Day: September 20, 2021

New Data Supporting Potential of ADG20 for Both the Treatment and Prevention of COVID-19 to be Presented at IDWeek 2021

Patient Population in Global EVADE Phase 2/3 Clinical Trial of ADG20 Expanded following IDMC Assessment

$355.8 Million IPO Completed to Fund Continued Advancement of Portfolio of Antibody-based Solutions for Infectious Diseases with Pandemic Potential

WALTHAM, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today reported updates on its lead COVID-19 antibody program, ADG20, as well as recent business highlights and second quarter 2021 financial results.

“Across the globe, COVID-19 continues to be a significant health crisis affecting nearly every age group. With the continued emergence of new variants, broadly neutralizing therapies that can be used for both the treatment and prevention of the disease are critical to address the current endemic as well as potential future outbreaks,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. “Our team is working closely with our global CRO partners on the execution of our ongoing global clinical trials of ADG20, STAMP and EVADE, while also preparing for the anticipated worldwide commercialization of ADG20, if approved.

“ADG20 is a highly differentiated antibody that we are advancing through pivotal trials for both the treatment and prevention of COVID-19. We are pleased by the recent assessment of unblinded data by the IDMC for the EVADE trial, and their support of our plans to expand enrollment to include adolescents and pregnant or nursing women,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “To date, we have generated a compelling data package for ADG20 that includes broad neutralization of the original SARS-CoV-2 virus and the known variants of concerns in in vitro models as well as a favorable pharmacokinetic and tolerability profile in our Phase 1 trial. Further, at this year’s IDWeek, we will release additional data from our Phase 1 trial as well as details regarding our dose selection process for treatment and prevention, which we believe further support the important role this novel antibody can play in combatting the ongoing pandemic.”

ADG20 COVID-19 Program Highlights

• New ADG20 Data to be Presented in Multiple Posters during IDWeek: At the IDWeek 2021 Virtual Conference, Adagio plans to present additional data highlighting the potential for ADG20 to provide protection from COVID-19 for up to one year based on its extended half-life in humans combined with its broad and potent neutralizing ability demonstrated in laboratory testing. In addition, the data support the evaluation of a 300mg dose, delivered as a single intramuscular injection, in the ongoing Phase 2/3 STAMP (treatment) and EVADE (prevention) global clinical trials. The data will be presented in multiple posters, which will be available to registered attendees on the virtual platform throughout the duration of the conference, being held from September 29 – October 3, 2021. The presentations include:
  • 1086: A Whole-Body Quantitative System Pharmacology Physicologically-Based Pharmacokinetic (QSP/PBPK) Model that a priori Predicts Intramuscular (IM) Pharmacokinetics of ADG20: an Extended Half-life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
  • 633: Preliminary Results from a Phase 1 Single Ascending-Dose Study Assessing Safety, Serum Viral Neutralizing Antibody Titers (sVNA), and Pharmacokinetic (PK) Profile of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
  • 1089: Use of a Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Prevention of Coronavirus Disease (COVID-19)
  • 1088: A Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment of Coronavirus Disease (COVID-19)
• Patient Population Expanded in EVADE following IDMC Data Assessment: The independent data monitoring committee (IDMC) for the EVADE Phase 2/3 trial of ADG20 for the prevention of COVID-19 recently provided a recommendation to expand Phase 3 trial enrollment to include adolescents 12 years and older and pregnant or nursing women, as well as a decrease in the protocol-specified, in-clinic post injection monitoring time. The IDMC’s recommendations were based on their review of unblinded safety and tolerability data through the Day 28 post-treatment visit from 200 participants enrolled in the Phase 2 lead-in portion of the trial.
• Partnership with Biocon Biologics Expands the Reach of a Potent and Broadly Neutralizing COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets: In the second quarter of 2021, Adagio partnered with Biocon Biologics Ltd. to combat the ongoing COVID-19 crisis in southern Asia. The partnership provides Biocon rights to manufacture and commercialize an antibody therapy based on ADG20 in India and additional select emerging markets based on the commercial manufacturing process developed for ADG20. As part of the agreement, Biocon will be granted access to data from Adagio’s Phase 2/3 clinical trials as well as its anticipated Emergency Use Authorization package and other regulatory submissions to support approval or emergency authorization in India and other select emerging markets.

Recent Business Highlights

• David Hering, Global COVID-19 Vaccine Expert, Appointed as Chief Operating Officer: Adagio recently appointed David Hering as the company’s chief operating officer. Mr. Hering joins Adagio from Pfizer, where he most recently served as the global mRNA business lead, a business specifically created to manage global COVID-19 efforts as well as future vaccines utilizing mRNA technology, and led the launch of the first-ever COVID-19 vaccine in the United States. Prior to his most recent role at Pfizer, Mr. Hering was president, North America at Pfizer, where he led a 700-person organization across a portfolio of vaccine products for COVID-19 and meningococcal and pneumococcal diseases.
• $355.8 Million Initial Public Offering (IPO) Successfully Completed: In August 2021, Adagio sold 20,930,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,730,000 shares of common stock at a public offering price of $17.00 per share. The gross proceeds of the offering, before underwriting discounts and commissions and other offering expenses payable by Adagio, were approximately $355.8 million.
• Collaboration with Scripps: Adagio entered into an exclusive research agreement with The Scripps Research Institute to identify broadly protective vaccine candidates for the prevention of influenza and beta coronaviruses.
• Board of Directors Expanded with Industry Leaders to Support Future Growth: Adagio recently announced appointments of three industry veterans and area experts to its board of directors:
  • Tom Heyman, former president of the Johnson & Johnson Development Corporation (JJDC);
  • Anand Shah, M.D., former deputy commissioner for medical and scientific affairs at the U.S. Food and Drug Administration (FDA); and
  • Michael S. Wyzga, president of MSW Consulting, Inc. and former CFO of Genzyme

Second Quarter 2021 Financial Results

• As of June 30, 2021, Adagio had cash, cash equivalents and marketable securities of $392.5 million, which includes net proceeds from its Series C financing completed in April. Pro forma cash, cash equivalents and marketable securities as of June 30, 2021 is $719.6 million after giving effect to our initial public offering which closed on August 10, 2021.
• Research & development expenses including in-process research and development for the second quarter of 2021 were $37.6 million.
• Selling, general & administrative expenses for the second quarter of 2021 were $7.1 million.
• Net Loss for the second quarter was $44.7 million, or $0.18 per share.

About ADG20
ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is administered by a single intramuscular injection, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.

About Adagio Therapeutics

Adagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. For more information, please visit www.adagiotx.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned IND submissions, initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. 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. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, those risks described under the heading “Risk Factors” in Adagio’s prospectus filed with the Securities and Exchange Commission (“SEC”) on August 6, 2021 and in Adagio’s future reports to be filed with the SEC, including Adagio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

Contacts:

Media Contact:
Dan Budwick, 1AB
Dan@1abmedia.com

Investor Contact:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except share and per share amounts)

		June 30, 2021				December 31, 2020
Assets
Current assets:
Cash and cash equivalents(1)		$	392,509			$	114,988
Prepaid expenses and other current assets			3,550				2,394
Total current assets			396,059				117,382
Deferred offering costs			1,933				—
Total assets		$	397,992			$	117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable		$	10,716			$	8,153
Accrued expenses			27,181				4,919
Total current liabilities			37,897				13,072
Early-exercise liability			8				11
Total liabilities			37,905				13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C) $0.0001 par value; 16,944,484 shares authorized, issued and outstanding at June 30, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $505,399 and $169,900 at June 30, 2021 and December 31, 2020, respectively			504,711				169,548
Stockholders’ deficit:
Common stock, $0.0001 par value; 150,000,000 shares authorized at June 30, 2021 and December 31, 2020; 5,599,240 shares issued and outstanding at June 30, 2021; 28,193,240 shares issued and 5,593,240 shares outstanding at December 31, 2020			1				1
Treasury stock, at cost; 0 shares and 22,600,000 shares at June 30, 2021 and December 31, 2020, respectively			—				(85	)
Additional paid-in capital			4,067				154
Accumulated deficit			(148,692	)			(65,319	)
Total stockholders’ deficit			(144,624	)			(65,249	)
Total liabilities, convertible preferred stock and stockholders’ deficit		$	397,992			$	117,382

(1)     Pro forma cash, cash equivalents and marketable securities as of June 30, 2021 is $719.6 million after giving effect to our issuance and sale of 20,930,000 shares of our common stock in our initial public offering at the price of $17.00 per share after deducting underwriting discounts, commissions and estimated offering costs which closed on August 10, 2021.

ADAGIO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

(In thousands, except share and per share amounts)

		Three Months Ended June 30,				Six Months Ended June 30,				Period from June 3, 2020 (Inception) to June 30,
		2021				2021				2020 (3)
Operating expenses:
Research and development(1)		$	35,067			$	69,204			$	48
Acquired in-process research and development(2)			2,500				3,500				—
Selling, general and administrative			7,124				10,695				50
Total operating expenses			44,691				83,399				98
Loss from operations			(44,691	)			(83,399	)			(98	)
Other income (expense):
Interest income			23				32				—
Other expense			(5	)			(6	)			—
Total other income (expense), net			18				26				—
Net loss and comprehensive loss		$	(44,673	)		$	(83,373	)		$	(98	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.18	)		$	(0.66	)		$	—
Weighted-average common shares outstanding, basic and diluted			249,769				125,574				21,250,000

(1)   Includes related-party amounts of $247 for the three months ended June 30, 2021, $435 for the six months ended June 30, 2021 and $0 for the period from June 3, 2020 (inception) to June 30, 2020.
(2)   Includes related-party amounts of $2,500 for the three months ended June 30, 2021, $3,500 for the six months ended June 30, 2021 and $0 for the period from June 3, 2020 (inception) to June 30, 2020.
(3)   The results for the period from June 3, 2020 (inception) to June 30, 2020 are the same for the three and six months ended June 30, 2020.

FDA Clears First Technology to Distinguish between Bacterial and Viral Infections Using the Body’s Immune Response – The MeMed BV® Test and MeMed Key® Platform

• MeMed BV is a first-of-its kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes
• MeMed Key is a pioneering platform that enables rapid and sensitive measurements of multiple proteins at the point-of-need
• The MeMed technology suite enables better informed antibiotic treatment decisions, an essential tool in the fight against the global threat of resistant bacteria

HAIFA, Israel, Boston, MA; September 20th, 2021 – MeMed, a leader in the emerging field of advanced host-response technologies, today announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the MeMed BV® test on the point-of-need platform MeMed Key® to help healthcare providers distinguish between bacterial and viral infections. The technology has been cleared for both children and adults.

Bacterial and viral infections are often clinically indistinguishable, leading to the prescription of antibiotics for the treatment of viral infections, for which they are ineffective. Antibiotic misuse drives the emergence of antimicrobial resistance (AMR), one of the biggest healthcare challenges of our time.
The novelty of MeMed’s technology is that it decodes the body’s immune response to infection, the ‘host response’, rather than focusing on detecting the presence of a microbe. This allows robust diagnosis when the infection site is inaccessible or unknown, even when the pathogen is undetectable using conventional tests, or when the cause of infection are emerging new pathogens. It enables better informed antibiotic treatment decisions, an essential tool in the fight against resistant bacteria.

“For those of us who care for acutely ill children, we have been waiting decades for accurate, rapid diagnostics to confidently guide the care of moderately ill children without a clear focus of infection or recognizable viral illness. This novel test offers promise to help differentiate those children with self-limited viral illness from those with possible bacterial infection, thereby supporting the judicious use of antibiotics,” said Rich Bachur, MD, Professor of Pediatrics and Emergency Medicine, Harvard Medical School, and Chief, Division of Emergency Medicine, Boston Children’s Hospital.

“It has been a decade long journey to reach this point from concept to impacting patient lives,” said Dr. Eran Eden, MeMed’s co-founder and CEO. “This FDA clearance is a breakthrough moment in the field of advanced host-response and could not have been achieved without the dedication of the MeMed team, our clinical partners in the US and around the globe, and the support of the US Department of Defense and EU Commission.”

Sergey Motov, MD, Professor of Emergency Medicine, Maimonides Medical Center, New York, said: “Host-response technologies are a new frontier in the management of patients with infectious diseases, with great potential to improve patient outcomes. Every day, I see adults with a complicated medical history presenting to the emergency room with a suspected respiratory tract infection. A technology like MeMed BV can significantly aid in their management.”

“We are now using MeMed BV in my department routinely to aid in determining whether a child with fever has a bacterial or viral infection. For example, we recently had a complicated case of a young child with fever but without a clear source. MeMed BV helped in early identification of a severe bacterial infection, that would otherwise be masked by viral PCR detection, lead to a change in the course of treatment, and made a big difference in the patient’s outcome,” said Dr Adi Klein, Director of the Pediatric Division, Hillel Yaffe Medical Center and Head of the Israeli Clinical Pediatric Society. “Introducing MeMed’s technology has had a significant impact on our medical practice, enabling us to be better stewards of antibiotics and improving patient outcomes.”

FDA clearance was based on a multi-center blinded clinical validation study enrolling over 1,000 children and adults and addresses goals laid out in the US National Action Plan for Combating Antibiotic Resistant Bacteria. The test provides highly accurate results with Area Under the Curve of 90% and 97% (primary and secondary endpoints). MeMed has established its US base in Boston and is ramping up commercial activities to ensure broad availability of its products across the US.

About MeMed
Our mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. To learn more about MeMed and our solutions, please visit http://www.me-med.com

About MeMed BV®
MeMed BV® is a first-of-its-kind immune-based protein signature test, developed and validated over the course of decade-long collaborations with leading academic and commercial partners. It provides physicians with an indispensable tool to help distinguish between bacterial and viral infections across multiple pathogens, even if the infection site is inaccessible or unknown. MeMed BV® measures and computationally integrates the levels of three immune system proteins: TRAIL, IP-10 and CRP. When run on the MeMed Key® platform, MeMed BV® provides a result within 15 minutes. MeMed BV® has been independently validated on thousands of patients and the results have been published in leading peer-reviewed journals (including Pediatrics, The Lancet ID,  PLOS One, BMJ Peds and European Journal of Clinical Microbiology & Infectious Diseases). The MeMed BV® test has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.

About MeMed Key®
MeMed Key® is a pioneering technology platform, enabling highly sensitive measurements of multiple proteins, within minutes, at the point of need. It opens the way to quantification of a vast array of human proteins in healthy and disease states, where and when it actually matters. The MeMed Key® development program has been partially funded by the US Department of Defense and the EU Commission. MeMed Key® has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.

MeMed Contacts:
Adee Mor, VP Marketing, MeMed
pr@me-med.com
Kfir Emmer, CFO, MeMed
kfir.emmer@me-med.com

Media relations contact:
Consilium Strategic Communications MeMed@consilium-comms.com

Please click here to see the full release in Hebrew

JEITO CAPITAL BECOMES A KEY PLAYER IN THE FINANCING
OF LIFE SCIENCES IN EUROPE WITH THE CLOSING OF JEITO I
AT €534 MILLION ($630 MILLION)

Jeito I exceeds target and becomes the largest European fund dedicated
to the life sciences sector

Jeito Capital is dedicated to working with biotech entrepreneurs to provide
financial and expert support in continuity to accelerate patients’ access
to groundbreaking therapies

Paris, September 20, 2021 – Jeito Capital, a rapidly growing, new, independent Private Equity firm dedicated to biotech and biopharma, today announced the final closing of its first fund, Jeito I, at €534 million ($630 million), exceeding its original target of €500 million. Jeito I is the largest European fund dedicated to supporting companies in the life sciences sector.

Jeito Capital is building a strong and diversified portfolio of biotech and biopharma companies primarily based in Europe with global reach, focused on the treatment of life-threatening diseases. Jeito’s unique investment model provides support to entrepreneurs by a multi-talented team of experts integrated in the investment team across the entire drug development value chain, from translational science to market access and commercialization, providing significant capital in continuity, up to €80 million ($100 million) in a single company.

Jeito I investments to date include French-based SparingVision and InnoSkel, in the fields of genomic ophthalmology and rare skeletal disorders, respectively, Dutch biotech Neogene Therapeutics in solid tumors, UK-based Pulmocide in severe respiratory diseases, and Swiss-French Alentis Therapeutics in fibrosis and related cancers.

Jeito I attracted leading global investors including the European Investment Fund (EIF), the American pension fund Teacher Retirement System of Texas (TRS), which has made its first-ever investment into a European fund dedicated to the biotech sector, and Temasek, a global investor headquartered in Singapore with deep experience investing in life sciences.

Founded and directed by Dr Rafaèle Tordjman, MD PhD, Jeito Capital was launched in January 2020 and completed a first funding round of €200 million with the strategic support of investors such as Aviva, AXA, the French public investment bank (BPI), BNP Paribas Fortis, the Caisse des Dépôts et des Consignations (CDC), CNP Assurances, Pro BTP, etc. In the following months Sanofi selected Jeito as its first ever investment into a private French-based fund, investing €50 million.

Rafaèle Tordjman, Founder and CEO of Jeito Capital, said: “We are extremely proud to have closed Jeito I, making it the largest European fund dedicated to the life sciences sector. We have thus exceeded our original target and have attracted a group of leading and diverse global investors, a testament to Jeito’s unique investment model and team. I am pleased to welcome new investors including the EIF, TRS and Temasek and would like to thank our existing investors for their unwavering support. This important achievement will enable Jeito to fulfill its mission: to provide continuous financial support and industry expertise to talented entrepreneurs to accelerate the development of revolutionary therapies and guaranteeing patients quicker access to medical innovations.”

Sabine Dandiguian, Managing Partner of Jeito Capital, added: “This exceptional fundraising success confirms Jeito’s investment model driven by Rafaèle Tordjman. I am very proud to have been part of this multi-talented team since the very beginning which, thanks to its expertise across all stages of company development, is able to uncover and support the best scientific quality start–ups in Europe, with a global reach. Thanks to Jeito’s dynamic and collaborative team we have already developed a pipeline of high-quality deal flow. We look forward to achieving our shared ambitions and making a significant and meaningful difference to patients’ lives.”

Currency converter: €1 = USD$1.18 as of 14 September 2021

About Jeito Capital
Jeito Capital is a global leading investment company with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports entrepreneurs through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access in Europe & the United States. Jeito Capital has €534 million under management. Jeito Capital is based in Paris with a presence in Europe and the United States. For more information, please visit www.jeito.life, or follow on Twitter @Jeito_life or LinkedIn.

For more information please contact:

Jeito Capital Rafaèle Tordjman, Founder and CEO contact@jeito.life Assistant : Marine Beigneux marine@jeito.life Consilium Strategic Communications (international PR) Mary-Jane Elliott / Melissa Gardiner / Davide Salvi/ Kris Lam Jeito@consilium-comms.com Tilder (French PR) Marion Bougeard m.bougeard@tilder.com

Tel: +33 6 35 36 35 00 Tel: +44 (0) 20 3709 5700 Tel: +33 (0) 6 76 73 57 31

 

Please click here to see the full release in French