TTM Technologies Aerospace & Defense Sector Awarded Contract from the U.S. Army for AN/UPR-4(V) PDRS

SANTA ANA, Calif., Aug. 30, 2023 (GLOBE NEWSWIRE) — TTM Technologies, Inc. (NASDAQ: TTMI) (“TTM”), a leading global manufacturer of technology solutions including mission systems, radio frequency (“RF”) components, RF microwave/microelectronic assemblies and printed circuit boards (“PCB”s) has received a multi-year AN/UPR-4(V) Passive Detection & Reporting System (“PDRS”) award from the U.S. Army to support their Air Missile Defense Planning and Control System (“ADMPCS”) and Integrated Battle Command System (“IBCS”). TTM has received the initial $14.7M order, with the total contract valued at $86.7M over five years.

The system meets all Department of Defense, FAA, and Eurocontrol regulations to reduce 1030 MHz/1090 MHz radio frequency transmissions and interrogation rates in air traffic and military domains.

“TTM continues to be a global leader in the design and development of cutting-edge IFF technologies, and we are proud to be supporting the U.S. Army Integrated Fires Mission Command (“IFMC”) Project Office,” says Jeff Jankowsky, President, C4ISR & Space Business Unit.

For more information, please contact:

TTM Technologies, Inc.

TTM Investors
Sameer Desai,
Vice President, Corporate Development & Investor Relations
[email protected]
714-327-3050

Press Inquiries
Aerospace & Defense Sector – Marketing & Communications
TTMA&[email protected] 

About TTM

TTM Technologies, Inc. is a leading global manufacturer of technology solutions including mission systems, RF components/RF microwave/microelectronic assemblies, quick-turn and technologically advanced PCBs. TTM stands for time-to-market, representing how TTM’s time-critical, one-stop manufacturing services enable customers to shorten the time required to develop new products and bring them to market. Additional information can be found at www.ttm.com.

Forward-Looking Statements

This release contains forward-looking statements that relate to future events or performance. TTM cautions you that such statements are simply predictions and actual events or results may differ materially. These statements reflect TTM’s current expectations, and TTM does not undertake to update or revise these forward looking statements, even if experience or future changes make it clear that any projected results expressed or implied in this or other TTM statements will not be realized. Further, these statements involve risks and uncertainties, many of which are beyond TTM’s control, which could cause actual results to differ materially from the forward-looking statements. These risks and uncertainties include, but are not limited to, the impact of COVID-19, general market and economic conditions, including interest rates, currency exchange rates and consumer spending, demand for TTM’s products, market pressures on prices of TTM’s products, warranty claims, changes in product mix, contemplated significant capital expenditures and related financing requirements, TTM’s dependence upon a small number of customers and other factors set forth in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TTM’s public reports filed with the SEC.

 



PLOS ONE Publishes Data on Allarity Therapeutics’ DRP® Companion Diagnostic for Dovitinib



– T

he
DRP
®
-Dovitinib
companion diagnostic
demonstrated an ability to
identify advanced
renal cell carcinoma
patients
that have improved clinical
benefit from dovitinib treatment
, as compared to unselected patients

BOSTON (August 30, 2023) — Allarity Therapeutics, Inc. (Allarity or the Company) (Nasdaq: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, announced today the publication of its clinical validation of a novel drug-specific DRP®-companion diagnostic (CDx) for dovitinib in the peer-reviewed journal PLOS ONE. Data showed that the DRP®-Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients. PLOS ONE published the paper online today titled, “A novel drug-specific mRNA biomarker predictor for selection of patients responding to dovitinib treatment of advanced renal cell carcinoma and other solid tumors.”

“Having our work published in PLOS ONE underscores the importance and potential impact of our DRP®-Dovitinib CDx in oncology,” said Allarity’s Chief Scientific Officer and Study Author Dr. Steen Knudsen. “This is the first validated predictive biomarker in renal cell carcinoma, a long-standing goal in potentially improving the treatment of these patients. An additional prospective trial would be required before RCC patients that are candidates for dovitinib can benefit from this diagnostic breakthrough. This DRP® publication marks yet another important step forward in Allarity’s mission to redefine cancer treatment paradigms and realize true personalized cancer care.”

Dovitinib is a pan-targeted kinase inhibitor (pan-TKI) formerly developed through Phase 3 clinical studies. The DRP®-Dovitinib CDx is a complex transcriptomic signature comprising 58 mRNA biomarkers that are collectively predictive of tumor response to the drug.   In the study evaluating pre-treatment biopsies of 135 advanced RCC patients, the DRP® positive subgroup (indicating that the patient was likely to respond) (N=49) had a median overall survival of 15 months (96% CI 12.94-26.25), whereas the DRP® negative subgroup (N=86) had a median overall survival of 9.13 months (95% CI 7.49-13.2). The hazard ratio was 0.60 (95% CI 0.39-0.91).

In addition to the 135 RCC biopsies, the DRP®-Dovitinib showed equally promising data in a number of other solid tumors, such as hepatocellular carcinoma (HCC), thereby demonstrating that it is independent of tumor type and has applicability beyond RCC.

The PLOS ONE article is Allarity’s 14th peer-reviewed publication of data from clinical validations of DRP® companion diagnostics for a range of different cancer therapeutics, further establishing the robustness of the DRP® platform.

Dovitinib has been the focus of numerous clinical studies, showing promising properties as an anti-cancer agent, but is not yet approved for the treatment of any cancer type. It is currently being advanced by Allarity in an ongoing Phase 1b clinical study exploring the potential synergy of dovitinib and stenoparib (a PARP inhibitor) for the treatment of advanced solid tumors, including ovarian cancer. In addition, in partnership with Allarity, Oncoheroes Biosciences has an ongoing program to develop dovitinib, together with the DRP®-dovitinib CDx, as a treatment for pediatric osteosarcoma.

About Allarity Therapeutics 
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP® platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer, and in Phase 1 development for advanced solid tumors in a combination treatment with dovitinib, a pan-tyrosine kinase inhibitor (pan-TKI) that has previously been developed through Phase 3 in renal cancer; and IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP®, being developed via a partnership with CHOSA Oncology AB for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the Company’s website at www.Allarity.com.

About the Drug Response Predictor – DRP® Companion Diagnostic 
Allarity uses its drug-specific DRP® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP® score, the therapeutic response rate can be significantly increased. The DRP® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP® is based on messenger RNA from patient biopsies. The DRP® platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA®. The DRP® platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in peer-reviewed literature.

Follow Allarity on
 Social Media

LinkedIn: https://www.linkedin.com/company/allaritytx/

Twitter: https://twitter.com/allaritytx

Forward-Looking Statements
 

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Allarity’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,”
“towards,”
“would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements related to the expected availability of capital to fund its anticipated clinical trials, statements related to advancing dovitinib in combination with stenoparib or another therapeutic candidate or other approved drug, any statements related to ongoing clinical trials for stenoparib as a monotherapy or in combination with another therapeutic candidate for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA
® for the treatment of metastatic breast cancer, statements relating to the effectiveness of the Company’s DRP® companion diagnostics platform in predicting whether a particular patient is likely to respond to a specific drug, and statements related to the Company’s ability to maintaincompliance with the Nasdaq Listing Rule. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for dovitinib or any of our other therapeutic candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates, and the risk that the current COVID-19 pandemic will impact the Company’s current and future clinical trials and the timing of the Company’s preclinical studies and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form 10-K annual report on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at  www.sec.gov , and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

###

Company Contact:
        [email protected]

U.S. Media Contact:
        Mike Beyer
        Sam Brown, Inc.
        +1 (312) 961-2502
        [email protected]
    

    
EU Media Contact:
        Thomas Pedersen
        Carrotize PR & Communications
        +45 6062 9390

Attachment



KULR Announces Extension of Outstanding Note

SAN DIEGO, Aug. 30, 2023 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a global leader in sustainable energy management, today announced that it has extended the initial tranche of its Note repayment to Yorkville to September 22, 2023.

Michael Mo, KULR CEO, commented: “During this period of ongoing discussions with Yorkville Advisors, we appreciate their willingness to grant an extension to the Company’s outstanding Note. In the interim, this allows management to continue to focus on operations and execution of its growth initiatives.”

About KULR Technology Group Inc.

KULR Technology Group Inc. (NYSE American: KULR) is a leading energy management platform company offering proven solutions that play a critical role in accelerating the electrification of the circular economy. Leveraging a foundation in developing, manufacturing, and licensing next-generation carbon fiber thermal management technologies for batteries and electronic systems, KULR has evolved its holistic suite of products and services to enable its customers across disciplines to operate with efficiency and sustainability in mind. For more information, please visit www.kulrtechnology.com.

Safe Harbor Statement

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. This release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our Annual Report Form 10-K filed with the Securities and Exchange Commission on March 28, 2023, as may be amended or supplemented by other reports we file with the Securities and Exchange Commission from time to time. Forward-looking statements include statements regarding our expectations, beliefs, intentions, or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. Except as required by law, we assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

Investor Relations:

KULR Technology Group, Inc.
Phone: 858-866-8478 x 847
Email: [email protected]

Media Relations:

Further PR
Email: [email protected]



Star Bulk Announces Changes to Its Board of Directors

ATHENS, Greece, Aug. 30, 2023 (GLOBE NEWSWIRE) — Star Bulk Carriers Corp. (the “Company” or “Star Bulk”) (Nasdaq: SBLK), a global shipping company focusing on the transportation of dry bulk cargoes, announced today the appointment of Mr. Ryan Lee to its Board of Directors as Class B Director and to the Nomination and Corporate Governance Committee (“the Committee”). Mr. Lee fills the seat made vacant by the resignation of Mr. Brian Laibow from the Company’s Board of Directors who has resigned in order to pursue other opportunities. Mr. Laibow was serving on the Company’s Board and was a member of the Committee since January 2020. The Company would like to thank Mr. Laibow for his commitment and invaluable services and wishes him well in his future endeavors. The newly appointed director, Mr. Ryan Lee, is a senior vice president in Oaktree’s Global Opportunities group.

About Star Bulk

Star Bulk is a global shipping company providing worldwide seaborne transportation solutions in the dry bulk sector. Star Bulk’s vessels transport major bulks, which include iron ore, minerals and grain, and minor bulks, which include bauxite, fertilizers and steel products. Star Bulk was incorporated in the Marshall Islands on December 13, 2006 and maintains executive offices in Athens, New York, Limassol, Singapore and Germany. Its common stock trades on the Nasdaq Global Select Market under the symbol “SBLK”. As of August 3, 2023 and as adjusted for the delivery of agreed to be sold vessels to their new owner, Star Bulk operates a fleet of 120 vessels, with an aggregate capacity of 13.3 million dwt, consisting of 17 Newcastlemax, 20 Capesize, 2 Mini Capesize, 7 Post Panamax, 40 Kamsarmax, 2 Panamax, 20 Ultramax and 12 Supramax vessels with carrying capacities between 52,425 dwt and 209,529 dwt.

Forward-Looking Statements

Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.

We desire to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are including this cautionary statement in connection with this safe harbor legislation. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “projects,” “likely,” “will,” “would,” “could,” “should,” “may,” “forecasts,” “potential,” “continue,” “possible” and similar expressions or phrases may identify forward-looking statements.

The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, examination by our management of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these expectations, beliefs or projections. In addition to these important factors, other important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include general dry bulk shipping market conditions, including fluctuations in charter rates and vessel values; the strength of world economies; the stability of Europe and the Euro; fluctuations in currencies, interest rates and foreign exchange rates, and the impact of the discontinuance of the London Interbank Offered Rate for US Dollars, or LIBOR, after June 30, 2023 on any of our debt referencing LIBOR in the interest rate; business disruptions due to natural disasters or other disasters outside our control, such as the ongoing novel coronavirus (“COVID-19”) pandemic (and variants that may emerge); the length and severity of epidemics and pandemics, including COVID-19 and its impact on the demand for seaborne transportation in the dry bulk sector; changes in supply and demand in the dry bulk shipping industry, including the market for our vessels and the number of new buildings under construction; the potential for technological innovation in the sector in which we operate and any corresponding reduction in the value of our vessels or the charter income derived therefrom; changes in our expenses, including bunker prices, dry docking, crewing and insurance costs; changes in governmental rules and regulations or actions taken by regulatory authorities; potential liability from pending or future litigation and potential costs due to environmental damage and vessel collisions; the impact of increasing scrutiny and changing expectations from investors, lenders, charterers and other market participants with respect to our Environmental, Social and Governance (“ESG”) practices; our ability to carry out our ESG initiatives and thereby meet our ESG goals and targets; new environmental regulations and restrictions, whether at a global level stipulated by the International Maritime Organization, and/or regional/national level imposed by regional authorities such as the European Union or individual countries; potential cyber-attacks which may disrupt our business operations; general domestic and international political conditions or events, including “trade wars” and the ongoing conflict between Russia and Ukraine; the impact on our common shares and reputation if our vessels were to call on ports located in countries that are subject to restrictions imposed by the U.S. or other governments; potential physical disruption of shipping routes due to accidents, climate-related reasons (acute and chronic), political events, public health threats, international hostilities and instability, piracy or acts by terrorists; the availability of financing and refinancing; the failure of our contract counterparties to meet their obligations; our ability to meet requirements for additional capital and financing to grow our business; the impact of our indebtedness and the compliance with the covenants included in our debt agreements; vessel breakdowns and instances of off‐hire; potential exposure or loss from investment in derivative instruments; potential conflicts of interest involving our Chief Executive Officer, his family and other members of our senior management and our ability to complete acquisition transactions as and when planned and upon the expected terms and the impact of port or canal congestion or disruptions. Please see our filings with the Securities and Exchange Commission for a more complete discussion of these and other risks and uncertainties. The information set forth herein speaks only as of the date hereof, and the Company disclaims any intention or obligation to update any forward‐looking statements as a result of developments occurring after the date of this communication.

Contacts  
   
Company: Investor Relations / Financial Media:
Simos Spyrou, Christos Begleris
Co ‐ Chief Financial Officers
Star Bulk Carriers Corp.
c/o Star Bulk Management Inc.
40 Ag. Konstantinou Av.
Maroussi 15124
Athens, Greece
Email:[email protected]
www.starbulk.com
Nicolas Bornozis
President
Capital Link, Inc.
230 Park Avenue, Suite 1536
New York, NY 10169
Tel. (212) 661‐7566
E‐mail:[email protected]
www.capitallink.com



RAPT Therapeutics to Participate in Several Upcoming Investor Conferences in September

SOUTH SAN FRANCISCO, Calif., Aug. 30, 2023 (GLOBE NEWSWIRE) — RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced that members of the RAPT management team will participate in the following investor conferences in September:

  • Wells Fargo 2023 Healthcare Conference – Fireside chat on Wednesday, September 6, 2023 at 8:00 a.m. ET

  • H.C. Wainwright 25

    th

    Annual Global Investment Conference – Presentation on Monday, September 11, 2023 at 2:00 p.m. ET

  • Stifel 2023 Immunology and Inflammation Virtual Summit – Fireside chat on Tuesday, September 19, 2023 at 3:45 p.m. ET

  • Cantor Global Healthcare Conference – Presentation on Tuesday, September 26, 2023 at 10:35 a.m. ET

To access the available live webcasts or subsequent archived recordings of the discussions and presentations, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

About RAPT Therapeutics, Inc.

RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of inflammation and cancer, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development.

Investor Contact:

Sylvia Wheeler
[email protected]

Media Contact:

Aljanae Reynolds
[email protected]



Acer Therapeutics Reacquires Worldwide Development, Commercialization and Economic Rights to OLPRUVA™ from Relief Therapeutics, Excluding the Geographical Europe

NEWTON, Mass., Aug. 30, 2023 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced it has entered into definitive agreements to reacquire worldwide development, commercialization and economic rights to OLPRUVA™ (sodium phenylbutyrate) from Relief Therapeutics, excluding the European Union, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia (Geographical Europe). OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).

Under the prior Collaboration and License Agreement (CLA) between the parties, Acer would have paid Relief 60% of Acer’s OLPRUVA™ net profits in the U.S., Canada, Brazil, Turkey and Japan (the Acer territories), while Acer would have received a 15% royalty on Relief’s net sales in the rest of the world (the Relief territories). Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe. In return, Relief will receive an upfront payment by Acer of $10 million, to be made within 5 business days of the signature date, with an additional payment of $1.5 million due on the first-year anniversary of the $10 million payment. Acer has also agreed to pay a 10% royalty on net sales in the Acer territories, and 20% of any value received by Acer from certain third parties relating to OLPRUVA™ licensing or divestment rights, all of the foregoing which are capped at $45 million, for total payments to Relief of up to $56.5 million. Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™.

“Regaining exclusive worldwide rights to OLPRUVA™ without profit sharing, subject only to Relief’s rights in the Geographical Europe, unlocks value for Acer as we continue the U.S. launch of OLPRUVA™ and begin to provide treatments to UCD patients in need,” said Chris Schelling, CEO and Founder of Acer. “Reacquiring greater economic rights to OLPRUVA™ allows Acer to reinvest more capital into potential lifecycle expansion opportunities for OLPRUVA™, in additional inborn errors of metabolism, such as Maple Syrup Urine Disease and other potential indications.”

“We are very happy to have restructured our collaboration with Acer Therapeutics which we believe will benefit those suffering from UCDs and other potential rare metabolic conditions,” said Jack Weinstein, CEO of Relief Therapeutics. “Our collective goal with Acer is to maximize the global commercialization of OLPRUVA™ to ensure as many patients as possible will access this much needed, differentiated and convenient alternative.”

Additional information regarding the termination of the March 2021 CLA and execution of the new ELA for European rights is available on form 8-K at https://www.acertx.com/investor-relations/sec-filings-list/.


OLPRUVA
: Now Available by Prescription in U.S.
ACER-001 (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and is marketed under the brand name, OLPRUVA™. OLPRUVA™ (sodium phenylbutyrate) for oral suspension is a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a BSA of 1.2 m2 or greater, with UCDs, involving deficiencies of CPS, OTC, or AS.1 Please see full Prescribing Information, including Patient Information.


Important Safety Information


Certain medicines may increase the level of ammonia in the blood or cause serious side effects when taken during treatment with OLPRUVA™. Tell your doctor about all the medicines you or your child takes, especially if you or your child takes corticosteroids, valproic acid, haloperidol, and/or probenecid.

OLPRUVA™ can cause serious side effects, including: 1) nervous system problems (neurotoxicity) such as, sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, and/or confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA™ contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA™ is right for you.

The most common side effects of OLPRUVA™ include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional Important Safety Information, see full Prescribing Information, Patient Package Insert and discuss with your doctor.

About Acer Therapeutics

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. In the U.S., OLPRUVA™ (sodium phenylbutyrate) is approved for the treatment of UCDs involving deficiencies of CPS, OTC, or AS. Acer is also advancing a pipeline of investigational product candidates for rare and life-threatening diseases, including: OLPRUVA™ (sodium phenylbutyrate) for treatment of various disorders, including Maple Syrup Urine Disease (MSUD); and EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation. For more information, visit www.acertx.com.

References

  1. OLPRUVA™ (sodium phenylbutyrate) for oral suspension. Prescribing information. Newton, MA: Acer Therapeutics Inc.

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, expected payments between Acer and Relief in connection with the ELA and terminated CLA, the impact of the revised business arrangement between Acer and Relief on the Company and the Company’s investment plans related thereto, plans with respect to the U.S. launch of OLPRUVA™, and the possible side effects of OLPRUVA™. Additionally, the Company’s effort to advance a pipeline of investigational product candidates and related plans and expectations is an example of such forward-looking statements. Our efforts to commercialize OLPRUVA™ for oral suspension in the U.S. for the treatment of certain patients with UCDs involving deficiencies of CPS, OTC, or AS are at an early stage, we currently do not have fully developed marketing and sales capabilities, and there is no guarantee that we will be successful in our commercialization efforts. Our pipeline products (including OLPRUVA™ for indications other than UCDs) are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the availability of financing to fund our commercialization efforts, our pipeline product development programs and general corporate operations as well as risks related to drug development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You may access these documents for no charge at http://www.sec.gov.

Corporate and IR Contacts

Harry Palmin
Chief Financial Officer
Acer Therapeutics Inc.
[email protected]
+1-844-902-6100

Nick Colangelo
Gilmartin Group
[email protected]
+1-332-895-3226



Titan Machinery Inc. Announces Strategic Acquisition of O’Connors

– Australia’s
leading
Case IH dealership group with strong presence in high horsepower equipment –

– Accretive acquisition generated approximately $0.40 in annual proforma earnings per share –

– Acquisition includes strong management team with track record of solid financial performance through a combination of organic and acquisitive growth –

– Updates fiscal 2024 modeling assumptions for Transaction –

WEST FARGO, N.D., Aug. 30, 2023 (GLOBE NEWSWIRE) — Titan Machinery Inc. (Nasdaq: TITN) (“Titan” or the “Company”), a leading network of full-service agricultural and construction equipment stores, announced today that it has entered into a definitive purchase agreement to acquire J.J. O’Connor & Sons Pty. Ltd. (“O’Connors”), the largest Case IH dealership group in Australia, for $63 million in cash, subject to final working capital and other closing adjustments (the “Transaction”). In the unaudited full fiscal year period ended June 30, 2023, O’Connors generated revenue of $258 million and EBITDA of $21.4 million, as translated to USD.

O’Connors, founded in 1964, is the largest Case IH dealership group in Australia, and a market leader in high horsepower equipment. O’Connors delivers a wide range of new and used equipment, parts, and services through its 15 dealerships and 1 parts location located in the Australian southeastern grain belt, which includes the regions of Victoria, New South Wales, and South Australia. In addition, O’Connors is a distributor for more than 25 leading short-line equipment brands, providing an impressive range of complementary offerings to its core Case IH line of products, and has a strong parts and service business that provides a reliable recurring revenue stream. On a consolidated basis, O’Connors achieved a gross margin of approximately 18.7% in the full fiscal year 2023, and generated a total pre-tax margin of approximately 7.2%, representing a margin profile that is consistent with Titan’s.

David Meyer, Titan Machinery’s Chairman and Chief Executive Officer, stated, “We are pleased to announce our definitive agreement to acquire O’Connors, Australia’s leading Case IH dealership group. This transaction marks our entry into the Australian agriculture market, as we continue to seek opportunities for Titan to expand its reach, both domestically and abroad. O’Connors’ operating metrics, core values, and customer-centric focus align with our own, making them a great partner for our entry into the Australian agriculture market, which is benefiting from strong fundamentals that are being driven by enhanced productivity, economies of scale, and farmer profitability.”

Mr. Meyer continued, “We are very impressed with the O’Connors senior management team, led by CEO Gareth Webb, who have been operating the business exceptionally well over the last five years after succeeding the retiring major shareholders Dennis and Mark O’Connor. It’s this strong management team, along with their great track record of retailing and supporting the high horsepower CaseIH product line up that makes this a very compelling acquisition. O’Connors has established itself as a respected leader in the region, earning a reputation for its deep expertise and employee and customer-centric focus. Their long-term business relationships, built over nearly six decades, demonstrates their commitment to excellence. The O’Connors team has a proven track record of driving organic growth, M&A execution, and profitability, and we believe that there is additional opportunity to build upon their growth formula and capitalize on operational synergies across Titan’s global footprint as we integrate the business.”

Strategic and Financial Highlights

  • Largest Case IH agriculture equipment dealership in Australia with leading market share positions in key offerings – O’Connors is the leading distributor of Case IH agricultural equipment in Australia, with a primary focus on high-horsepower cash crop production equipment. Throughout its 16 locations in the grain belt region in southeastern Australia, O’Connors provides an end-to-end offering to customers including new and used equipment, parts and services, and other value-added service offerings.
  • Key similarities to Titan’s domestic agriculture business, which will allow for seamless integration and unique synergy opportunities – O’Connors’ focus on high-horsepower cash crop production equipment in Australia’s grain belt region is being supported by the combination of increasing precision ag technology adoption and farm expansion. These trends are similar to what Titan is experiencing in its domestic agriculture business and coupled with the O’Connors’ strong management team, Australia’s native English language, and comparable legal system, this transaction is expected to allow for a seamless integration that carries over into our shared values and customer-centric focus. The Company believes it also provides Titan with unique operational synergy opportunities to expand its global customer service capabilities and capacity across the network.
  • Titan to enhance and expand upon O’Connors’ proven M&A strategy – O’Connors’ growth accelerated in 2018 following a focused acquisition strategy that resulted in acquiring nine additional locations in the subsequent five year period. The Australian market is in the early stages of dealer consolidation and through a combined approach – leveraging O’Connors’ existing leadership team and Titan’s broader capabilities and resources – the Company believes is it well positioned to capitalize on continued acquisition opportunities to unlock network synergies while driving market share gains.
  • Immediately accretive transaction with long-term growth opportunities – O’Connors’ base unaudited fiscal 2023 business, ended June 30, 2023, produced revenue of $258 million, pre-tax income of $18.7 million and EBITDA of $21.4 million. Adding estimated financing and integration expenses for the first twelve months of ownership to these results provides for run rate pro forma profit before tax of $13.0 million, or $0.40 earnings per share. The combined Titan Machinery enterprise, along with the O’Connors proforma run rate results, would equate to approximately $2.9 billion in revenue, and $5.20 in diluted earnings per share an annualized basis, based on the midpoint of Titan’s full fiscal year 2024 guidance ending in January 2024. The combined Company exhibits strong pre-tax margins and builds upon Titan’s growth strategy.

Additional Transaction Details

The definitive agreement to acquire O’Connors contemplates an acquisition price of $63 million, subject to final working capital and other closing adjustments, and will be funded with cash and Titan’s existing credit facility.

The O’Connors organization is represented by a strong, capable and professional leadership team that spearheaded its growth acceleration over the past five years. It is anticipated that Titan Machinery will retain O’Connors’ management team following the integration, who will be responsible for the region’s operating performance and report into Titan’s executive team.

The Transaction is subject to customary closing conditions and is expected to close in the fourth quarter of calendar 2023.

Fiscal 2024 Modeling Assumptions

Upon closing, the Company expects to add a fourth reporting segment to reflect the acquired Australian business and is providing incremental expectations for that segment for the balance of fiscal 2024. The table below assumes no changes to the Company’s outlook or underlying assumptions beyond the expected accretion from the Transaction in fiscal 2024. The Company will provide any further updates to its consolidated guidance when it releases financial results for the fiscal second quarter ended July 31, 2023, tomorrow, Thursday, August 31, 2023.

  Current Assumptions   Previous Assumptions
Segment Revenue      
Agriculture(1) Up 20-25%   Up 20-25%
Construction Flat – Up 5%   Flat – Up 5%
Europe (formerly “International”)(2) Up 8-13%   Up 8-13%
       
Australia (O’Connors)(3) $70-90 million    
       
Diluted EPS

(2)(4)
$4.60 – $5.25   $4.50 – $5.10
       
(1) Includes the full year impact of the Mark’s Machinery acquisition, which closed in April 2022, the Heartland Ag acquisition, which closed in August 2022, the Pioneer Farm Equipment acquisition, which closed in February 2023, and the partial year impact of the Midwest Truck acquisition, which closed in June 2023.
(2) Includes an estimated loss of approximately $0.07 per share for the Company’s Ukrainian subsidiary, which would be similar to actual results for such subsidiary in Fiscal 2023. Includes the partial year impact of the two-store acquisition in Germany, which closed in May 2023.
(3) Represents the anticipated partial year revenue impact for the O’Connors acquisition, assuming an October 2023 closing and a foreign currency translation rate of AUD $0.67 to USD $1.00.
(4) Includes the partial year EPS impact in the range of $0.10-$0.15 to account for the O’Connors acquisition net of integration and financing costs, assuming an October 2023 closing.

Supplement Presentation Information

The Company has produced a supplemental presentation to accompany this press release, which is available on the Company’s website under Investor Relations at www.titanmachinery.com.

Non-GAAP Financial Measures

This press release and the attached financial tables contain disclosure of the Company’s EBITDA, which is a non-GAAP financial measure as defined under SEC rules. As required by SEC rules, the Company has provided a reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure in the schedule included in this press release. The Company believes that presentation of this non-GAAP financial measure improves the transparency of the Company’s disclosures and provides a meaningful presentation of the Company’s results.

About Titan Machinery Inc.

Titan Machinery Inc., founded in 1980 and headquartered in West Fargo, North Dakota, owns and operates a network of full service agricultural and construction equipment dealer locations in North America and Europe, servicing farmers, contractors, ranchers and commercial applicators. The network consists of US locations in Colorado, Idaho, Iowa, Kansas, Minnesota, Missouri, Montana, Nebraska, North Dakota, South Dakota, Washington, Wisconsin and Wyoming and its European stores are located in Bulgaria, Germany, Romania, and Ukraine. The Titan Machinery locations represent one or more of the CNH Industrial Brands, including Case IH, New Holland Agriculture, Case Construction, New Holland Construction, and CNH Industrial Capital. Additional information about Titan Machinery Inc. can be found at www.titanmachinery.com.

Forward Looking Statements
Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The words “potential,” “believe,” “estimate,” “expect,” “intend,” “may,” “could,” “will,” “plan,” “anticipate,” and similar words and expressions are intended to identify forward-looking statements. These statements are based upon the current beliefs and expectations of our management. Forward-looking statements made in this release, which include statements regarding the expected impact of the O’Connors acquisition and modeling assumptions and expected results of operations for the fiscal year ending January 31, 2024 and may include statements regarding Agriculture, Construction, and International segment initiatives and improvements, segment revenue realization, growth and profitability expectations, the performance of our Ukrainian subsidiary within our International segment, agricultural equipment industry conditions and trends, involve known and unknown risks and uncertainties that may cause Titan Machinery’s actual results in future periods to differ materially from the forecasted assumptions and expected results. The Company’s risks and uncertainties include, among other things, our ability to successfully integrate and realize growth opportunities and synergies in connection with the O’Connors acquisition, and the risk that we assume unforeseen or other liabilities in connection with the O’Connors acquisition. In addition, risks and uncertainties also include the impact of the Russia-Ukraine conflict on our Ukrainian subsidiary, our substantial dependence on CNH Industrial including CNH Industrial’s ability to design, manufacture and allocate inventory to our stores necessary to satisfy our customers’ demands, supply chain disruptions impacting our suppliers, including CNH Industrial, the continued availability of organic growth and acquisition opportunities, potential difficulties integrating acquired stores, industry supply levels, fluctuating agriculture and construction industry economic conditions, the success of recently implemented initiatives within the Company’s operating segments, the uncertainty and fluctuating conditions in the capital and credit markets, difficulties in conducting international operations, foreign currency risks, governmental agriculture policies, seasonal fluctuations, the ability of the Company to manage inventory levels, weather conditions, disruption in receiving ample inventory financing, and increased competition in the geographic areas served. These and other risks are more fully described in Titan Machinery’s filings with the Securities and Exchange Commission, including the Company’s most recently filed Annual Report on Form 10-K, as updated in subsequently filed Quarterly Reports on Form 10-Q, as applicable. Titan Machinery conducts its business in a highly competitive and rapidly changing environment. Accordingly, new risks and uncertainties may arise. It is not possible for management to predict all such risks and uncertainties, nor to assess the impact of all such risks and uncertainties on Titan Machinery’s business or the extent to which any individual risk or uncertainty, or combination of risks and uncertainties, may cause results to differ materially from those contained in any forward-looking statement. Other than as required by law, Titan Machinery disclaims any obligation to update such risks and uncertainties or to publicly announce results of revisions to any of the forward-looking statements contained in this release to reflect future events or developments.

Investor Relations Contact:

ICR, Inc.
Jeff Sonnek, [email protected]
646-277-1263

TITAN MACHINERY INC.
Non-GAAP Reconciliation for O’Connors
(in thousands)
(Unaudited)
   
  Fiscal Year ended



June 30, 2023
 
Net Income $ 13,060
Adjustments  
Interest expense, net of interest income   1,417
Taxes   5,592
Depreciation and Amortization   1,299
EBITDA $ 21,368

 



Sana Biotechnology to Present at September 2023 Investor Conferences

SEATTLE, Aug. 30, 2023 (GLOBE NEWSWIRE) — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that it will webcast its presentations at five investor conferences in September. The presentations will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer, and Nate Hardy, Sana’s Chief Financial Officer.

  • Steve Harr will present at Citi’s 18th Annual BioPharma Conference at 10:30 a.m. ET on Wednesday, September 6, 2023.
  • Steve Harr will present at the 2023 Wells Fargo Healthcare Conference at 2:15 p.m. ET on Thursday, September 7, 2023.
  • Nate Hardy will present at the HC Wainwright 25th Annual Global Investment Conference at 10:00 a.m. ET on Monday, September 11, 2023.
  • Steve Harr will present at the Morgan Stanley 21st Annual Healthcare Conference at 1:35 p.m. ET on Tuesday, September 12, 2023.
  • Nate Hardy will present at the 2023 Cantor Global Healthcare Conference at 10:55 a.m. ET on Wednesday, September 27, 2023.

The webcasts will be accessible on the Investor Relations page of Sana’s website at https://sana.com/. A replay of each presentation will be available at the same location for 30 days following the corresponding conference.

About Sana Biotechnology

Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester. For more information about Sana Biotechnology, please visit https://sana.com/.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision; the Company’s participation at Citi’s 18th Annual BioPharma Conference, the 2023 Wells Fargo Healthcare Conference, the HC Wainwright 25th Annual Global Investment Conference, the Morgan Stanley 21st Annual Healthcare Conference, and the 2023 Cantor Global Healthcare Conference; and the subject matter of the Company’s presentations at those conferences. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market and social disruptions, including due to the COVID-19 public health crisis. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Quarterly Report on Form 10-Q dated August 3, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Investor Relations & Media:

Nicole Keith
[email protected]
[email protected]



Pulmonx to Participate at Upcoming Investor Conferences

REDWOOD CITY, Calif., Aug. 30, 2023 (GLOBE NEWSWIRE) — Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”) a global leader in minimally invasive treatments for severe lung disease, today announced the company will be participating in two upcoming investor conferences.

Pulmonx management is scheduled to participate in a fireside chat at the 2023 Wells Fargo Healthcare Conference in Boston on Wednesday, September 6, 2023, at 11:15am PT / 2:15pm ET. Interested parties may access a live and archived webcast of the event on the “Investors” section of the Pulmonx website at https://investors.pulmonx.com/.

Pulmonx management will also be participating in investor meetings at the Morgan Stanley 21st Annual Global Healthcare Conference in New York on Wednesday, September 13, 2023.

About Pulmonx Corporation

Pulmonx Corporation (Nasdaq: LUNG) is a global leader in minimally invasive treatments for severe lung disease. Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who despite medical management are still profoundly symptomatic. Pulmonx received FDA premarket approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, with over 100,000 valves used to treat more than 25,000 patients. For more information on the Zephyr Valves and the company, please visit www.Pulmonx.com.

Pulmonx®, Chartis®, StratX®, and Zephyr® are registered trademarks of Pulmonx Corporation.

Contact

Brian Johnston
Gilmartin Group
[email protected]



Allakos Appoints Neil Graham to its Board of Directors

SAN CARLOS, Calif., Aug. 30, 2023 (GLOBE NEWSWIRE) — Allakos Inc. (Nasdaq: ALLK), a clinical-stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases, today announced the appointment of Neil Graham, M.D. to the Allakos board of directors.

Dr. Graham was the Chief Medical Officer of Tiziana Life Sciences Limited and currently serves on the board of directors of Aslan Pharmaceuticals Limited, Pharmaxis Limited and Zura Bio Limited. Among other experiences, Dr. Graham was the Vice President of Strategic Program Direction, Immunology and Inflammation at Regeneron Pharmaceuticals, Inc. and he received his M.D. from the University of Adelaide.

About Allakos

Allakos is a clinical stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The Company’s most advanced antibodies are lirentelimab (AK002) and AK006. Lirentelimab selectively targets both mast cells and eosinophils, two types of white blood cells that are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells and eosinophils have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. AK006 targets Siglec-6, an inhibitory receptor expressed selectively on mast cells. In pre-clinical studies, AK006 appears to provide deeper mast cell inhibition than lirentelimab and, in addition to its inhibitory activity, reduce mast cell numbers. For more information, please visit the Company’s website at www.allakos.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, statements regarding the clinical potential of Allakos’ antibodies. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos’ stages of clinical drug development; Allakos’ ability to timely initiate and complete clinical trials for lirentelimab and AK006; Allakos’ ability to obtain required regulatory approvals for its clinical trials; uncertainties related to the enrollment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of clinical trials, regardless of the outcomes of preclinical testing or early-stage trials; Allakos’ ability to obtain regulatory approvals to market its product candidates; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos’ ability to advance additional product candidates beyond lirentelimab; Allakos’ ability to obtain additional capital to finance its operations, research and drug development; general economic and market conditions, both domestic and international; domestic and international regulatory obligations; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Allakos files from time to time to with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release.

Source: Allakos Inc.

Investor Contact:
Adam Tomasi, President
Alex Schwartz, VP Strategic Finance and Investor Relations
[email protected]

Media Contact:
Denise Powell
[email protected]