On May 3, 2022 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and financial results for the first quarter ending March 31, 2022 (Press release, PTC Therapeutics, MAY 3, 2022, View Source [SID1234613404]).

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"We are continuing to build a robust pipeline of potential new therapeutics that at steady state we anticipate delivering a new product every 2-3 years," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "With multiple ongoing registration-directed trials, we are well on the way to fulfill this vision."

Key First Quarter Corporate Updates:
The Duchenne muscular dystrophy (DMD) franchise continued to show strong growth, with total net product revenue of $128 million for Translarna (ataluren) and Emflaza (deflazacort) in the first quarter of 2022.
Translarna total net product revenue of $79 million, with growth coming from new patients in existing markets and continued geographic expansion as PTC drives its robust and globally diversified business.
Emflaza total net product revenue of $49 million, with growth driven by continued increases in new patients and high compliance and appropriate weight-based dosing.
Evrysdi (risdiplam) net sales in the first quarter of 2022 resulted in $19 million in royalty revenue to PTC. Evrysdi is a product of the SMA collaboration among PTC, the SMA Foundation and Roche.
First Quarter Clinical Updates:
The PIVOT-HD Phase 2 study of PTC518 for the treatment of Huntington’s disease was initiated in the first quarter of 2022.
In April, Scientific Advisory Group and Oral Explanation meetings with the CHMP were successfully completed. The CHMP opinion on the PTC-AADC marketing authorization application is now expected in May 2022.
PTC expects to submit the BLA for PTC-AADC in AADC deficiency to the FDA in the third quarter of 2022.
PTC anticipates reporting results of Study 041 for ataluren by the end of the second quarter of 2022, after data analysis is completed.
PTC continues to make progress in three additional ongoing registration-directed clinical studies:
The MIT-E Phase 2/3 vatiquinone trial for mitochondrial disease associated seizures, with results anticipated in the fourth quarter of 2022.
The MOVE-FA Phase 3 vatiquinone trial for Friedreich ataxia, with results anticipated in the second quarter of 2023.
The APHENITY Phase 3 trial of PTC923 for PKU, with results anticipated by the end of this year.
Two additional registration-directed trials were initiated:
The CardinALS Phase 2 trial of PTC857 for the treatment of ALS.
The SUNRISELMS Phase 2 trial of unesbulin for the treatment of leiomyosarcoma.
First Quarter 2022 Financial Highlights:
Total revenues were $148.7 million for the first quarter of 2022, compared to $117.9 million for the first quarter of 2021.
Total revenues included net product revenue across the commercial portfolio of $129.8 million for the first quarter of 2022, compared to $91.3 million for the first quarter of 2021. Total revenues also included collaboration and royalty revenue of $18.9 million in the first quarter of 2022, compared to $26.7 million for the first quarter of 2021.
Translarna net product revenues were $79.2 million for the first quarter of 2022, compared to $46.5 million for the first quarter of 2021. These results reflect an increase in net product sales in existing markets as well as continued geographic expansion.
Emflaza net product revenues were $48.6 million for the first quarter of 2022, compared to $43.5 million for the first quarter of 2021. These results reflect continued addition of new patients, continued high compliance and appropriate weight-based dosing.
Roche reported Evrysdi sales of approximately CHF 226 million for the first quarter of 2022, resulting in royalty revenue of $18.9 million to PTC in the first quarter of 2022, as compared to $6.7 million for the first quarter of 2021. In the first quarter of 2021, the first commercial sale of Evrysdi in the EU triggered a $20 million milestone payment to PTC. This 2021 achievement was reported as collaboration revenue.
Based on U.S. GAAP (Generally Accepted Accounting Principles) R&D expenses were $140.1 million for the first quarter of 2022, compared to $134.5 million for the first quarter of 2021. The increase reflects additional investment in research programs and advancement of the clinical pipeline.
Non-GAAP R&D expenses were $127.0 million for the first quarter of 2022, excluding $13.0 million in non-cash, stock-based compensation expense, compared to $120.8 million for the first quarter of 2021, excluding $13.7 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $73.3 million for the first quarter of 2022, compared to $61.1 million for the first quarter of 2021. The increase reflects our continued investment to support commercial activities, including expanding our commercial portfolio.
Non-GAAP SG&A expenses were $59.7 million for the first quarter of 2022, excluding $13.6 million in non-cash, stock-based compensation expense, compared to $49.1 million for the first quarter of 2021, excluding $12.0 million in non-cash, stock-based compensation expense.
The change in the fair value of deferred and contingent consideration was $11.7 million for the first quarter of 2022, compared to $0.1 million for the first quarter of 2021. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
The net loss was $126.7 million for the first quarter of 2022, compared to a net loss of $128.6 million for the first quarter of 2021.
Cash, cash equivalents, and marketable securities were $587.8 million on March 31, 2022, compared to $773.4 million at December 31, 2021.
Shares issued and outstanding as of March 31, 2022 were 71,337,041.
PTC Reaffirms 2022 Financial Guidance:
PTC anticipates total revenues for full year 2022 to be between $700 and $750 million.
PTC anticipates net product revenues for the DMD franchise for full year 2022 to be between $475 and $495 million.
PTC anticipates GAAP R&D and SG&A expenses for full year 2022 to be between $915 and $965 million.
PTC anticipates Non-GAAP R&D and SG&A expense for full year 2022 to be between $800 and $850 million, excluding estimated non-cash, stock-based compensation expense of $115 million.
Non-GAAP Financial Measures:
In this press release, the financial results of PTC are provided in accordance with GAAP and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating performance of PTC and the company’s future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the table below.

Today’s Conference Call and Webcast Reminder:
PTC will host a conference call to discuss the first quarter corporate updates and financial results today at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 9963177. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

On May 3, 2022 PharmaMar (MSE:PHM) reported that Clinical Cancer Research, the journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), has published the manuscript titled "Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study", led by Vivek Subbiah M.D. (MD at the Anderson Cancer Center, Houston, USA) (Press release, PharmaMar, MAY 3, 2022, View Source [SID1234613403]). The manuscript is available at View Source

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This abstract shows the results of the 28-patient cohort of adult patients with relapsed Ewing Sarcoma from the single-arm, open-label, basket phase II clinical trial with single-agent lurbinectedin.

The trial achieved its primary endpoint of Overall Response Rate (ORR) of 14.3%, with a median Duration of Response (DoR) of 4.2 months. In addition, other secondary endpoints such as a median Progression-Free Survival (PFS) of 2.7 months, a clinical benefit ratio of 39.3% and a disease control ratio of 57.1% were achieved.

The abstract concludes "lurbinectedin was active in the treatment of relapsed Ewing Sarcoma and had a manageable safety profile. Lurbinectedin could represent a valuable addition to therapies for Ewing Sarcoma, and is currently being evaluated in combination with irinotecan in advanced Ewing Sarcoma in a phase Ib/II trial."

According to Ali Zeaiter M.D., Director of Clinical Development at PharmaMar,

"Ewing sarcoma is an aggressive disease afflicting primarily children through to young adults under 20 years of age, so it is a particular unmet medical need in this regard with no established treatment for relapsed disease. This study has shown encouraging activity in this setting with a manageable safety profile and we are continuing to explore the potential of lurbinectedin in this setting."

On May 3, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the first quarter ended April 3, 2022 (Press release, PerkinElmer, MAY 3, 2022, View Source [SID1234613402]).

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The Company reported GAAP earnings per share from continuing operations of $1.40, as compared to GAAP earnings per share from continuing operations of $3.37 in the same period a year ago. GAAP revenue for the quarter was $1.26 billion, as compared to $1.31 billion in the same period a year ago. GAAP operating income from continuing operations for the quarter was $255 million, as compared to $468 million for the same period a year ago. GAAP operating profit margin was 20.2% as a percentage of revenue, as compared to 35.8% in the same period a year ago.

Adjusted earnings per share from continuing operations for the quarter was $2.41, as compared to $3.72 in same period a year ago. Adjusted revenue for the quarter was $1.26 billion, as compared to $1.31 billion in the same period a year ago. Adjusted operating income from continuing operations for the quarter was $410 million, as compared to $542 million for the same period a year ago. Adjusted operating profit margin was 32.5% as a percentage of adjusted revenue, as compared to 41.4% in the same period a year ago.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"The company once again demonstrated its agility and resiliency so far in 2022, and I’m encouraged by our better-than-expected performance to start the year," said Prahlad Singh, president and chief executive officer of PerkinElmer. "My appreciation goes to all our employees who are not only continuing to execute at a high level for our customers, but who also are making a difference in their communities during these extraordinary times."

Financial Overview by Reporting Segment for the First Quarter

Discovery & Analytical Solutions

First quarter 2022 revenue was $602 million, as compared to $455 million in the same period a year ago. Reported revenue increased 33% and organic revenue increased 12% as compared to the same period a year ago.
First quarter 2022 operating income from continuing operations was $15 million, as compared to $43 million for the same period a year ago.
First quarter 2022 adjusted operating income was $127 million, as compared to $76 million for the same period a year ago.
Diagnostics

First quarter 2022 revenue was $657 million, as compared to $853 million for the same period a year ago. Reported revenue decreased 23% and organic revenue decreased 24% as compared to the same period a year ago.
First quarter 2022 operating income from continuing operations was $258 million, as compared to $441 million for the same period a year ago.
First quarter 2022 adjusted operating income was $301 million, as compared to $483 million for the same period a year ago.
Initiates Second Quarter and Raises Full Year 2022 Guidance

For the second quarter of 2022, the Company forecasts revenue of approximately $1.20-1.22 billion which includes the recognition of approximately $100 million of additional deferred revenue. Adjusted earnings per share in the second quarter of 2022 is expected to be in a range $2.00-2.05 which includes approximately $0.35 of earnings per share from the net impact of the recognition of deferred revenue and related costs.

For the full year 2022, the Company now forecasts revenue of $4.56-4.63 billion and adjusted earnings per share of $7.15-7.45.

Guidance for the second quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Conference Call and Webcast Information

The Company will discuss its first quarter 2022 results and its outlook for business trends during a conference call on May 3, 2022 at 5:00 p.m. Eastern Time. A live audio webcast of the call will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

On May 3, 2022 Heat Biologics, Inc. / NightHawk Biosciences (NYSE American: HTBX; NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that it has completed its name change from Heat Biologics, Inc. to NightHawk Biosciences, Inc. to better reflect the Company’s evolution, including expansion of the therapeutic pipeline, vertical integration of capabilities from drug discovery to manufacturing and commercialization, as well as the Company’s new biodefense capabilities (Press release, NightHawk Biosciences, MAY 3, 2022, View Source [SID1234613401]). In connection with the name change, the Company’s ticker will change to "NHWK," effective today, May 3, 2022. The name and symbol changes do not affect the Company’s share structure or the rights of the Company’s shareholders, and no further action is required by existing shareholders.

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Jeff Wolf, CEO of Nighthawk, commented, "The NightHawk brand better reflects our evolution towards a fully integrated ecosystem, designed to efficiently move drugs from discovery through commercialization. The NightHawk ecosystem includes an expanded development pipeline, new biodefense capabilities and enhanced manufacturing capabilities. As a result, we have organized the Company around five key subsidiaries: Skunkworx Bio, Heat Biologics, Pelican Therapeutics, Elusys Therapeutics and Scorpion Biological Services. NightHawk is laser focused on addressing key industry challenges, including the slow pace and high cost of new drug development through a fully integrated ecosystem of drug discovery, preclinical testing and manufacturing. We look forward to progressing these efforts under the NightHawk banner."

On May 3, 2022 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended March 31, 2022 (Press release, MacroGenics, MAY 3, 2022, View Source [SID1234613400]).

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"We are very pleased by the progress made during the first quarter. Our recent end of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) regarding MGC018, our B7-H3-directed antibody-drug conjugate (ADC), marks a significant milestone for the Company. Our current Phase 2/3 clinical plan for MGC018 reflects our productive dialogue with the FDA and feedback received on key elements of the program. We are targeting commencement of enrollment of the Phase 2/3 study by year-end," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Other exciting developments include the initiation of a Phase 1 dose escalation study of MGC018 in combination with lorigerlimab in advanced solid tumors and FDA clearance of the IND for MGD024, our investigational next-generation CD123 × CD3 DART molecule, enabling MacroGenics to proceed with the planned initiation of a clinical trial in CD123-positive neoplasms, including acute myeloid leukemia (AML) in mid-2022."

Updates on Proprietary Investigational Programs

B7-H3 Programs: MacroGenics is developing two clinical product candidates that target B7-H3, an antigen with broad expression across multiple solid tumor types and a member of the B7 family of molecules involved in immune regulation. Recent highlights for these two molecules include:

MGC018 is an ADC that targets B7-H3.
Following a constructive FDA meeting in March 2022, MacroGenics finalized the Phase 2/3 study design of MGC018 in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 2/3 study is designed to enroll patients with mCRPC who have had prior exposure to a taxane and at least one androgen receptor axis-targeted, or ARAT, agent (including abiraterone, enzalutamide or apalutimide), and a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, if appropriate. During the Phase 2 portion of the study, approximately 150 patients are expected to be randomized 1:1:1 to receive either 2.0 mg/kg or 2.7 mg/kg of MGC018 every four weeks in the experimental groups or physician’s choice of an ARAT agent not previously received in the control group. These lower doses compare to the starting dose of 3.0 mg/kg every three weeks (and any subsequent reductions) evaluated in the Phase 1 dose expansion study and are based on modelling and simulation of patient pharmacokinetic and safety data generated across dose expansion cohorts to date. The Company anticipates that the lower doses will decrease both the frequency and severity of adverse events and potentially improve efficacy by allowing patients to stay on therapy longer.

The Company expects analysis of the data to be performed upon completion of the Phase 2 portion of the study. In the Phase 3 portion, MacroGenics plans to randomize additional patients 1:1 to receive either MGC018 at the recommended dose or an ARAT agent for the control group. The inclusion of the Phase 2 interim analysis to evaluate the two MGC018 dose levels will allow the Company to further assess safety, tolerability and futility before proceeding to the Phase 3 portion of the study. The primary endpoint of the study will be radiographic progression-free survival (rPFS) and key secondary endpoints include objective response rate (ORR) and overall survival (OS). The Company expects to begin enrollment by year-end 2022.
MacroGenics’ Phase 1/2 expansion study of MGC018 is fully enrolled for patients with mCRPC (n=40) and smaller cohorts of patients (n=approximately 20 each) with non-small cell lung cancer (NSCLC), melanoma and triple negative breast cancer (TNBC), while the Company continues to recruit patients for the squamous cell carcinoma of the head and neck (SCCHN) cohort. The Company is encouraged by initial clinical activity observed in patients with melanoma and plans to recruit 20 additional melanoma patients in its ongoing dose expansion study, evaluating a dose of 2.7 mg/kg administered every four weeks. As for the other tumor types enrolled in the expansion study, the Company is evaluating possible next steps for enrolling additional patients with NSCLC. MacroGenics does not plan to proceed with advancing the study in patients with TNBC at this time. The Company intends to provide an update on clinical data from patients in the Phase 1/2 dose expansion study in the second half of 2022.
MacroGenics recently dosed the first patient in a Phase 1 dose escalation study of MGC018 in combination with lorigerlimab in patients with various advanced solid tumors.
Finally, in April, MacroGenics presented a poster titled "Targeting B7-H3 in Prostate Cancer: Preclinical Proof-of-Concept with MGC018, an Investigational Anti-B7-H3 Antibody-Drug Conjugate," at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual meeting. MGC018 demonstrated anti-tumor effects toward prostate cancer cell lines and enhanced activity in some lines when combined with PARP or androgen-receptor inhibitors.
Enoblituzumab is an Fc‐engineered, monoclonal antibody that targets B7‐H3.
MacroGenics continues to recruit patients into its Phase 2 study of enoblituzumab in front-line patients with SCCHN, in which PD-L1 positive patients receive combination therapy with retifanlimab (anti-PD-1 antibody) and PD-L1 negative patients receive combination therapy with tebotelimab (PD-1 x LAG-3 DART molecule). The Company expects to complete enrollment of the PD-L1 positive patient cohort during the first half of this year and provide an update on this cohort during the second half of the year.
Updated study results from an earlier Phase 1 study of the combination of enoblituzumab and pembrolizumab in advanced B7-H3-expressing solid tumors was published in the Journal for ImmunoTherapy of Cancer in April (data cut-off: March 14, 2019). This combination was well tolerated and demonstrated objective responses in 6 of 18 patients (33.3%) with SCCHN who were checkpoint-naïve and had previously progressed after receiving first-line platinum-based chemotherapy. The updated published data showed a median OS of 17.4 months (95% CI: 9.2 to NR) in patients with SCCHN. These encouraging findings helped guide our current development strategy for enoblituzumab.
DART Molecules for Immune Checkpoint Blockade: MacroGenics is studying multiple PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable combination opportunities across the Company’s portfolio. Recent highlights for one of these molecules include:

Lorigerlimab is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. During the first quarter of 2022, the Company initiated a combination study of MGC018 with lorigerlimab in patients with various solid tumors. MacroGenics is also conducting a Phase 1/2 dose expansion study with lorigerlimab as monotherapy in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), mCRPC, melanoma and checkpoint-naïve NSCLC. MacroGenics anticipates sharing data from this ongoing study in the second half of 2022.
Bispecific CD123 × CD3 DART molecule: MacroGenics is developing an investigational, next-generation CD123 × CD3 DART molecule. Recent updates include:

MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. In April, MacroGenics’ IND application for MGD024 was cleared by the FDA for evaluation in patients with hematologic malignancies. The Company expects to begin enrollment in a Phase 1 study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia (AML) in mid-2022.
Other Program Updates:

Teplizumab is an investigational, anti-CD3 monoclonal antibody acquired from MacroGenics by Provention Bio, Inc. under an asset purchase agreement in 2018 for which MacroGenics is entitled to receive future milestone payments and royalties on net sales. Provention is developing teplizumab for the treatment of type 1 diabetes (T1D). On March 21, 2022, Provention announced that the FDA had accepted the Biologics License Application (BLA) for teplizumab for the delay of clinical T1D in at-risk individuals. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2022.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2022, were $184.0 million, compared to $243.6 million as of December 31, 2021.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $11.1 million for the quarter ended March 31, 2022, compared to total revenue of $16.9 million for the quarter ended March 31, 2021. Revenue for the quarter ended March 31, 2022 included $3.6 million net sales of MARGENZA. The Company continues to have modest expectations for MARGENZA sales.
R&D Expenses: Research and development expenses were $61.4 million for the quarter ended March 31, 2022, compared to $53.1 million for the quarter ended March 31, 2021. The increase was primarily related to development, manufacturing and clinical trial costs related to MGC018, development of discovery projects and preclinical molecules, and increased clinical expenses related to lorigerlimab. These increases were partially offset by decreased development, manufacturing and clinical trial costs related to flotetuzumab (which development has been discontinued), decreased margetuximab manufacturing costs related to the Zai Lab agreement, and decreased retifanlimab manufacturing costs for Incyte.
SG&A Expenses: Selling, general and administrative expenses were $16.3 million for the quarter ended March 31, 2022, compared to $15.0 million for the quarter ended March 31, 2021. The increase was primarily related to MARGENZA selling costs, as well as stock-based compensation and consulting expenses.
Net Loss: Net loss was $66.4 million for the quarter ended March 31, 2022, compared to net loss of $51.3 million for the quarter ended March 31, 2021.
Shares Outstanding: Shares outstanding as of March 31, 2022 were 61,333,074.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of March 31, 2022, plus anticipated and potential collaboration payments, and product revenues should enable it to fund its operations through 2023. The Company’s expected funding requirements do not reflect anticipated expenditures related to the full Phase 2/3 development of MGC018 in mCRPC anticipated to begin by year-end 2022, or further expansion of other studies currently ongoing. However, the Company believes that it can reasonably obtain funding for the planned Phase 2 portion of the MGC018 study through a combination of existing financial resources, a variety of external funding or potential revenue sources, and project prioritization.
Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. (ET) to discuss financial results for the quarter ended March 31, 2022, and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 6791448.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.