Market Newsdesk

MONTREAL, May 08, 2023 (GLOBE NEWSWIRE) — Osisko Development Corp. (NYSE: ODV, TSXV: ODV) (“Osisko Development” or the “Company“) is pleased to announce the signing of two landmark permitting agreements, the Process Charter and the Joint Information Requirements Table (the “IRT“), reaffirming the multilateral support of and commitment by the various levels of the Government of British Columbia (“BC“) to advance the approval process of the Company’s 100%-owned Cariboo Gold Project (“Cariboo” or the “Project“) located in central BC, Canada.

Sean Roosen, Chairman and CEO, commented, “We are very pleased with the signing of these two unique agreements, which establish clear timelines for review and referral of Cariboo’s permit applications, as well as set out a defined framework for information requests. They provide the Company with predictability and key mechanisms to successfully navigate the regulatory permitting process. The progress achieved to date continues to showcase our strong partnership with the Government of BC and demonstrates the commitment from all parties to advance Cariboo’s permitting. We look forward to continuing our work efforts in close collaboration with all levels of Government, stakeholders, Indigenous partners and local communities.“

• The Process Charter, signed with the BC Major Mines Office (the “MMO“), establishes a workplan for cooperation between the Company, the MMO, the Ministry of Energy, the Mines and Low-Carbon Innovation (“EMLI“) and the Ministry of Environment (“ENV“) and commits all parties to a defined regulatory permitting process timeline as it relates to the Project. The target timelines established by the Process Charter, which are contingent on the issuance of the Environmental Assessment Certificate anticipated in Q3 2023, contemplate a final application referral date that is aligned with the Company’s anticipated receipt of environmental permits in Q1 2024.
• The Joint Information Requirements Table, signed with the EMLI and the ENV, outlines and serves as a single list of all agreed upon information requirements to support the Project’s Mines Act and the Environmental Management Act permit applications, issued by EMLI and ENV, respectively. The unique IRT for Cariboo assists all parties in developing a robust permit application for submission, and may result in additional information requests, subject to the application review process.

Lhtako Dené Nation noted,
“We truly believe that the mining industry and the Lhtako Dené Nation can work together as a team and continue to make our relationship stronger than yesterday. We are encouraged by Osisko Development’s commitment to building a sustainable and environmentally innovative operation and look forward to continuing working together. The Project will not only provide the Nation and local communities with long-term employment, support and opportunity, but will also bring our Nation and local communities together.”

The Company has also executed several project electrification initiatives in partnership with BC Hydro’s CleanBC Industry Fund and the CleanBC Facilities Electrification Fund, which are important steps in supporting the Company’s efforts in reducing the carbon footprint of the Project. One of the grants provides for up to a $2.5 million rebate to the Company upon completion of the Barlow substation connection, near Quesnel, BC.

About


Osisko


Development


Corp.

Osisko Development Corp. is a premier North American gold development company focused on high-quality past-producing properties located in mining friendly jurisdictions with district scale potential. The Company’s objective is to become an intermediate gold producer by advancing its 100%-owned Cariboo Gold Project, located in central B.C., Canada, the Tintic Project in the historic East Tintic mining district in Utah, U.S.A., and the San Antonio Gold Project in Sonora, Mexico. In addition to considerable brownfield exploration potential of these properties, that benefit from significant historical mining data, existing infrastructure and access to skilled labour, the Company’s project pipeline is complemented by other prospective exploration properties. The Company’s strategy is to develop attractive, long-life, socially and environmentally sustainable mining assets, while minimizing exposure to development risk and growing mineral resources.

For further information, please contact Osisko Development Corp.:

Sean Roosen	Philip Rabenok
Chairman and CEO	Director, Investor Relations
Email: [email protected]	Email: [email protected]
Tel: +1 (514) 940-0685	Tel: +1 (437) 423-3644

CAUTION REGARDING FORWARD LOOKING STATEMENTS

Certain statements contained in this news release may be deemed “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities legislation. These forward
‐
looking statements, by their nature, require Osisko Development to make certain assumptions and necessarily involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these forward
‐
looking statements. Forward
‐
looking statements are not guarantees of performance. Words such as “may”, “will”, “would”, “could”, “expect”, “believe”, “plan”, “anticipate”, “intend”, “estimate”, “continue”, or the negative or comparable terminology, as well as terms usually used in the future and the conditional, are intended to identify forward
‐
looking statements. Information contained in forward
‐
looking statements is based upon certain material assumptions that were applied in drawing a conclusion or making a forecast or projection, including the permitting, environmental and closure expectations (timing and if at all); steps required to obtain an Environmental Assessment Certificate (timing and if at all); expectations regarding multilateral support of and commitment by various levels of the Government of BC to advance the approval process of the Project; timing expectations for review and referral of Cariboo’s permit applications; cooperation of stakeholders, community and partners; management’s perceptions of historical trends, current conditions and expected future developments; the utility and significance of historic data, including the significance of the district hosting past producing mines; future mining activities; the robust and production scale at Cariboo; the potential of high grade gold mineralization on Cariboo; the results (if any) of further exploration work to define and expand mineral resources; the ability of exploration work (including drilling) to accurately predict mineralization; the ability to generate additional drill targets; the ability of management to understand the geology and potential of the Company’s properties; the ability of the Company to expand mineral resources beyond current mineral resource estimates; the ability of the Company to complete its exploration objectives for its projects in 2023 in the timing contemplated (if at all); the ongoing advancement of the deposits on the Company’s properties; the deposit remaining open for expansion at depth and down plunge; the ability to realize upon any mineralization in a manner that is economic; the Cariboo project design and ability and timing to complete infrastructure at Cariboo (if at all); the ability and timing for Cariboo to reach commercial production (if at all); the ability to adapt to changes in gold prices, estimates of costs, estimates of planned exploration and development expenditures; the ability of the Company to obtain further capital on reasonable terms; the profitability (if at all) of the Company’s operations; the Company being a well-positioned gold development company in Canada, USA and Mexico; sustainability and environmental impacts of operations at the Company’s properties; as well as other considerations that are believed to be appropriate in the circumstances, and any other information herein that is not a historical fact may be “forward looking information”. Material assumptions also include, management’s perceptions of historical trends, the ability of exploration (including drilling) to accurately predict mineralization, budget constraints and access to capital on terms acceptable to the Company, current conditions and expected future developments, results of further exploration work to define or expand any mineral resources, as well as other considerations that are believed to be appropriate in the circumstances. Osisko Development considers its assumptions to be reasonable based on information currently available, but cautions the reader that their assumptions regarding future events, many of which are beyond the control of Osisko Development, may ultimately prove to be incorrect since they are subject to risks and uncertainties that affect Osisko Development and its business. Such risks and uncertainties include, among others, risks relating to capital market conditions and the Company’s ability to access capital on terms acceptable to the Company for the contemplated exploration and development at the Company’s properties; the ability to continue current operations and exploration; regulatory framework, First Nations and community support, and presence of laws and regulations that may impose restrictions on mining; the ability of exploration activities (including drill results) to accurately predict mineralization; errors in management’s geological modelling; the ability to expand operations or complete further exploration activities; the timing and ability of the Company to obtain required approvals and permits; the results of exploration activities; risks relating to exploration, development and mining activities; the global economic climate; metal and commodity prices; fluctuations in the currency markets; dilution; environmental risks; and community, non-governmental and governmental actions and the impact of stakeholder actions. Readers are urged to consult the disclosure provided under the heading “Risk Factors” in the Company’s annual information form for the year ended December 31, 2022 as well as the Financial Statements and MD&A which have been filed on SEDAR (www.sedar.com) under Osisko Development’s issuer profile and on the SEC’s EDGAR website (www.sec.gov), for further information regarding the risks and other factors applicable to the exploration results. Although the Company’s believes the expectations conveyed by the forward-looking statements are reasonable based on information available as of the date hereof, no assurances can be given as to future results, levels of activity and achievements. The Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise, except as required by law. Forward-looking statements are not guarantees of performance and there can be no assurance that these forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

NEW HAVEN, Conn. and NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced they will present updated data related to vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. Vepdegestrant is a novel investigational PROTAC^® estrogen receptor (ER) protein degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Four posters will be presented during the poster session at the annual congress, which will be held from May 11-13, 2023, in Berlin, Germany.

Poster session details are as follows:

Date: Friday, May 12, 2023
Time: 12:15 – 1:00 p.m. CET/ 6:15 – 7:00 a.m. ET

• VERITAC update: phase 2 study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer (Poster 205P)
• VERITAC-2: a global, randomized phase 3 study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, vs fulvestrant in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer (Poster 257TiP)
• TACTIVE-N: open-label, randomized, noncomparative neoadjuvant phase 2 study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, or anastrozole in postmenopausal women with ER+/human epidermal growth factor receptor 2 (HER2)- localized breast cancer (Poster 154TiP)
• TACTIVE-E: phase 1b study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with everolimus in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer (Poster 256TiP)

For more information, visit the official ESMO Breast Cancer Annual Congress website here.

About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC^® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.

In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

About Arvinas

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC^® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC^® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC^® protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs in development: bavdegalutamide and ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and vepdegestrant (ARV-471) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. For more information, visit www.arvinas.com.

Arvinas Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential benefits of our arrangements with our collaborative partnership with Pfizer, the development and regulatory status of our product candidates, such as statements with respect to our lead product candidates, ARV-110, ARV-471 and ARV-766 and other candidates in our pipeline, and the timing of clinical trials and data from those trials and plans for registration for our product candidates, and our discovery programs that may lead to our development of additional product candidates, the potential utility of our technology and therapeutic potential of our product candidates, the potential commercialization of any of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” 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 we make as a result of various risks and uncertainties, including but not limited to: whether we and Pfizer will be able to successfully conduct and complete clinical development for ARV-471, whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-766, initiate and complete other clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all and other important factors discussed in the “Risk Factors” sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice:

The information contained in this release is as of May 8, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about vepdegestrant (ARV-471) and a global collaboration between Pfizer and Arvinas to develop and commercialize ARV-471, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any applications may be filed for ARV-471 for any potential indications in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for ARV-471 in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether ARV-471 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ARV-471; whether the collaboration between Pfizer and Arvinas will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Arvinas Media Contacts

Investor Contact:
Jeff Boyle, Arvinas Investor Relations
347-247-5089
[email protected]

Media Contact:
Kirsten Owens, Arvinas Communications
203-584-0307
[email protected]

Pfizer Media Contacts

Investor Contact:
+1 (212) 733-4848
[email protected]

Media Contact:
+1 (212) 733-1226
[email protected]

SAN DIEGO and GAINESVILLE, Ga., May 08, 2023 (GLOBE NEWSWIRE) — Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract development and manufacturing organization (CDMO), today announced that it has been selected by Xequel Bio, Inc. (“Xequel”) to provide CDMO services to support the ongoing clinical development of a patented new chemical entity based on its aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) platform. The agreement spans a range of Societal CDMO’s offerings including process development and clinical trial services, culminating in cGMP manufacturing of the compound and placebo for upcoming Phase 2 clinical trials of iNexin™ (aCT1 ophthalmic solution). iNexin is a sterile, preservative-free ophthalmic solution containing aCT1 peptide that is currently being evaluated by Xequel for the potential treatment of persistent corneal epithelial defects (PCED).

“We are pleased to have been selected by Xequel to continue our support of this important investigational drug candidate in the ophthalmology space. It is gratifying to be able to grow this relationship in lockstep with the advancement of iNexin into the next phase of its clinical development, demonstrating our ability to meet the evolving needs of our customers as they mature their development pipelines,” said David Enloe, chief executive officer of Societal CDMO. “This new agreement is the latest highlight in what has been an active period for our business development, project management, and operations teams. In just the past six weeks, we have announced new customer agreements with Longboard Pharmaceuticals and Xequel, project expansion agreements with several existing customers, and an approval from FDA for manufacturing of a commercial tablet at our Georgia facility. We continue to deliver against our growth strategy and look forward to maintaining the momentum as we move through 2023.”

About Societal CDMO

Societal CDMO (NASDAQ: SCTL) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.

In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

Societal CDMO: Bringing Science to Society. For more information about Societal CDMO’s customer solutions, visit societalcdmo.com.

About Xequel Bio, Inc.

Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. Xequel’s lead clinical programs include Granexin^® gel in dermatology and iNexin™ ophthalmic solution in ophthalmology. For more information, please visit www.xequel.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, relate to the Company’s expectations regarding the completion of the proposed public offering, the Company’s use of proceeds from the proposed offering, and other statements. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks and uncertainties associated with demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the company’s manufacturing services; the average profitability, or mix, of the products the company manufactures; the company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
[email protected]

Tim Brons (Media)
Vida Strategic Partners
415-675-7402
[email protected]

Ryan D. Lake (CFO)
Societal CDMO
770-531-8365
[email protected]

Trevena’s partner, Jiangsu Nhwa, receives approval from Chinese National Medical Products Administration (NMPA)

Approval achieves $3 million milestone to Trevena from Jiangsu Nhwa

Additional $15 million to Trevena expected on first commercial sale in China, based on ex-US Royalty-Based Financing with R-Bridge Healthcare Fund, an affiliate of CBC Group

CHESTERBROOK, Pa., May 08, 2023 (GLOBE NEWSWIRE) — Trevena, Inc.(Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that its partner in China, Jiangsu Nhwa, received formal approval from the National Medical Products Administration for OLINVYK. It has been approved for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

“We are very pleased to see our partners, Jiangsu Nhwa, achieve this important milestone which will allow Chinese patients to benefit from OLINVYK,” said Carrie Bourdow, President and CEO of Trevena. “We have worked closely with our partners during their submission process, and look to our continued collaboration as they move forward with launch and full commercialization of OLINVYK in China.”

The Chinese regulatory agency (NMPA) accepted the NDA in January 2022. The approval is based on results of two bridging trials conducted in China and also leveraged US clinical data. Results from the bridging studies demonstrated that the safety, tolerability and pharmacokinetic profile of OLINVYK in Chinese patients is consistent with what has been seen in other OLINVYK clinical trials. Jiangsu Nhwa has an exclusive license agreement for the development and commercialization of OLINVYK in China.

Trevena is due to receive a $3 million milestone payment from Jiangsu Nhwa with the approval. The Company is also eligible to receive $15 million upon first commercial sale of OLINVYK in China, in connection with its non-dilutive royalty-based financing with an affiliate of R-Bridge Healthcare Fund (the R-Bridge Financing). As part of the R-Bridge Financing, Trevena previously received a $15 million upfront payment and may receive an additional $10 million upon achievement of either a commercial or financing milestone.

About OLINVYK
®
(oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS

ADDICTION, ABUSE, AND MISUSE – OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions.

LIFE-THREATENING RESPIRATORY DEPRESSION – Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase.

NEONATAL OPIOID WITHDRAWAL SYNDROME – Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS – Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

INDICATIONS AND USAGE

OLINVYK is an opioid agonist indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

• Have not been tolerated, or are not expected to be tolerated
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Known hypersensitivity to oliceridine (e.g., anaphylaxis)

WARNINGS AND PRECAUTIONS

• OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
• Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper.
• Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
• OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg.
• Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses.
• Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid.
• OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure.
• Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used with caution in patients who may be susceptible to the intracranial effects of CO₂ retention, such as those with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the resultant CO₂ retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy.
• As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
• OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable patients. Monitor patients with a history of seizure disorders for worsened seizure control.
• Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal symptoms.
• OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
• Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Health care providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive sedation, respiratory depression, or other adverse effects of opioid medications.

ADVERSE REACTIONS

Adverse reactions are described in greater detail in the Prescribing Information.
The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
MEDICAL INFORMATION
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the Trevena Medical Information Contact Center at 1-844-465-4686 or email [email protected].
You are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of discussions with FDA; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK^® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.

For more information, please visit www.Trevena.com 

About Jiangsu Nhwa:

Jiangsu Nhwa Pharmaceutical Co., Ltd. (SZ002262), founded in 1978, is a leading CNS company in China. Over the past 40 years, Nhwa is exclusively dedicated to developing innovative and differentiated pipeline in the areas of anesthesia, analgesia, psychiatry and neurology via in-house R&D and global partnership.

As a fully integrated pharmaceutical company with more than 4000 employees, Nhwa has comprehensive capabilities in research, clinical development, manufacturing and commercialization of CNS drugs. In recent years, Nhwa has further strengthened its leadership in CNS field in China by providing the services of precision diagnosis of CNS disorders (Shanghai N-yuen Biotechnology Company), and investing the largest Chinese CNS internet health platform (Happy Mood).

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
(617) 430-7576

Company Contact:

Bob Yoder
SVP and Chief Business Officer
Trevena, Inc.
(610) 354-8840

Auvelity

^®

1Q 2023 net product sales of $15.7 million

Total 1Q 2023 net product sales of $28.6 million

Total 1Q 2023 revenue of $94.6 million, including Sunosi

^®

ex-U.S. license agreement upfront payment

Company to host conference call today at 8:00 AM Eastern

NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2023.

“The first quarter of 2023 was another important milestone for Axsome as it marked the first full quarter of launch for Auvelity. Based on the performance in the quarter, we are pleased that our marketed products are making a difference in the lives of a growing number of patients with major depressive disorder for Auvelity, and with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea for Sunosi,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “At the same time, our broad late-stage pipeline continues to advance with important near and intermediate term clinical and regulatory milestones including pivotal trial initiations, read-outs, and NDA filings. Our strong commercial, research, and financial profile positions us to continue to develop and deliver differentiated treatments for the millions of patients living with difficult-to-treat CNS disorders.”

First Quarter 2023 Financial Highlights

• Total revenue for the first quarter of 2023 was $94.6 million, consisting of net product sales of $28.6 million, license revenue of $65.7 million, and royalty revenue of $0.3 million. The license revenue represents the upfront payment from Pharmanovia for Sunosi commercialization rights in Europe and certain countries in the Middle East and North Africa region, and the royalty revenue associated with sales of Sunosi in the out-licensed territories. There was no revenue for the 2022 comparable period reflecting the timing of the Auvelity launch and the Sunosi acquisition.
• Auvelity net product sales were $15.7 million for the first quarter of 2023.
• Sunosi net product sales were $12.9 million for the first quarter of 2023, including $1.7 million in international net sales booked by Axsome. An additional $0.3 million in royalty revenue associated with Sunosi sales in the out-licensed territories was recognized. Reported Sunosi net sales in the first quarter were negatively impacted by an estimated one-time $3.3 million reduction in inventory due to a change in distribution from a title to a traditional 3PL model in the U.S, as anticipated.
• Total cost of revenue was $7.6 million for the first quarter of 2023, consisting of cost of goods sold of $2.6 million and a one-time $5 million license revenue sharing expense related to the Pharmanovia agreement.
• Research and development (R&D) expenses were $17.8 million for the first quarter of 2023, compared to $12.6 million for the comparable period in 2022. The increase was primarily related to higher personnel costs associated with ongoing clinical trials, post-marketing commitments for Auvelity and Sunosi and non-cash stock-based compensation expense.
• Selling, general, and administrative (SG&A) expenses were $74.2 million for the first quarter of 2023, compared to $25.7 million for the comparable period in 2022. The increase was primarily related to commercial activities for Auvelity and Sunosi and higher non-cash stock-based compensation expense.
• Net loss for the first quarter of 2023 was $11.2 million or $(0.26) per share, compared to a net loss of $39.6 million, or $(1.03) per share, for the comparable period in 2022. The net loss in the first quarter of 2023 reflects the upfront license revenue received from Pharmanovia and includes $12.9 million of non-cash stock-based compensation expense compared to $7.6 million for the comparable period in 2022.
• Cash and cash equivalents totaled $246.5 million at March 31, 2023, compared to $200.8 million at December 31, 2022.
• In January 2023, Axsome amended its term loan facility agreement with Hercules Capital increasing the size of the facility to $350 million, reducing the interest rate, and extending the maturity and interest-only period, while accessing a new $55 million tranche. There is currently $200 million available on the term loan facility.
• Shares of common stock outstanding were 43,548,466 at March 31, 2023.

Financial Guidance

• Axsome believes that its current cash, along with the remaining committed capital from the $350 million term loan facility, is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.

Commercial Highlights

Auvelity

• The first quarter of 2023 was the first full quarter of sales for Auvelity, which was launched in October 2022. Approximately 31,000 prescriptions were reported for Auvelity in the first quarter of 2023, representing a 298% sequential increase versus the fourth quarter of 2022.
• Payer coverage for Auvelity across all channels is currently approximately 65% of all covered lives. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are approximately 40% and approximately 100%, respectively.
• Axsome’s comprehensive patient and provider support services for Auvelity continue to perform as planned. The Auvelity on My Side program is designed to help clinicians and patients easily access Auvelity and the program includes: the Auvelity Savings Card to reduce out-of-pocket expenses for qualifying patients, telehealth services, HCP samples, and prior authorization assistance.

Sunosi

• First quarter 2023 U.S. Sunosi total prescriptions increased by 13% versus the first quarter of 2022, and by 4% versus the fourth quarter of 2022.
• Sunosi maintains broad payer coverage in the commercial channel with 96% of lives covered. Currently 83% of total lives across all channels are covered.
• Axsome’s patient and provider support services for Sunosi, including the Sunosi Savings Card, continue to perform as planned.
• In February 2023, Axsome licensed the marketing rights for Sunosi in Europe and certain countries in the Middle East and North Africa to Pharmanovia. In consideration, Axsome received an upfront payment of $66M, with potential milestones up to $101M. Axsome will receive a royalty percentage in the mid-twenties on net sales in the licensed territory. Pharmanovia will assume responsibility for all local clinical and regulatory activities and requirements including studies in pediatric patients with narcolepsy.

Development Pipeline

Axsome is advancing a portfolio of differentiated, patent-protected, CNS product candidates with five in active clinical development. Recent and anticipated progress for key pipeline programs is summarized below.

AXS-05

AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for AD agitation.

• Alzheimer’s Disease Agitation: The Company is conducting the ADVANCE-2 study, a Phase 3, placebo-controlled, parallel group trial to assess the efficacy and safety of AXS-05 for the treatment of AD agitation. Patients completing ADVANCE-2 may enter a long-term open label safety extension trial. Based on current enrollment trends, the Company continues to anticipate completion of ADVANCE-2 in the first half of 2024.
• Smoking Cessation: Axsome plans to proceed to a pivotal Phase 2/3 trial in this indication. The Company anticipates initiation of this study in the fourth quarter of 2023.

AXS-07

AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine.

• Migraine: Manufacturing activities related to the planned resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine are ongoing. The Company continues to anticipate resubmission of the NDA in the second half of 2023. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review.

AXS-12

AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy.

• Narcolepsy: Axsome is conducting the SYMPHONY study, a Phase 3 randomized, multicenter, double-blind, placebo-controlled, parallel-group trial of AXS-12 in the treatment of narcolepsy. Enrollment in the trial is progressing and topline results continue to be anticipated in the second quarter of 2023.

AXS-14

AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.

• Fibromyalgia: Manufacturing and other activities related to the planned submission of an NDA for AXS-14 for the management of fibromyalgia are ongoing. The Company expects to submit the NDA in 2023. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the management of fibromyalgia.

Solriamfetol

Solriamfetol is Axsome’s dual-acting dopamine and norepinephrine reuptake inhibitor in development for the treatment of attention deficit hyperactivity disorder (ADHD).

• ADHD: The Company is on track to initiate a Phase 3 multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of solriamfetol in adults with ADHD in the second quarter of 2023.

Anticipated Milestones

• Regulatory and Commercial:
  • AXS-07 for migraine, NDA resubmission (2H 2023)
  • AXS-14 for fibromyalgia, NDA submission (4Q 2023)
• Clinical Trial Readouts:
  • Phase 3 SYMPHONY trial of AXS-12 in narcolepsy, topline data (2Q 2023)
  • Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (1H 2024)
• Clinical Trial Initiations:
  • Phase 3 trial of solriamfetol for ADHD in adults (2Q 2023)
  • Pivotal Phase 2/3 trial of AXS-05 for smoking cessation (4Q 2023)

Conference Call Information

Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss first quarter 2023 financial results as well as to provide a corporate update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi^® and Auvelity^® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

Axsome Therapeutics, Inc.

Selected Consolidated Financial Data

Axsome Therapeutics, Inc.

Consolidated Balance Sheets

(In thousands, except for share and par value amounts)

	March 31,				December 31,
	2023				2022
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	246,515			$	200,842
Accounts receivables, net		44,793				37,699
Inventories, net		7,940				4,320
Prepaid and other current assets		5,201				2,781
Total current assets		304,449				245,642
Equipment, net		703				722
Right-of-use asset – operating lease		106				420
Goodwill		10,310				10,310
Intangible asset, net		58,089				59,661
Non-current inventory and other assets		15,522				14,721
Total assets	$	389,179			$	331,476
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	35,770			$	38,605
Accrued expenses and other current liabilities		58,774				51,631
Operating lease liability, current portion		108				425
Contingent consideration, current		6,000				5,900
Total current liabilities		100,652				96,561
Contingent consideration, non-current		29,100				31,100
Loan payable, long-term		147,615				94,259
Total liabilities		277,367				221,920
Stockholders’ equity:
Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding at March 31, 2023 and December 31, 2022, respectively)		—				—
Common stock, $0.0001 par value per share (150,000,000 shares authorized, 43,548,466 and 43,498,617 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively)		4				4
Additional paid-in capital		719,359				705,885
Accumulated deficit		(607,551	)			(596,333	)
Total stockholders’ equity		111,812				109,556
Total liabilities and stockholders’ equity	$	389,179			$	331,476

Axsome Therapeutics, Inc.

Consolidated Statements of Operations (Unaudited)

(In thousands, except share and per share amounts)

	Three Months Ended
	March 31,
	2023				2022
Revenues:
Product sales, net	$	28,569			$	—
License revenue		65,735				—
Royalty revenue		272				—
Total Revenues		94,576				—
Operating expenses:
Cost of revenue (excluding amortization and depreciation)		7,556				—
Research and development		17,793				12,585
Selling, general and administrative		74,191				25,704
Gain in fair value of contingent consideration		(162	)			—
Intangible asset amortization		1,572				—
Total operating expenses		100,950				38,289
Loss from operations		(6,374	)			(38,289	)
Interest expense, net		(2,264	)			(1,343	)
Income before provision for income taxes		(8,638	)			(39,632	)
Provision for income taxes		(2,580	)			—
Net loss	$	(11,218	)		$	(39,632	)
Net loss per common share, basic and diluted	$	(0.26	)		$	(1.03	)
Weighted average common shares outstanding, basic and diluted		43,523,631				38,323,167

Axsome Contacts:

Investors:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
One World Trade Center, 22^nd Floor
New York, NY 10007
Tel: 212-332-3243
Email: [email protected]
www.axsome.com

Media:

Darren Opland
Director, Corporate Communications
Axsome Therapeutics, Inc.
One World Trade Center, 22^nd Floor
New York, NY 10007
Tel: 929-837-1065
Email: [email protected]
www.axsome.com

SAN FRANCISCO, May 08, 2023 (GLOBE NEWSWIRE) — Augmedix Inc. (Nasdaq: AUGX), a healthcare technology company that delivers ambient medical documentation and data solutions to healthcare systems, physician practices, hospitals, and telemedicine practitioners, today announced it will report financial results for the first quarter ended March 31, 2023, on Friday, May 12, 2023, before the market opens. Company management will host a conference call that day at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time.

Live audio of the conference call will be available on the “Events” section of the Company’s website at: https://ir.augmedix.com/news-events. Alternatively, interested parties can dial 877-407-3982 (toll-free) or 201-493-6780 (international) to listen. The webcast will be archived and available for replay after the event.

About Augmedix

Augmedix (Nasdaq: AUGX) delivers industry-leading, ambient medical documentation and data solutions to healthcare systems, physician practices, hospitals, and telemedicine practitioners. Augmedix is on a mission to help clinicians and patients form a human connection at the point of care with seamless technology. Augmedix’s proprietary Notebuilder Platform extracts relevant data from natural clinician-patient conversations and converts that data into medical notes in real time, which are seamlessly transferred to the EHR. The Company’s platform uses Automatic Speech Recognition, Natural Language Processing including Large Language Models, and medical documentation specialists to generate accurate and timely medical notes. Leveraging this platform, Augmedix’s products relieve clinicians of administrative burden, in turn, reducing burnout and increasing both clinician and patient satisfaction. Augmedix is also leading the revolution in leveraging point-of-care data by making connections between millions of clinician-patient interactions and analyzing them to deliver actionable insights that elevate patient care. Augmedix is headquartered in San Francisco, CA, with offices around the world. To learn more, visit www.augmedix.com.

Contact Information

Investors:
Matt Chesler, CFA
FNK IR
(646) 809-2183
[email protected]
[email protected]

Media:
Kaila Grafeman
Augmedix
[email protected]

SAN JOSE, Calif., May 08, 2023 (GLOBE NEWSWIRE) — Zscaler, Inc. (NASDAQ: ZS), the leader in cloud security, today announced certain preliminary unaudited financial results for the third quarter of fiscal year 2023, ended April 30, 2023. All figures in this release are approximate due to the preliminary nature of the announcement.

“I am pleased to announce that our preliminary third quarter results exceeded the high end of our guidance range. We had a strong finish to the quarter as the high ROI of adopting the Zscaler Zero Trust Exchange^TM platform continues to resonate with customers and prospects in this challenging macro environment,” said Jay Chaudhry, Chairman and CEO of Zscaler. “Our customer engagements are strong, and our platform continues to expand with innovations that solve our customers’ real time IT challenges. We look forward to sharing more details on our upcoming earnings conference call.”

Based on our preliminary review, we expect to report the following results for the third quarter ended April 30, 2023:

	Preliminary Results	Prior Guidance
Revenue	$415 million to $419 million	$396 million to $398 million
GAAP loss from operations	$59 million to $55 million	Not provided
Non-GAAP income from operations	$60 million to $64 million	$55 million to $56 million

Based on our preliminary review, we also expect to report calculated billings of approximately $478 million to $482 million, an increase of approximately 38% to 39% year-over-year.

We expect full year fiscal 2023 results to exceed prior guidance:

	Updated Guidance	Prior Guidance
Revenue	$1,587 million to $1,591 million	$1,558 million to $1,563 million
Calculated billings	$1,970 million to $1,974 million	$1,935 million to $1,945 million
Non-GAAP income from operations (*)	$220 million to $224 million	$213 million to $215 million

(*) Guidance for non-GAAP income from operations excludes stock-based compensation expense and related employer payroll taxes, amortization expense of acquired intangible assets and restructuring and other charges. We have not reconciled our expectations for non-GAAP income from operations to its most directly comparable GAAP measures because certain items are out of our control or cannot be reasonably predicted. For those reasons, we are also unable to address the probable significance of the unavailable information, the variability of which may have a significant impact on future results. Accordingly, a reconciliation for the guidance for non-GAAP income from operations is not available without unreasonable effort.

ZSCALER, INC.
Reconciliation of Preliminary GAAP to Preliminary Non-GAAP Financial Measures
(in millions)
(unaudited)
	Three Months Ended
	April 30, 2023
	Range of Preliminary Results
Revenue	$	415			$	419
Non-GAAP Income from Operations:
GAAP loss from operations	$	(59	)		$	(55	)
Adjustments (1)		119				119
Non-GAAP income from operations	$	60			$	64
Calculated Billings:
Revenue	$	415			$	419
Add: Total deferred revenue, end of period		1,175				1,175
Less: Total deferred revenue, beginning of period		(1,112	)			(1,112	)
Calculated billings	$	478			$	482

(1) Reflects the mid-point of the range of estimate of adjustments for stock-based compensation expense and related employer payroll taxes of approximately $111 million, amortization expense of acquired intangible assets of approximately $3 million, and restructuring and other charges of approximately $5 million.

Our preliminary results and guidance for non-GAAP income from operations excludes stock-based compensation expense and related employer payroll taxes, amortization expense of acquired intangible assets and restructuring and other charges.

In the third quarter of fiscal 2023, we updated our definition of non-GAAP income from operations to include restructuring and other charges.

For further information regarding why we believe that these non-GAAP measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the “Explanation of Non-GAAP Financial Measures” section of this press release.

Preliminary Results

We are currently in the process of finalizing our full financial results for the quarter ended April 30, 2023 and applying our normal closing procedures and, therefore, the estimated revenues, non-GAAP operating income, and calculated billings presented above reflect various assumptions and estimates based only upon information available to us as of the date hereof. As a result, while we consider the preliminary amounts to be a reasonable estimate, it remains subject to change and actual results may differ due to developments or other information that may arise between now and the time the full financial results for the third quarter ended April 30, 2023 are finalized.

Earnings Conference Call and Webcast Information

Zscaler will release third quarter fiscal year 2023 earnings after the market close on Thursday, June 1, 2023. We will host an investor conference call that day at 1:30 p.m. Pacific time (4:30 p.m. Eastern time) to discuss the results.

	Date:	Thursday, June 1, 2023
	Time:	1:30 p.m. PT
	Webcast:	https://ir.zscaler.com
	Dial-in:	To join by phone, register at the following link: Click Here. After registering, you will be provided with a dial-in number and a personal PIN that you will need to join the call.

Please dial in at least 10 minutes prior to the 1:30 p.m. PT start time. A live webcast of the conference call will be accessible from the Zscaler website at ir.zscaler.com. Listeners may log on to the call under the “Events & Presentations” section and select “Q3 2023 Zscaler Earnings Conference Call” to participate.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including, but not limited to, statements regarding our future financial and operating performance, including our updated financial outlook for the third quarter of fiscal 2023 and full year fiscal 2023. There are a significant number of factors that could cause actual results to differ materially from statements made in this press release, including but not limited to: macroeconomic influences and instability, including the ongoing effects of inflation, geopolitical events and the COVID-19 pandemic on our business, operations and financial results and the economy in general; the uncertainty about the raising of the US federal government debt limit and the impact of a government default or shut-down; our limited operating history; our ability to identify and effectively implement the necessary changes to address execution challenges; risks associated with managing our rapid growth, including fluctuations from period to period; our limited experience with new product and subscription and support introductions and the risks associated with new products and subscription and support offerings, including the discovery of software bugs; our ability to attract and retain new customers; the failure to timely develop and achieve market acceptance of new products and subscriptions as well as existing products and subscription and support; rapidly evolving technological developments in the market for network security products and subscription and support offerings and our ability to remain competitive; length of sales cycles; and general market, political, economic and business conditions.

Additional risks and uncertainties that could affect our financial results are included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” set forth from time to time in our filings and reports with the Securities and Exchange Commission (SEC), including our Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2023 filed on March 8, 2023 and our Annual Report on Form 10-K for the fiscal year ended July 31, 2022 filed on September 15, 2022, as well as future filings and reports by us, copies of which are available on our website at ir.zscaler.com and on the SEC’s website at www.sec.gov. You should not rely on these forward-looking statements, as actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of such risks and uncertainties. Additional information will also be set forth in other filings that we make with the SEC from time to time. All forward-looking statements in this press release are based on information available to us as of the date hereof, and we do not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.

Use of Non-GAAP Financial Information

We believe that the presentation of non-GAAP financial information provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. For further information regarding why we believe that these non-GAAP measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the “Explanation of Non-GAAP Financial Measures” section of this press release.

About Zscaler

Zscaler (NASDAQ: ZS) accelerates digital transformation so customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange protects thousands of customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Distributed across more than 150 data centers globally, the SSE-based Zero Trust Exchange is the world’s largest in-line cloud security platform.

Zscaler™ and the other trademarks listed at


https://www.zscaler.com/legal/trademarks


are either (i) registered trademarks or service marks or (ii) trademarks or service marks of Zscaler, Inc. in the United States and/or other countries. Any other trademarks are the properties of their respective owners.

Media Relations Contact

Natalia Wodecki
[email protected]

Investor Relations Contact

Bill Choi, CFA
[email protected]

ZSCALER, INC.

Explanation of Non-GAAP Financial Measures

     In addition to our results determined in accordance with generally accepted accounting principles in the United States of America (GAAP), we believe the following non-GAAP measures are useful in evaluating our operating performance. We use the following non-GAAP financial information to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. In addition, other companies, including companies in our industry, may calculate similarly-titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. A reconciliation of our preliminary non-GAAP financial measures to their most directly comparable financial measures stated in accordance with GAAP has been included in this press release. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures and key metrics as analytical tools. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate our business.

Expenses Excluded from Non-GAAP Measures

     Stock-based compensation expense is excluded primarily because it is a non-cash expense that management believes is not reflective of our ongoing operational performance. Employer payroll taxes related to stock-based compensation, which is a cash expense, are excluded because these are tied to the timing and size of the exercise or vesting of the underlying equity awards and the price of our common stock at the time of vesting or exercise, which may vary from period to period independent of the operating performance of our business. Amortization expense of intangible assets acquired in business acquisitions and related income tax effects, if applicable, are excluded because these are considered by management to be outside of our core business operating performance. Restructuring and other charges related to severance and termination benefits in connection with a restructuring plan to streamline operations and to align people, roles and projects to our strategic priorities are excluded because these fluctuate in amounts and frequency and are not reflective of our core business operating performance.

Non-GAAP Financial Measures

     Non-GAAP Income from Operations
. We define non-GAAP income from operations as GAAP loss from operations excluding stock-based compensation expense and related employer payroll taxes, amortization expense of acquired intangible assets and restructuring and other charges. In the third quarter of fiscal 2023, we updated the definition of non-GAAP income from operations to include restructuring and other charges as defined in the preceding paragraph.

     Calculated Billings
. We define calculated billings as revenue plus the change in deferred revenue in a period. Calculated billings in any particular period aims to reflect amounts invoiced for subscriptions to access our cloud platform, together with related support services for our new and existing customers. We typically invoice our customers annually in advance, and to a lesser extent quarterly in advance, monthly in advance or multi-year in advance.

• Customer Activity Remains Robust with Expanding Pipelines in 5G Mobile, Wi-Fi CPE, 5G Infrastructure, Automotive, Timing Control, Semiconductor Back-End-Services, and Other Markets
• Completed Acquisition of Grinding & Dicing Services, Inc. (“GDSI”), Adding Back-End Services Business to Portfolio During the March Quarter
• Akoustis Began Shipping into the 5G Mobile Market in Q3 FY23, Ramping the Largest Market by Potential Revenue and Unit Volume
• Submitted Application for the Department of Defense Portion of the CHIPs Act
• Company to Host Investor Update Call Today at 8:00 am ET

Charlotte, N.C., May 08, 2023 (GLOBE NEWSWIRE) — Akoustis Technologies, Inc. (NASDAQ: AKTS) (“Akoustis” or the “Company”), an integrated device manufacturer (IDM) of patented bulk acoustic wave (BAW) high-band RF filters for mobile and other wireless applications, announced today a 160% year-over-year increase in quarterly revenue to a record $7.4 million for the fiscal quarter ended March 31, 2023.

Based on hundreds of active customers, robust activity in the sales and design win pipelines, and the semiconductor services business, as well as new product introductions in 5G mobile, 5G network infrastructure, Wi-Fi 6E and Wi-Fi 7, and the defense market, the Company expects to report another quarter of record revenue in the current June quarter with a sequential increase of 10%-20%, despite the ongoing macroeconomic challenges facing the consumer electronics industry.

Akoustis will host an investor call to provide a business update and outlook, followed by a Q & A session, this morning at 8:00 am ET. The call-in numbers are 877-407-3982 (domestic) and +01 201-493-6780 (international). The conference call will be webcast live on the Company’s website and will be available for playback at the following URL: https://ir.akoustis.com/ir-calendar.

Jeff Shealy, founder and CEO of Akoustis, stated, “Despite the persistent macro challenges, Akoustis was able to deliver its sixth consecutive quarter of record revenue. Our sales growth was driven by multiple factors including 5G mobile shipments to our first tier-1 customer, continued execution in our Wi-Fi business punctuated by the notable entry into the US cable carrier market, our first Wi-Fi 7 design win, and the positive integration of GDSI following its acquisition in January. Additionally, we made inroads in our other areas including defense, timing control, automotive and other markets.”

Akoustis continues to experience strong demand and a growing sales funnel for its Wi-Fi, 5G mobile, and 5G infrastructure products, as well as its new XBAW^®/SAW resonator and oscillator products, and semiconductor back-end services. During the June quarter, the Company plans to ship samples of its new 5.6 GHz/6.6 GHz Wi-Fi 6E/7 XBAW^® filter products to multiple customers. Akoustis continues to add new Wi-Fi design wins, many of which are expected to ramp into production in calendar 2023.

Recent Business Highlights

• Started shipping 5G mobile XBAW^® filters, incorporating our production released WLP technology, to our tier-1 RF component company customer to support production ramp
• Received order for second filter from first tier-1 5G mobile customer for expected CY24 product ramp
• Delivered second of two 5G mobile filters to second tier-1 customer for down-selection
• Delivered second iteration of initial XBAW^® filter to third tier-1 mobile customer
• Started production ramp with tier-1 US-based cable carrier company supporting Wi-Fi 6E
• Secured first Wi-Fi 7 design win from enterprise-class customer
• Received order for new Wi-Fi 6E/Wi-Fi 7 XBAW^® filters from new second-tier customer
• Introduced new automotive C-V2X filter and began sampling to multiple customers
• Qualified the first of two XBAW^® resonators for our first timing control customer
• Completed the acquisition of GDSI, a diverse, premium semiconductor back-end services business on January 1, 2023
• Continued DARPA direct-to-phase II (DP2) contract to advance design and manufacturing of XBAW^® technology for filters and other sensors
• The Company’s XBAW^® patent portfolio grew to 89 issued and licensed patents, plus 124 patents pending as of April 28, 2023

Akoustis is actively delivering volume production of its Wi-Fi 6 and 6E tandem filter solutions, shipping multiple 5G small cell XBAW^® filter solutions, is delivering initial designs of its new 5G mobile filter solutions to multiple customers, and has entered the market with its new Wi-Fi 7 coexistence XBAW^® filter solutions.

Given its healthy sales funnel activity, as well as ongoing interaction with customers regarding expected ramps in 5G mobile, Wi-Fi 6E and Wi-Fi 7 in calendar 2023, the Company has essentially completed its production capacity expansion increase at its New York fab to approximately 0.5 billion filters per year.

Third Fiscal Quarter Financial Performance

Akoustis Technologies, Inc.

Condensed Consolidated Balance Sheets
(In thousands, except share data)
(Unaudited)

							March 31,						June 30,
							2023						2022
Assets
Assets:
Cash and cash equivalents							$		52,749				$	80,485
Accounts receivable									4,247					3,793
Inventory									7,558					4,094
Other current assets									3,665					3,359
Total current assets									68,219					91,731
Property and equipment, net									57,313					51,157
Goodwill									14,530					8,051
Intangibles, net									15,889					8,994
Operating lease right-of-use asset, net									1,483					1,126
Other assets									71					279
Total Assets							$		157,505				$	161,338
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses							$		11,270				$	11,204
Contingent consideration									8					855
Deferred revenue									114					286
Operating lease liability									415					313
Total current liabilities									11,807					12,658
Long-term Liabilities:
Convertible notes payable, net									43,696					43,731
Promissory notes payable									333					—
Contingent consideration									—					591
Operating lease liability									1,092					811
Other long-term liabilities									117					117
Total long-term liabilities									45,239					45,250
Total Liabilities									57,046					57,908
Stockholders’ Equity
Preferred stock, par value $0.001; 5,000,000 shares authorized; none issued and outstanding									—					—
Common stock, $0.001 par value; 125,000,000 shares authorized; 71,625,149, and 57,079,347 shares issued and outstanding on March 31, 2023, and June 30, 2022, respectively									72					57
Additional paid in capital									352,977					310,171
Accumulated deficit									(252,590	)				(206,798	)
Total Stockholders’ Equity									100,459					103,430
Total Liabilities and Stockholders’ Equity							$		157,505				$	161,338

Akoustis Technologies, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

		For the Three Months Ended March 31, 2023				For the Three Months Ended March 31, 2022				For the Nine Months Ended March 31, 2023				For the Nine Months Ended March 31, 2022
Revenue		$	7,356			$	4,607			$	18,788			$	10,146
Cost of revenue			8,472				5,370				20,200				12,821
Gross profit (loss)			(1,116	)			(763	)			(1,412	)			(2,675	)
Operating expenses
Research and development			7,349				8,314				25,079				25,481
General and administrative expenses			8,817				5,721				21,650				14,742
Total operating expenses			16,166				14,035				46,729				40,223
Loss from operations			(17,282	)			(14,798	)			(48,141	)			(42,898	)
Other (expense) income
Interest (expense) income			(510	)			25				(1,955	)			88
Other (expense) income			(1	)			—				(10	)			—
Change in fair value of contingent consideration			268				(180	)			1,438				(180	)
Change in fair value of derivative liabilities			(383	)			—				456				—
Total other (expense) income			(626	)			(155	)			(71	)			(92	)
Net loss before income taxes		$	(17,908	)		$	(14,953	)		$	(48,212	)		$	(42,990	)
Income Tax (expense) benefit			2,364				(128	)			2,420				(70	)
Net Loss		$	(15,545	)		$	(14,825	)		$	(45,792	)		$	(42,920	)
Net loss (income) attributable to noncontrolling interest			—				139				—				121
Net loss attributable to common stockholders		$	(15,545	)		$	(14,686	)		$	(45,792	)		$	(42,799	)
Net loss per common share – basic and diluted		$	(0.23	)		$	(0.27	)		$	(0.75	)		$	(0.81	)
Weighted average common shares outstanding – basic and diluted			68,195,181				55,217,220				60,925,124				53,177,679

The following non-GAAP measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. These non-GAAP measures exclude significant expenses that are required by GAAP to be recorded in the Company’s financial statements and are subject to inherent limitations. Please see reconciliations to comparable GAAP measures below and descriptions of these non-GAAP measures under “non-GAAP measures.”

Non-GAAP operating loss and non-GAAP net loss for the quarters ended March 31, 2023, and 2022 were as follows:

	Three Months Ended
	March 31, 2023	March 31, 2022
(in thousands)
GAAP operating loss	$        (17,282)	$       (14,798)
Amortization of acquisition-related intangible assets	659	537
Recognition of acquisition-related promissory note	333	–
Gain on sale of fixed assets	(121)	(9)
Common stock issued for services	3,211	2,506
Non-GAAP operating loss	$       (13,200)	$       (11,764)
Weighted average common shares outstanding – basic and diluted	68,195,181	55,217,220
Non-GAAP operating loss per common share – basic and diluted	$            (0.19)	$           (0.21)
	Three Months Ended
	March 31, 2023	March 31, 2022
(in thousands)
GAAP net loss	$   (15,545)	$   (14,825)
Change in fair value of contingent consideration	(268)	180
Change in fair value of derivative liabilities	383	–
Amortization of acquisition-related intangible assets	659	537
Recognition of acquisition-related promissory note	333	–
Debt discount amortization	131	–
Gain on sale of fixed assets	(121)	(9)
Tax adjustments related to acquisitions	(2,420)	–
Common stock issued for services	3,211	2,506
Non-GAAP net loss	$       (13,637)	$       (11,611)
Weighted average common shares outstanding – basic and diluted	68,195,181	55,217,220
Non-GAAP net loss per common share – basic and diluted	$            (0.20)	$           (0.21)
	Nine Months Ended
	March 31, 2023	March 31, 2022
(in thousands)
GAAP operating loss	$       (48,140)	$       (42,897)
Amortization of acquisition-related intangible assets	1,354	537
Recognition of acquisition-related promissory note	333	–
Gain on sale of fixed assets	(105)	(204)
Common stock issued for services	7,455	7,754
Non-GAAP operating loss	$       (39,103)	$       (34,810)
Weighted average common shares outstanding – basic and diluted	60,925,124	53,177,679
Non-GAAP operating loss per common share – basic and diluted	$            (0.64)	$           (0.65)
	Nine Months Ended
	March 31, 2023	March 31, 2022
(in thousands)
GAAP net loss	$   (45,792)	$   (42,920)
Change in fair value of contingent consideration	(1,438)	180
Change in fair value of derivative liabilities	(456)	–
Amortization of acquisition-related intangible assets	1,354	537
Recognition of acquisition-related promissory note	333	–
Tax adjustments related to acquisitions	(2,420)	–
Gain on sale of fixed assets	(105)	(204)
Debt discount amortization	421	–
Common stock issued for services	7,455	7,754
Non-GAAP net loss	$       (40,648)	$       (34,653)
Weighted average common shares outstanding – basic and diluted	60,925,124	53,177,679
Non-GAAP net loss per common share – basic and diluted	$            (0.67)	$           (0.65)

Non-GAAP Measures

We regularly review a number of metrics, including non-GAAP operating loss and non-GAAP net loss, which are not financial measures calculated in accordance with generally accepted accounting principles in the United States (“GAAP”). Non-GAAP operating loss represents operating loss before common stock issued for services, amortization of acquisition-related intangible assets, recognition of acquisition-related promissory note, and gain or loss on the sale of fixed assets. Non-GAAP net loss represents net loss before change in fair value of contingent consideration, change in fair value of derivative liabilities, debt discount amortization, gain on extinguishment of debt, gain or loss on disposal of fixed assets, recognition of acquisition-related promissory note, amortization of acquisition-related intangible assets, tax adjustments related to acquisitions and common stock issued for services. The Company believes these non-GAAP measures provide useful information to management, investors, and financial analysts regarding certain financial and business trends relating to the Company’s financial condition and results of operations. We use these non-GAAP measures to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions.

About Akoustis Technologies, Inc.

Akoustis^® (http://www.akoustis.com/) is a high-tech BAW RF filter solutions company that is pioneering next-generation materials science and MEMS wafer manufacturing to address the market requirements for improved RF filters – targeting higher bandwidth, higher operating frequencies and higher output power compared to legacy polycrystalline BAW technology. The Company utilizes its proprietary and patented XBAW^® manufacturing process to produce bulk acoustic wave RF filters for mobile and other wireless markets, which facilitate signal acquisition and accelerate band performance between the antenna and digital back end. Superior performance is driven by the significant advances of poly-crystal, single-crystal and other high purity piezoelectric materials and the resonator-filter process technology which enables optimal trade-offs between critical power, frequency and bandwidth performance specifications. 

Akoustis plans to service the fast growing, multi-billion-dollar RF filter market, using its integrated device manufacturer (IDM) business model. The Company owns and operates a 120,000 sq. ft. ISO-9001:2015 registered commercial wafer-manufacturing facility located in Canandaigua, NY, which includes a class 100 / class 1000 cleanroom facility – tooled for 150-mm diameter wafers – for the design, development, fabrication and packaging of RF filters, MEMS and other semiconductor devices. Akoustis Technologies, Inc. is headquartered in the Piedmont technology corridor near Charlotte, North Carolina.

Forward-Looking Statements

This document includes “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, each as amended, that are intended to be covered by the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements about our estimates, expectations, beliefs, intentions, plans or strategies for the future (including our possible future results of operations, profitability, business strategies, competitive position, potential growth opportunities, potential market opportunities and the effects of competition), the anticipated benefits of the acquisition of Grinding and Dicing Services, Inc., future cash flow and forecasts of breakeven point and expectations regarding funding under the CHIPS and Science Act, and the assumptions underlying such statements. Forward-looking statements include all statements that are not historical facts and typically are identified by use of terms such as “may,” “might,” “would,” “will,” “should,” “could,” “project,” “expect,” “plan,” “strategy,” “anticipate,” “attempt,” “develop,” “help,” “believe,” “think,” “estimate,” “predict,” “intend,” “forecast,” “seek,” “potential,” “possible,” “continue,” “future,” and similar words (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Forward-looking statements are neither historical facts nor assurances of future results, performance, events or circumstances. Instead, these forward-looking statements are based on management’s current beliefs, expectations and assumptions, and are subject to risks and uncertainties. Factors that could cause actual results to differ materially from those currently anticipated include, without limitation, risks relating to our inability to obtain adequate financing and sustain our status as a going concern; our limited operating history; our inability to generate revenues or achieve profitability;  the results of our research and development activities; our inability to achieve acceptance of our products in the market; the possibility that the anticipated benefits from business acquisitions (including the acquisition of Grinding and Dicing Services, Inc.) will not be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of acquired businesses’ operations will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the impact of a pandemic or epidemic or a natural disaster, including the COVID-19 pandemic, the Russian-Ukrainian conflict and other sources of volatility on our operations, financial condition and the worldwide economy, including its impact on our ability to access the capital markets; increases in prices for raw materials, labor, and fuel caused by rising inflation; general economic conditions, including upturns and downturns in the industry; shortages in supplies needed to manufacture our products, or needed by our customers to manufacture devices incorporating our products; our limited number of patents; failure to obtain, maintain, and enforce our intellectual property rights; claims of infringement, misappropriation or misuse of third party intellectual property, including the lawsuit filed by Qorvo, Inc. in October 2021, that, regardless of merit, could result in significant expense and negatively impact our business results; our inability to attract and retain qualified personnel; our reliance on third parties to complete certain processes in connection with the manufacture of our products; product quality and defects; existing or increased competition; our ability to successfully manufacture, market and sell products based on our technologies; our ability to meet the required specifications of customers and achieve qualification of our products for commercial manufacturing in a timely manner; our inability to successfully scale our New York wafer fabrication facility and related operations while maintaining quality control and assurance and avoiding delays in output; the rate and degree of market acceptance of any of our products; our ability to achieve design wins from current and future customers; contracting with customers and other parties with greater bargaining power and agreeing to terms and conditions that may adversely affect our business; risks related to doing business in foreign countries, including China; any security breaches, cyber-attacks or other disruptions compromising our proprietary information and exposing us to liability; our failure to innovate or adapt to new or emerging technologies, including in relation to our competitors; our failure to comply with regulatory requirements; results of any arbitration or litigation that may arise; stock volatility and illiquidity; dilution caused by any future issuance of common stock or securities that are convertible into or exercisable for common stock; our failure to implement our business plans or strategies; and our ability to maintain effective internal control over financial reporting. These and other risks and uncertainties are described in more detail in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and in subsequently filed Quarterly Reports on Form 10-Q. Considering these risks, uncertainties and assumptions, the forward-looking statements regarding future events and circumstances discussed in this document may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements included in this document speak only as of the date hereof and, except as required by law, we undertake no obligation to update publicly or privately any forward-looking statements, whether written or oral, for any reason after the date of this document to conform these statements to new information, actual results or to changes in our expectations.

Contact:

COMPANY:
Tom Sepenzis
Akoustis Technologies
VP of Corporate Development & IR
(980) 689-4961
[email protected]