Arcellx to Participate in Two Upcoming Investor Conferences

On October 26, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that the management team will participate in two upcoming investor conferences (Press release, Arcellx, OCT 26, 2023, View Source [SID1234636391]):

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TD Cowen 7th Annual Fall Oncology Innovation Summit (Virtual)
Fireside Chat: Friday, November 3 at 12:30 p.m. ET

Stifel 2023 Healthcare Conference, New York, NY (In Person)
Fireside Chat: Wednesday, November 15 at 1:15 p.m. ET

A live webcast of these discussions will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcasts will be archived and available for 30 days following the event.

West Announces Third-Quarter 2023 Results, Updates Full-Year 2023 Guidance and Declares Fourth-Quarter 2023 Dividend

On October 26, 2023 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2023, updated full-year 2023 financial guidance and declared a fourth-quarter 2023 dividend (Press release, West Pharmaceutical Services, OCT 26, 2023, View Source;utm_medium=Email&utm_campaign=Investors_Email&campaignid=null&utm_content=23_October_2023&utm_term=null&creative=null&device=null&matchtype=null#2023-oct-26-west-announces-third-quarter-2023-results-updates-full-year-2023-guidance-and-declares-fourth-quarter-2023-dividend [SID1234636390]).

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Third-Quarter 2023 Summary (comparisons to prior-year period)

Net sales of $747.4 million grew 8.8%; organic net sales growth was 5.7%.
Reported-diluted EPS of $2.14 increased 34.6%.
Adjusted-diluted EPS of $2.16 increased 6.4%.
Company is updating full-year 2023 net sales guidance to a new range of $2.950 billion to $2.960 billion, compared to a prior range of $2.970 billion to $2.995 billion.
Company is updating full-year 2023 adjusted-diluted EPS guidance to a new range of $7.95 to $8.00, compared to a prior range of $7.65 to $7.80.
The Company also announced that its Board of Directors has approved a fourth-quarter 2023 dividend of $0.20 per share, a 5.3% increase over the $0.19 per share paid in each of the four preceding quarters. This is the thirty-first consecutive annual increase in the Company’s dividend. The dividend will be paid on November 15, 2023, to shareholders of record as of November 8, 2023.
"Adjusted-diluted EPS" and "organic net sales" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"We had a solid quarter of organic net sales growth, driven by our Proprietary Products’ high-value product (HVP) and strong Contract Manufacturing components," said Eric M. Green, President, Chief Executive Officer and Chair of the Board. "We are observing a slowdown in restocking trends by large Pharma and Generic customers, which is reflected in our revised guidance. As we look to the fourth-quarter 2023, we anticipate double-digit base, non-COVID-19-related organic sales growth, fueled by strong HVP component demand with certain customers and therapeutic categories."

Proprietary Products Segment
Net sales grew by 6.3% to $602.5 million. Organic net sales growth (excluding changes in currency translation and the impact of a recent divestiture) was 3.2%, with currency translation increasing net sales growth by 250 basis points. HVP net sales represented over 75% of segment net sales and generated mid-single digit organic net sales growth, led by customer demand for HVP components such as FluroTec, Daikyo and Envision as well as HVP devices such as self-injection systems and administration systems.

The Generics market unit had high-single digit organic net sales growth, and the Biologics and Pharma market units had low-single digit organic net sales growth. As expected, sales related to COVID-19 continued to decline from the same period last year. Excluding this COVID-19 impact, the Proprietary Products segment organic sales would have grown double-digits, led by Biologics and Generics market units.

Contract-Manufactured Products Segment
Net sales grew by 20.8% to $144.9 million. Organic net sales growth was 17.4% with currency translation increasing net sales growth by 340 basis points. Segment performance was led by growth in sales of components for drug-injection devices and for healthcare diagnostic devices.

Financial Highlights (first nine months of 2023)
Operating cash flow was $537.4 million, an increase of 9.0%. Capital expenditures were $253.3 million, an increase of 33.5% over the same period last year. Free cash flow (operating cash flow minus capital expenditures) was $284.1 million, a decline of 6.4%.

During the first nine months of 2023, the Company repurchased 753,399 shares for $261.3 million at an average share price of $346.86 under its share repurchase program.

Full-Year 2023 Updated Financial Guidance

The Company is updating full-year 2023 net sales guidance to be a new range of $2.950 billion to $2.960 billion, compared to a prior range of $2.970 billion to $2.995 billion.
Organic net sales growth guidance is a range of 2% to 3%, compared to prior guidance of a range of 3% to 4%.
Net sales guidance assumes COVID-19 related sales of approximately $68 million, compared to prior guidance of $60 million.
Net sales guidance includes an estimated full-year 2023 tailwind of $20 million based on current foreign currency exchange rates, unchanged from prior guidance.
Net sales guidance also includes a reduction of $8 million resulting from a divestiture of a European facility that produced standard Proprietary Product components, unchanged from prior guidance.
Full-year 2023 adjusted-diluted EPS is expected to be in a range of $7.95 to $8.00, compared to prior guidance range of $7.65 to $7.80.
Full-year adjusted-diluted EPS guidance range includes a tailwind of approximately $0.07 based on current foreign currency exchange rates, compared to prior guidance of a tailwind of $0.05.
The updated guidance also includes EPS of $0.41 associated with first nine-months 2023 tax benefits from stock-based compensation.
For the fourth-quarter 2023, our EPS guidance range assumes a tax rate of 22% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first nine months of 2023 would provide a positive adjustment to our full-year adjusted-diluted EPS guidance.
Full-year 2023 capital spending guidance is unchanged and is expected to be $350 million. This includes incremental capital spending to support capacity expansions at existing HVP facilities.
Third-Quarter 2023 Conference Call
The live audio-only webcast will be made available via the Company’s Investor Relations website here or by clicking here.

To participate in the conference call by asking questions to Management, please register in advance by clicking here. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that will be used to access the call.

Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

A replay of the conference call and webcast will be available on the Company’s website for 30 days.

Vertex to Present at Upcoming Investor Conferences

On October 26, 2023 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported management participation in two upcoming investor conferences (Press release, Vertex Pharmaceuticals, OCT 26, 2023, View Source [SID1234636389]).

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Charles Wagner, Executive Vice President and Chief Financial Officer, and David Altshuler, M.D., Ph.D., Executive Vice President, Global Research, and Chief Scientific Officer, will participate in a fireside chat at UBS Biopharma Conference on Thursday, November 9, 2023 at 12:00 p.m. ET.

Stuart Arbuckle, Executive Vice President and Chief Operating Officer, will participate in a fireside chat at Jefferies London Healthcare Conference on Tuesday, November 14, 2023 at 8:30 a.m. GMT.

A live webcast of management’s remarks will be available through the Vertex website, www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

Triumvira Immunologics Announces First Patient Dosed in Phase II of TACTIC-2 Cell Therapy Trial for the Treatment of HER2+ Gastric and GEJ Cancers

On October 26, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that the first patient has been dosed in Phase II of its Phase I/II study TACTIC-2 (NCT04727151) investigating the safety and efficacy of autologous TAC-T cell lead asset, TAC01-HER2, in targeting HER2 in relapsed or refractory gastric and gastroesophageal junction (GEJ) tumors (Press release, Triumvira Immunologics, OCT 26, 2023, View Source [SID1234636387]). TAC01-HER2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

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"This marks a significant milestone for our company, building upon the determination of the recommended Phase II dose, identifying gastric and gastroesophageal cancer patients as targets for the Phase II registration supporting study and the positive benefit we observed during the Phase I part of TACTIC-2," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "Despite considerable advances in the oncology field, HER2-positive gastric and gastro-esophageal cancers remain difficult to treat, and new therapeutic options are urgently needed especially in later treatment lines in a growing patient segment. Our TAC technology offers a novel approach that works by leveraging the natural signaling pathways of endogenous TCRs and modifying T cells into TAC T cells with demonstrated success in the treatment of these tumors. We are committed to providing clinically meaningful therapeutic benefits to this patient population with high unmet medical needs."

TACTIC-2 is an open-label, multicenter Phase I/II study that aims to establish safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma.

Theratechnologies Announces Pricing of US$25 Million Public Offering of Common Shares and Concurrent Private Placement

On October 26, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (Nasdaq: THTX; TSX: TH), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has priced its previously announced public offering (the "Public Offering") of 12,500,000 common shares of the Company (the "Common Shares") at a public offering price of US$1.00 per Common Share (the "Offering Price") (Press release, Theratechnologies, OCT 26, 2023, View Source [SID1234636386]). The gross proceeds of the Public Offering are expected to be approximately US$12,500,000, before deducting the underwriting discounts and commissions and other estimated offering expenses. The Company has also granted the underwriter a 30-day option (the "Option") to purchase up to 1,875,000 Common Shares at the Offering Price, less underwriting discounts and commissions.

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Cantor Fitzgerald & Co. is acting as sole bookrunner for the Public Offering.

In connection with the Public Offering, the Company entered into a subscription agreement with Investissement Québec for a concurrent private placement (the "Concurrent Private Placement") of 9,118,184 Common Shares and 3,381,816 fully-funded, non-voting subscription receipts, exchangeable into Common Shares on a one-for-one basis (the "Exchangeable Subscription Receipts") in lieu of Common Shares, in each case, at the Offering Price, for US$12,500,000 aggregate gross proceeds, less a capital commitment fee of 1.5% payable to Investissement Québec. The component of the Concurrent Private Placement in the form of Exchangeable Subscription Receipts is designed to ensure that, following completion of the Public Offering and the Concurrent Private Placement, Investissement Québec does not have beneficial ownership or control over more than 19.9% of the issued and outstanding Common Shares and therefore is not a "control person" within applicable Canadian securities laws.

The Company will also enter into an investor rights agreement, pursuant to which Investissement Québec will be entitled to nominate one director to the Company’s board of directors for as long as it holds 50% of the Common Shares purchased pursuant to the Concurrent Private Placement. Copies of the subscription agreement, the exchangeable receipt agreement setting forth the terms and condition of the Exchangeable Subscription Receipts and the investor rights agreement, when available, will be filed on SEDAR+ at www.sedarplus.ca. Summaries of the subscription agreement and the exchangeable receipt agreement and a copy of the investor rights agreement, when available, will be filed on EDGAR at www.sec.gov.

Assuming completion of the Public Offering and the Concurrent Private Placement for US$12,500,000 and US$12,500,000 aggregate gross proceeds, respectively, but assuming that the Option is not exercised, Investissement Québec will beneficially own approximately 19.9% (25.4% if the Exchangeable Subscription Receipts were to be exchanged into Common Shares) of the issued and outstanding Common Shares as of the date of closing. If the Option is exercised in full, Investissement Québec will beneficially own approximately 19.1% (24.5% if the Exchangeable Subscription Receipts were to be exchanged into Common Shares) of the issued and outstanding Common Shares as of the date of closing.

A preliminary prospectus supplement (the "Prospectus Supplement") to the Company’s short form base shelf prospectus dated December 14, 2021 (the "Base Shelf Prospectus") was filed with the securities regulatory authorities in each of the provinces of Canada as well as with the U.S. Securities and Exchange Commission (the "SEC") as part of its registration statement on Form F-10 (the "Registration Statement") under the U.S.-Canada multijurisdictional disclosure system ("MJDS"). The Public Offering will be made in Canada only pursuant to the Prospectus Supplement and Base Shelf Prospectus and in the United States only pursuant to the Registration Statement, containing the Prospectus Supplement and the Base Shelf Prospectus, filed with the SEC under the MJDS. Copies of the Prospectus Supplement and the Base Shelf Prospectus are available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov, and a copy of the Registration Statement is available on EDGAR at www.sec.gov. Copies may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by e-mail at [email protected].

Completion of the Public Offering and Concurrent Private Placement is expected to occur by October 31, 2023, subject to customary closing conditions, including the listing of the Common Shares, and the Common Shares underlying the Exchangeable Subscription Receipts, on the Toronto Stock Exchange and the submission of notice to the Nasdaq Capital Market. The closing of the Public Offering and the Concurrent Private Placement are conditional upon each other.

The Company intends to use the net proceeds of the Public Offering and the Concurrent Private Placement for general corporate purposes, which may include working capital, general and administrative expenses, commercialization expenses, repayment of outstanding debt under its credit facility with certain funds and accounts for which Marathon Asset Management, L.P. acts as investment manager, and potential acquisitions or in-licensing of commercial products.

Prospective investors should read the Prospectus Supplement, Base Shelf Prospectus and Registration Statement before making an investment decision.

No securities regulatory authority has either approved or disapproved the contents of this news release. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.