce will continue to attract key talent, innovate through our incredible community of orthodontists, and scale operations as we seek to elevate the standard of care for teen orthodontic treatment.”

“LightForce is taking the orthodontic industry to the next level,” said Kevin Reilly, Managing Director at Ally Bridge Group. “Their solution applies highly innovative technologies to enable the personalization of orthodontic treatment via 3D printing, helping patients achieve their best smiles. We are excited to be part of a diverse group of top-tier healthcare and tech investors that believe in the benefits of personalized medicine in the orthodontic industry. The future of orthodontics is customization and digital workflow and we are excited to see the continued enhancement in patient care through this funding.”

Each tooth’s shape and every patient’s jaw is as unique as their fingerprints, so no one orthodontic treatment suits all patients. Treatment with traditional one-size-fits-all braces requires the orthodontist to perform multiple wire and bracket adjustments to achieve a patient’s ideal outcome, which can add many months to the treatment time. LightForce’s personalized approach dramatically reduces the need for adjustments, which results in shorter treatment times, fewer appointments, and better outcomes compared to traditional braces. A recent peer-reviewed study in the Journal of Clinical Orthodontics showed that LightForce cases finished 45% faster with 41% fewer scheduled appointments than conventional bracket cases.

About LightForce Orthodontics

LightForce Orthodontics is a digital platform providing orthodontists with fully customized, 3D printed tooth-moving tools. Founded in 2015 by Dr. Alfred Griffin, DMD, PhD, MMSc, along with Dr. Lou Shuman, DMD, CAGS, LightForce is revolutionizing the specialty through advanced manufacturing and technology. After five years of extensive research and development, LightForce launched its first product to the orthodontic market – the world’s first and only fully customized 3D printed bracket system and digital treatment software. Today, LightForce cases are improving the orthodontic experience; a recent peer-reviewed study in the Journal of Clinical Orthodontics showed that LightForce cases finished 45% faster with 41% fewer scheduled appointments than conventional bracket cases. Learn more at https://lf.co/

CG Oncology Announces $105 Million Oversubscribed Crossover Financing to Support Continued Advancement of Clinical-Stage Bladder Cancer Pipeline

Co-led by new investors Foresite Capital and TCGX
Proceeds to advance late-stage clinical programs in bladder cancer towards FDA approval

IRVINE, Calif. (BUSINESSWIRE)–CG Oncology, Inc. today announced the close of an oversubscribed $105 million crossover financing round, co-led by new investors Foresite Capital and TCGX, with participation from Avidity Partners, BVF Partners and Janus Henderson Investors, as well as existing investors including Acorn Bioventures, Ally Bridge Group, Decheng Capital, Longitude Capital, Malin Corporation and RA Capital Management.

“We are excited to welcome leading life science investors who share our vision of developing cutting-edge therapeutics addressing unmet medical needs in bladder cancer,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “Our lead asset, cretostimogene grenadenorepvec, continues to make significant clinical progress in bladder cancer in both monotherapy and in combination studies and we are encouraged to see our treatments get closer to being available to bladder cancer patients worldwide.”

“We have been impressed and encouraged by the significant progress the team at CG Oncology has made to demonstrate the efficacy of oncolytic immunotherapy cretostimogene grenadenorepvec, which has shown clear signals of activity as a single agent and in combination,” said Michael Rome, Ph.D., Managing Director, Foresite Capital. “A significant unmet need remains in bladder cancer, and the CG team is moving with great urgency and focus to deliver potential new treatment options that could elevate the standard of care in this difficult-to-treat patient population.”

The proceeds will support the continued advancement of clinical programs in bladder cancer towards FDA approval including BOND-003, a fully enrolled, single-arm, Phase 3, monotherapy study for cretostimogene grenadenorepvec as a potential treatment for high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

“Cretostimogene grenadenorepvec has the potential to address resistance mechanisms to approved immunotherapies and substantially improve outcomes for bladder cancer patients,” said Giuliano Marostica, Principal, TCGX. “We are excited to partner with CG Oncology to develop this transformational therapy that addresses a high unmet medical need in bladder cancer.”

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO® (nivolumab).

About CG Oncology

CG Oncology is an oncolytic immunotherapy company focused on developing bladder-saving therapeutics for patients with urologic cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative therapies to live and work with dignity and an enhanced quality of life. To learn more, visit: www.cgoncology.com.

Relievant Medsystems Raises $50 Million to Advance the Treatment for Chronic Vertebrogenic Low Back Pain

MINNEAPOLIS, April 19, 2023 (GLOBE NEWSWIRE) —  Relievant Medsystems, a company dedicated to transforming the diagnosis and treatment of vertebrogenic pain, a type of chronic low back pain (CLBP), today announced that it has completed the close of its $50 million Series G financing. The financing was led by new investor Ally Bridge Group with participation from existing investors Endeavour Vision, Vensana Capital, Lightstone Ventures, New Enterprise Associates, Canaan Partners and Morgenthaler Ventures.

“This substantial additional funding allows us to further accelerate our efforts to transform the diagnosis and treatment of vertebrogenic pain,” said Tyler Binney, President and CEO of Relievant Medsystems. “We are thrilled to see strong support from Ally Bridge Group and existing investors in this oversubscribed round as we expand Intracept adoption and make this treatment available to more patients and physicians.”

“We are pleased to join the investor syndicate supporting Relievant,” said Kevin Reilly, a Managing Director at Ally Bridge Group. “We have been impressed by the company’s novel and clinically proven technology and accelerating commercial traction and adoption. We are excited to partner with the company on its journey to provide relief for the millions of patients in the U.S. suffering from chronic low back pain indicated for Relievant’s Intracept Procedure.”

Relievant Medsystems’ minimally invasive Intracept Procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain, using targeted radiofrequency energy to stop the basivertebral nerve (BVN) from transmitting pain signals to the brain. The procedure is typically performed in an outpatient surgery center and takes approximately one hour. Based on existing data, patients usually experience minimal post-procedure pain and generally quick recovery times. Patients often feel pain relief within two weeks of being treated with the Intracept Procedure.

About Vertebrogenic Pain

Of the 30 million people in the U.S. with chronic low back pain, 1 in 6 are likely to have vertebrogenic pain, a distinct type of chronic low back pain caused by damage to vertebral endplates, the interface between the disc and the vertebral body. Patients typically have pain in the middle of their low back, which worsens when they bend over, sit for long periods of time, or when they are active. A physician can confirm a patient’s pain is vertebrogenic by observing Modic changes, a biomarker seen on standard MRI that indicates inflammation at the vertebral endplate.

About Relievant Medsystems

Relievant Medsystems is a commercial-stage medical device company transforming the diagnosis and treatment of vertebrogenic pain, a form of CLBP, with the Intracept Procedure – a novel, clinically proven and commercially available treatment designed to improve the quality of life for millions of indicated patients. For more information about Relievant Medsystems and the Intracept Procedure, visit www.relievant.com.

About Ally Bridge Group

Ally Bridge Group (the “Firm”) is a global healthcare investment management firm focused on high-impact life science innovation across private and public markets. The Firm was founded in 2013 by Frank Yu, Chief Executive Officer and Chief Investment Officer, with its team members based in New York, California, Boston and Hong Kong. Through its scientific and clinical research overlaid with M&A and capital markets expertise, Ally Bridge Group seeks to capture investment opportunities across the capital structure addressing unmet medical needs. For more information, please visit https://ally-bridge.com.

CG Oncology Raises $120 Million in Oversubscribed Series E Financing to Advance Clinical-Stage Urologic Oncology Pipeline

Co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Ally Bridge Group and Sirona Capital
Proceeds to accelerate clinical programs across bladder cancer including in the first-line setting, positioning CG Oncology as the leading urologic oncology company
Brian Liu, M.D., Principal, Longitude Capital to join board of directors

IRVINE, Calif., November 15, 2022  – CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, today announced the close of an oversubscribed $120 million Series E financing round, co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Ally Bridge Group and Sirona Capital. The company has secured a total of over $200 million in funding to date. In connection with the financing, Brian Liu, M.D., Principal from Longitude Capital, will join the company’s board of directors.

The proceeds from the Series E financing will be used to advance the company’s lead clinical programs in bladder cancer towards FDA approval as well as broaden the scope of its pipeline to address unmet medical needs in urologic cancer, such as the first-line setting in Bacillus Calmette-Guérin (BCG)-naïve, Intermediate-Risk non-muscle invasive bladder cancer (NMIBC) patients.

“We are delighted by the support from leading global investors to help us accomplish our mission of developing innovative therapeutics for patients suffering from urologic cancers,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “Our continued clinical progress in bladder cancer is a testament to our lead candidate CG0070 in both monotherapy and combination therapy studies, setting the stage to further expand development across additional urologic oncology indications.”

CG0070 is an intravesically delivered oncolytic immunotherapy agent in an ongoing Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a fully enrolled combination Phase 2 study (CORE1) of CG0070 with anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in the same indication. CG Oncology has a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate the combination of CG0070 with pembrolizumab in CORE1. Interim Phase 2 data for CORE1 announced at the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting on November 10, 2022, continue to show both strong anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG-unresponsive NMIBC.

“We have strong conviction in CG Oncology which continues to generate compelling data to develop potential bladder-sparing innovative therapeutics for patients suffering from bladder cancer,” said Simone Song, Founder and Senior Partner of ORI Capital. “We’ve been strong supporters of the CG Oncology team from an early stage by leading the Series C round, and we are particularly proud to co-lead this round with Longitude Capital and Decheng Capital, as we see tremendous potential for CG0070 to be a game changer for patients with NMIBC.”

“In advanced clinical studies CG0070 has continued to demonstrate potentially transformational results in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population,” said Brian Liu, M.D., Principal, Longitude Capital. “I am excited to join CG Oncology’s board of directors during this significant expansion trajectory for the company and am looking forward to working with the leadership team to bring this therapy to patients in need.”

CG0070 has been administered to over 200 patients for the treatment of bladder cancer. The investigational therapy has exhibited potential best-in-class efficacy and safety in monotherapy as well as strong response rates when combined with checkpoint inhibitors. Given CG0070’s combination results with strong complete response rates in heavily pre-treated BCG-unresponsive, high-risk NMIBC patients, there has been significant demand within the urologic community for CG0070 to also be investigated in the BCG-naïve NMIBC setting, where limited treatment options have been exacerbated by the global BCG shortage impacting both providers and patients. In response, CG Oncology has decided to investigate the activity of CG0070 as a first-line treatment of BCG-naïve, Intermediate-Risk NMIBC in a Phase 2 study to expand clinical development for additional patients with bladder cancer.

About CG0070

Our lead candidate, CG0070, is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. CG0070 is also in a Phase 2 study in combination with KEYTRUDA® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO® (nivolumab).

About CG Oncology

CG Oncology is an oncolytic immunotherapy company focused on developing bladder-saving therapeutics for patients with urologic cancer. At CG Oncology, we see a world where urologic cancer patients can benefit from our innovative therapies to live and work with dignity and an enhanced quality of life. To learn more, visit www.cgoncology.com. Follow us on Twitter @cgoncology.

Ceribell Closes $50 Million Equity Financing Round Led by Ally Bridge Group

Additional financing strengthens Ceribell’s shareholder base and provides capital to support commercial expansion and further development of the company’s first-of-its kind Ceribell Rapid Response EEG System

SUNNYVALE, Calif., September 21, 2022 / Ceribell, Inc. announced today it has closed a $50 million financing round led by new investor Ally Bridge Group, with participation from existing shareholders. The financing was structured as an extension of the company’s previously announced Series C financing.

The Ceribell technology platform is designed to address the need for easier and faster diagnosis in patients with suspicion of seizure. The company will use the combined financing proceeds to support its ongoing commercial expansion across emergency departments and intensive care units. In addition, Ceribell will continue to leverage the power of machine learning and easy EEG accessibility to address other neurological conditions beyond seizure. The company announced receipt of Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA) earlier this month.

“We are excited to partner with Ally Bridge and appreciate the continued support from our existing shareholders,” said Jane Chao, Ph.D., Ceribell’s co-founder and CEO. “Based on our progress to date, it is clear that the Ceribell Rapid EEG system is improving the care quality of seizures in acute care. We look forward to continuing to introduce this novel technology to more ICUs and Emergency Departments, as well as developing diagnostic and monitoring solutions for additional neurological indications impacting the lives of critically ill patients.”

“We are pleased to support Ceribell,” said Charles Chon, Ally Bridge Group Partner. “We have been impressed by the company’s novel technology and commercial traction and are excited to partner with the company on its journey to develop a much needed device and data analytics platform for point of care brain monitoring.”

About Ceribell

Ceribell, Inc. is headquartered in Sunnyvale, CA. Ceribell deploys a cloud-linked, portable electroencephalogram (EEG) device to assess brain waves in minutes to identify the occurrence of seizures and other conditions in emergency rooms and intensive care units. The Ceribell system can be quickly and easily applied to a patient by any healthcare provider and delivers brain monitoring results within minutes. Ceribell is focused on making EEG widely available, more efficient, and more cost-effective to improve the diagnosis and treatment of neurological conditions for patients at risk for seizures. The Ceribell EEG System first received FDA 510(k) clearance in 2017 and is commercially available in the United States.

RayzeBio Propels Forward with $418 Million Raised Since Inception to Advance Targeted Radiopharmaceuticals for Cancer

Series D financing of $160 million co-led by Viking Global Investors, Sofinnova Investments, and Wellington Management
Expands leadership team with appointment of Dr. Abhi Bhat, Ph.D. as SVP, Discovery

RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced a $160 million Series D financing co-led by Viking Global Investors, Sofinnova Investments and Wellington Management. Additional new investors Ally Bridge Group, Sands Capital, Laurion Capital Management, Soleus Capital, and an undisclosed global investor also participated, as did RayzeBio’s current investors. With this financing, RayzeBio has now raised $418 million since beginning operations in August 2020.

“In the last two years, we have transformed from an early start-up to an integrated radiopharmaceutical company leading innovation with this modality to fight cancer. Our lead clinical asset, RYZ101, is poised to be the first Actinium-225 (Ac225) approved drug. In addition, our broad discovery engine has generated several novel drug candidates for clinical evaluation in the near future,” said Ken Song, M.D., President and CEO of RayzeBio. “This financing provides us the ability to further expand our leadership in targeted radiopharmaceuticals and allows us to reach several major value inflection points both clinically and operationally.”

The company’s substantial progress since inception includes:

  • Advancing lead drug candidate, RYZ101, which delivers Ac225, a highly potent alpha-emitting radioisotope, into clinical trials for multiple solid tumor indications. A Phase 1b clinical trial is currently enrolling patients with neuroendocrine tumors and Phase 3 studies could begin as early as 2023. Full details of RayzeBio’s clinical progress are described in a separate press release issued today.
  • Investing in and securing key aspects of commercial scale manufacturing and radioisotope supply.
  • Building a state-of-the-art 28,000 square foot research and development facility in San Diego equipped with the full spectrum of capabilities for radiopharmaceutical drug discovery.
  • Completing more than 200 in vivo studies, thus gaining key proprietary insights to discover novel drug candidates capable of delivering therapeutic radioisotopes to tumor associated antigens.
  • Establishing and entering into a licensing agreement with Ablaze Pharmaceuticals, a biotechnology company that is focused on development and commercialization of radiopharmaceuticals for China.

“RayzeBio has accelerated innovation in the emerging field of targeted radiopharmaceuticals and is breaking ground with Actinium-225 based drugs. We are thrilled to partner with Ken, the management team and board to drive these exciting and potentially game-changing treatments to cancer patients,” said Maha Katabi, Ph.D., Managing Partner at Sofinnova Investments who is joining the RayzeBio Board of Directors in connection with the Series D.

“We continue to follow RayzeBio’s progress and the strength and pace of their execution abilities. We believe that targeted radiopharmaceuticals have significant potential as the next cancer treatment modality and RayzeBio is emerging as an industry leader,” said Irina Margine, Ph.D., Principal at Wellington Management.

In addition to the financing, RayzeBio has appointed Abhi Bhat, Ph.D., as senior vice president, discovery. Abhi has over 20 years of broad cross-functional drug discovery experience spanning bio-conjugates, small molecules, and peptides across multiple therapeutic areas. Most recently, Abhi was the SVP and head of R&D at Design Therapeutics where he delivered the lead clinical asset to treat Friedreich ataxia along with a preclinical pipeline for treating nucleotide repeat disorders.

About RYZ101

RYZ101 is an investigational targeted radiopharmaceutical therapy, designed to deliver a highly potent radioisotope, Actinium-225 (Ac225), to tumors expressing the somatostatin receptor type 2 (SSTR2). RYZ101 is being evaluated in clinical studies for patients with SSTR+ gastroenteropancreatic neuroendocrine tumors who have previously been treated with Lu177-based somatostatin therapies and also in patients with extensive stage small cell lung cancer. Details of the study can be found at https://clinicaltrials.gov/ct2/show/NCT05477576

About RayzeBio

RayzeBio is a biotechnology company focused on improving outcomes for people with cancer by harnessing the power of targeted radioisotopes. With a focus on clinically validated solid tumor targets, RayzeBio is developing novel drug conjugates to deliver potent therapeutic radioisotopes such as Actinium-225, an alpha-emitter. The company is backed by a syndicate of sophisticated healthcare investors and was established in 2020. For additional information, please visit www.rayzebio.com

Finalization of Vifor Pharma acquisition

All regulatory clearances received for the acquisition of Vifor Pharma AG
Settlement of the offer is scheduled for 9 August 2022
Seasoned biopharma executive, Hervé Gisserot, designated to lead the business as General Manager upon settlement of the offer

Melbourne, Australia and St. Gallen, Switzerland, 2 August 2022 CSL Limited (ASX: CSL; USOTC:CSLLY) is pleased to announce it has now received all necessary regulatory clearances for the acquisition of Vifor Pharma AG (Vifor) announced on 14 December 2021.

CSL has set the settlement date of the public tender offer for Vifor for 9 August 2022. If the offer conditions that remain in effect until the settlement remain fulfilled until that date, shareholders who accepted the offer will receive the offer price for each share tendered into the offer on the settlement date, subject to the terms of the offer.

CSL anticipates that it will hold more than 97% of Vifor shares upon the settlement of the offer and intends to have Vifor apply for the delisting of the Vifor Shares after the settlement. Also, CSL has filed an action to cancel the remaining publicly held Vifor Shares in accordance with Swiss takeover rules. The proceedings are currently suspended and will be resumed after the Settlement. Planning for the integration of Vifor is well advanced.

CSL’s Chief Executive Officer and Managing Director, Mr. Paul Perreault said, “We are excited to complete the acquisition of Vifor Pharma – enhancing CSL’s well-established patient focus and ability to protect the health of those facing a range of rare and serious medical conditions. I would like to thank our employees, strategic partners and shareholders who have shown their unwavering support throughout the acquisition process.”

“Joining CSL, the Vifor business adds near-term value along with a clear path to long-term sustainable growth. It also adds an outstanding management team, along with a high-value and complementary portfolio of products and market leading position in the nephrology and iron deficiency spaces.”

“We are pleased about the regulatory clearance for the transaction”, commented Abbas Hussain, Chief Executive Officer of Vifor Pharma. “As we complete the final steps on the CSL acquisition journey, I am full of confidence that Vifor Pharma will have a successful future as part of a larger, global organization. This will allow us to accelerate growth and to successfully drive multiple product launches as we continue to help even more patients around the world live better, healthier lives.”

Appointment of General Manager

CSL also advises Mr. Hervé Gisserot, a demonstrated global leader with diverse biopharma experience, has been designated to lead the Vifor business as General Manager upon settlement of theoffer. He will report to CSL’s Chief Operating Officer, Dr. Paul McKenzie.

Mr. Gisserot is currently the Chief Commercial Officer for Vifor Pharma, joining in January 2022 following 13 years at GlaxoSmithKline where he served in multiple Senior Vice President (SVP) roles, including most recently as SVP & Head of Pharmaceuticals & Vaccines for Greater China & Intercontinental. Prior to that, he held various leadership roles of progressively more responsibility at Sanofi-Aventis, Aventis, Rhone-Poulenc Rorer and Fournier Group.

Dr. McKenzie said: “I’m pleased to welcome Hervé to the role of General Manager. With his proven track record of leading high-performing organizations, executing successful product launches across a number of geographies around the world, and delivering profitable growth, we have confidence in his leadership.”

Due to the closing of the acquisition, the current CEO Abbas Hussain will leave Vifor Pharma in the coming months. Jacques Theurillat, Chairman of the Board of Vifor Pharma, commented: “On behalf of the company, I would like to thank Abbas Hussain for his commitment and leadership during his tenure at Vifor Pharma. We wish him all the best for the future.”

Exemptions from SIX disclosure and publicity obligations

Due to the advanced stage of the acquisition process, SIX Exchange Regulation AG granted Vifor Pharma various exemptions from certain disclosure and publicity obligations in a decision dated 29 July 2022, including an exemption from the obligation to publish a Half-Year Report 2022. These exemptions will take effect upon publication of this ad hoc announcement.

The relevant parts of the decision of SIX Exchange Regulation AG are as follows:

I. Vifor Pharma AG (Issuer) is hereby exempted from the following obligations until the expiry of the period of validity of the Best Price Rule pursuant to Art. 10 para. 1 of the Ordinance of the Swiss Takeover Board of 21 August 2008on Public Takeover Offers (Takeover Ordinance, TOO), until and including 22 September 2022:

a. Publication of the Half-Year Report 2022 (Art. 49 ff. LR in conjunction with art. 10 et seq. Directive on Financial Reporting [DFR] and Directive Regular Reporting Obligations [DRRO]);

b. Publication of ad hoc notices (Art. 53 LR in connection with the Directive on Ad Hoc Publicity [DAH]), with the exception of the publication of an ad hoc notice concerning the announcement of the date of delisting of the Issuer’s registered shares as soon as such date is determined;

c. Disclosure of management transactions (Art. 56 LR);

d. Keeping of the corporate calendar (Art. 52 LR);

e. Fulfillment of the following regular reporting obligations (Art. 55 LR in conjunction with Art. 9 DRRO):

  • para. 1.05 (Change of external auditors),
  • para. 1.06 (Change of balance sheet date),
  • para. 1.08 (4) (Change of weblink to the corporate calendar),
  • para. 1.08 (5) (Change of weblink to the annual reports),
  • para. 2.01 (Filing of annual reports),
  • para. 3.05 (Resolutions regarding opting out/ opting up),
  • para. 3.06 (Changes in connection with restrictions on transferability of shares),
  • para. 5.02 (Reporting of conditional capital).

II. The exemptions pursuant to Section I shall commence with the publication of the ad hoc notice in accordance with the requirements in Section VI.

III. After the expiry of the Best Price Rule on 22 September 2022, the issuer shall be exempted from the obligations pursuant to Section I until 29 October 2022, if and to the extent that none of the following events has occurred by 22 September 2022 or occurs by 29 October 2022:

a. Entry of a minority shareholder or several minority shareholders in the proceedings for cancellation of the issuer’s registered shares pursuant to Art. 137 of the Federal Act on Financial Market Infrastructures and Market Conduct in Securities and Foreign Exchange Trading of 19 June 2015 (Financial Market Infrastructures Act, FMIA) before the competent court;

b. Withdrawal of the action for cancellation of the issuer’s registered shares before the competent court by the plaintiff or by a legal successor;

c. Dismissal of the action for cancellation of the issuer’s registered shares by the competent court;

d. The judgment of the competent court regarding the cancellation of the issuer’s registered shares is upheld.

Should one of the events pursuant to this Clause a. to d. occur before the expiry of the period of validity of the Best Price Rule, the issuer’s obligations pursuant to Section I shall revive immediately after the expiry of the period of validity of the Best Price Rule, i.e. on 23 September 2022.

If one of the events pursuant to this Clause a. to d. occurs after the expiry of the period of validity of the Best Price Rule, i.e. by 29 October 2022, the issuer’s obligations pursuant to Section I shall be revived immediately. In the event of a revival of the obligations pursuant to Section I, the issuer must publish and submit to SIX Exchange Regulation AG the Half-Year Report 2022 within six weeks of the date of the respective revival of the obligations pursuant to Section I (Art. 50 LR in conjunction with Art. 11 et seq. Art. 11 ff. DFR and Art. 9 para. 2.01 (2) DRRO).

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and includes the companies: Vifor Pharma, Sanifit Therapeutics, and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit viforpharma.com

About CSL

CSL (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus- provides life-saving products to more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information visit csl.com.

Legal Disclaimers
Important Additional Information

This release is for informational purposes only and does not constitute, or form part of, any offer or invitation to purchase, sell or issue, or any solicitation of any offer to sell, purchase or subscribe for any registered shares or other equity securities in Vifor Pharma Ltd., nor shall it form the basis of, or be relied on in connection with, any contract therefor. This release is not part of the offer documentation relating to the tender offer. Terms and conditions of the tender offer have been published in CSL’s offer prospectus regarding the tender offer. Shareholders of Vifor Pharma Ltd. are urged to read the tender offer documents, including the offer prospectus, which are or will be available at www.CSLtransaction.com.

Certain Offer Restrictions

The tender offer is not made, directly or indirectly, in any country or jurisdiction in which it would be considered unlawful or otherwise violate any applicable laws or regulations, or which would require CSL or any of its subsidiaries to change or amend the terms or conditions of the tender offer in any material way, to make an additional filing with any governmental, regulatory or other authority or take additional action in relation to the tender offer. It is not intended to extend the tender offer to any such country or jurisdiction. Any documents relating to the tender offer must neither be distributed in any such country or jurisdiction nor be sent into such country or jurisdiction, and must not be used for the purpose of soliciting the sale or purchase of securities of Vifor Pharma Ltd. by any person or entity resident or incorporated in any such country or jurisdiction.

The tender offer is made in the United States pursuant to Section 14(e) of, and Regulation 14E under, the U.S. Securities Exchange Act of 1934, as amended (the “U.S. Exchange Act”), subject to the applicable exemptions provided by Rule 14d-1 under the U.S. Exchange Act and Rule 14e-5(b) under the U.S. Exchange Act and any exemptions that may be granted by the U.S. Securities and Exchange Commission (“SEC”) and otherwise in accordance with the requirements of Swiss law. Accordingly, the tender offer is subject to disclosure and other procedural requirements, including with respect to withdrawal rights, settlement procedures and timing of payments that are different from those applicable under U.S. domestic tender offer procedures and laws. Neither the SEC nor any securities commission of any State of the United States has (a) approved or dis-approved of the tender offer; (b) passed upon the merits or fairness of the tender offer; or (c) passed upon the adequacy or accuracy of the disclosure in the offer prospectus. Any representation to the contrary is a criminal offence in the United States.

The communication is not being made by, and has not been approved by, an “authorised person” for the purposes of Section 21 of the U.K. Financial Services and Markets Act 2000.

Reference is made to the offer prospectus for full offer restrictions.

Other Important Additional Information
Forward-Looking Statements

This announcement may contain statements that constitute forward-looking statements. The words “anticipate”, “believe”, “expect”, “estimate”, “aim”, “project”, “forecast”, “estimate”, “risk”, “likely”, “intend”, “outlook”, “should”, “could”, “would”, “may”, “will”, “continue”, “plan”, “probability”, “indicative”, “seek”, “target”, “plan” and other similar expressions are intended to identify forward-looking statements.

Any such statements, opinions and estimates in this announcement speak only as of the date hereof and are based on assumptions and contingencies subject to change without notice, as are statements about market and industry trends, projections, guidance and estimates. Forward-looking statements are provided as a general guide only. The forward-looking statements in this announcement are not indications, guarantees or predictions of future performance and involve known and unknown risks, uncertainties and other factors, many of which are beyond the control of CSL, its officers, employees, agents and advisors, and may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct, and may cause actual results to differ materially from those expressed or implied in such statements. You are strongly cautioned not to place undue reliance on forward-looking statements.

This announcement is not financial product or investment advice, a recommendation to acquire or sell securities or accounting, legal or tax advice. It does not constitute an invitation or offer to apply for securities. It has been prepared without taking into account the objectives, financial or tax situation or needs of individuals. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial and tax situation and needs and seek legal and taxation advice appropriate for their jurisdiction. CSL is not licensed to provide financial product advice in respect of an investment in securities.

Aerin Medical Secures $60 Million in Equity Financing

Ally Bridge Group joins existing syndicate of KCK MedTech, Questa Capital and OrbiMed.

Sunnyvale, CA – June 16, 2022  Aerin Medical Inc., a company dedicated to providing Ear, Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal conditions, today announced it has recently closed a $60 million equity financing. The financing was led by new investor Ally Bridge Group, with all existing major investors KCK MedTech, Questa Capital and OrbiMed also participating. The company intends to use the proceeds to scale commercialization and expand market access to meet the demand from physicians and their patients.

“Ally Bridge is pleased to lead this financing to accelerate Aerin’s growth, appreciating the company’s highly differentiated strengths in addressing conditions that significantly affect quality of life for millions of patients,” said Frank Yu, founder, CEO and CIO of Ally Bridge Group. “Aerin is well-positioned to continue its strong growth trajectory as a leading innovator in otolaryngology.”

“Since launching VivAer® and RhinAer®, Aerin has been committed to partnering with the otolaryngology community to lay the right foundation for their use—including a dedication to robust clinical data evidenced by 10 new peer-reviewed clinical publications delivered in the last year alone,” said Matt Brokaw, CEO of Aerin Medical. “We appreciate the resulting enthusiastic reception from ENT physicians and their patients, and the commitment from this premier group of private and public healthcare investors.”

The company also announced that Ally Bridge Group managing director Kevin Reilly has joined Aerin Medical’s Board of Directors.

“Ally Bridge Group has a track record of identifying high-impact global healthcare innovations and partnering with the strong teams behind them to accelerate scalable growth,” said Karen Long, Managing Director at KCK MedTech and chairman of Aerin’s Board of Directors. “We’re thrilled to welcome Kevin Reilly and Ally Bridge to our strong syndicate fueling Aerin’s next phase of growth alongside existing partners Questa and OrbiMed.”

VivAer and RhinAer leverage the company’s proprietary temperature-controlled, radiofrequency technology to address two nasal conditions that have limited treatment options but affect sizeable patient populations. VivAer, which launched in the U.S. in 2018, is used to treat nasal obstruction, a condition that affects 20 million Americans.1 RhinAer was launched in the U.S. in 2020 for the treatment of chronic rhinitis.2 More than 60,000 patients have been treated with Aerin Medical products to date. Both non-invasive treatments can be performed in the physician office setting with local anesthetic and are backed by a growing body of evidence supporting their long-lasting efficacy.

About Aerin Medical

Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to provide ENT physicians with non-invasive solutions for the treatment of chronic nasal conditions. The company’s products, VivAer® for nasal airway obstruction and RhinAer® for chronic rhinitis, leverage Aerin Medical’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with in-office procedures performed with local anesthetic. For more information, please visit www.aerinmedical.com and follow Aerin Medical on FacebookTwitterInstagram LinkedIn and YouTube.

1 Value calculated based on 2014 US population estimate from US Census and World Bank data in conjunction with incidence numbers cited in: Stewart M, Ferguson BJ, Fromer L. Epidemiology and burden of nasal congestion. Intl J Gen Med. 2010;3:37-45.
2 Roland LT, et al, The cost of rhinitis in the United States: a national insurance claims analysis. Int Forum Allergy Rhinol. 2021; 11(5):946-948.

 

Castle Biosciences Completes Acquisition of AltheaDx

Acquisition expands Castle’s estimated U.S. TAM by approximately $5.0 billion to $8.0 billion
Castle also announces expanded Medicare coverage for IDgenetix to include seven additional mental health conditions beyond major depressive disorder

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has completed its acquisition of AltheaDx, Inc. (AltheaDx). AltheaDx is a commercial-stage molecular diagnostics company specializing in the field of pharmacogenomics (PGx) testing services that are focused on mental health. IDgenetix®, AltheaDx’s PGx test for mental health conditions, recently received expanded Medicare coverage for the following seven additional mental health conditions beyond major depressive disorder: schizophrenia, bipolar disorder, anxiety disorders, panic disorder, obsessive-compulsive personality disorder, post-traumatic stress disorder and attention deficit hyperactivity disorder.

“Today marks an important milestone in our Castle story as we welcome the talented AltheaDx team to our Castle family and IDgenetix to our portfolio of innovative tests,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We believe there is great potential in IDgenetix and PGx testing to improve the care of patients suffering from mental health conditions through personalized, genetic-based treatment plans that offer hope for faster and improved response to prescription medications.

“Additionally, the recent expansion of Medicare coverage for IDgenetix to include seven additional mental health conditions beyond major depressive disorder provides us with an enhanced opportunity to help patients affected by these conditions.”

Transaction Terms and Other Information

Under the terms of the definitive agreement, AltheaDx became a wholly owned subsidiary of Castle Biosciences. At closing, $65.0 million in initial consideration was payable by Castle to AltheaDx security holders, which consisted of $32.5 million in cash, subject to adjustments for cash, debt, transaction expenses and working capital, and $32.5 million in common stock of Castle. Further, up to an additional $75.0 million in cash and common stock will be payable in connection with the achievement of certain milestones based on 2022, 2023 and 2024 performance and expanded Medicare coverage for IDgenetix.

About IDgenetix®

IDgenetix® is a pharmacogenomic (PGx) test for depression, anxiety and other mental health conditions designed to analyze a patient’s genetic make-up to guide timely and evidence-based decisions on the optimal drug for each patient. IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard of care trial-and-error approach. IDgenetix provides drug-drug and drug-gene interactions and is supported by a published, peer-reviewed randomized controlled trial that demonstrated clinical utility over the standard of care when physicians used IDgenetix prior to prescribing a medication.1 IDgenetix is currently reimbursed by Medicare for the following eight mental health conditions: major depressive disorder, schizophrenia, bipolar disorder, anxiety disorders, panic disorder, obsessive-compulsive personality disorder, post-traumatic stress disorder and attention deficit hyperactivity disorder.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedInFacebookTwitter and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, myPath Melanoma, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: our estimated U.S. TAM for IDgenetix following our acquisition of AltheaDx; the potential improvements in the care of patients suffering from mental health conditions through personalized, genetic-based treatment plans incorporating IDgenetix and PGx testing; the hope for faster and improved response to prescription medications offered by such treatment plans; the enhanced market opportunity provided by the recent expanded Medicare coverage for IDgenetix; and the potential for IDgenetix to help patients achieve a faster therapeutic response and improve their chances of remission.. The words “believes,” “estimates,” “expects,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: risks associated with business combination transactions, such as the risk that acquired businesses will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; the calculations of, and factors that may impact the calculations of, the estimated U.S. TAM for IDgenetix, which may prove to be inaccurate; risks related to future opportunities and plans for our company following our acquisition of AltheaDx, including uncertainty of our expected financial performance and results of our company following completion of the acquisition; disruption from the acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; changes in market conditions and the introduction of competitive technologies, as well as competition from other commercial-stage diagnostics companies with PGx offerings for the treatment of depression, anxiety or other mental health conditions; the impact of unanticipated regulatory obligations and oversight; our expectations regarding reimbursement for IDgenetix or tests currently in our commercial portfolio; our ability to integrate AltheaDx’ technology and tests into our commercial offerings; the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business; subsequent study or trial results and findings may contradict earlier study results and findings, including with respect to the IDgenetix PGx test discussed in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2021, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

1Bradley et al. Journal of Psychiatric Research. 2018 Jan; 96:100-107; doi: 10.1016/j.jpsychires.2017.09.024