FOR IMMEDIATE RELEASE
- First affected person dosed in firm’s first registration-directed research of AFM13 for sufferers with relapsed/refractory peripheral T cell lymphoma (pTCL)
- FDA clearance of investigational new drug utility for first-in-human research of AFM24
- Genentech exercised remaining possibility for unique goal underneath strategic oncology collaboration; triggers a fee in an undisclosed quantity to Affimed from Genentech
- Appoints Cassandra Choe-Juliak, MD, MS as Appearing Chief Medical Officer to succeed Leila Alland, MD; Dr. Alland to stay a advisor for the corporate
- Professional forma money place of €106 million, together with roughly €29 million in internet proceeds from accomplished public providing in November 2019
Heidelberg, Germany, November 19, 2019 – Affimed N.V. (AFMD), a medical stage biopharmaceutical firm dedicated to giving sufferers again their innate capacity to struggle most cancers, right this moment reported monetary outcomes for the quarter ended September 30, 2019 and supplied an replace on medical and company developments.
“We’re excited to begin affected person dosing in our Part 2 research of AFM13 in assist of registration, bringing us one step nearer to delivering a possible new remedy for pTCL sufferers, who’ve only a few remedy choices,” stated Dr. Adi Hoess, Affimed’s CEO. “As well as, the IND for the primary ever medical trial bringing collectively an innate cell engager (AFM13) and adoptive NK cell switch has cleared. This research of AFM13 and MD Anderson’s NK cell product may deal with a much wider group of sufferers with CD30-expressing lymphomas, together with Hodgkin lymphoma, cutaneous T-cell lymphoma and diffuse giant B-cell lymphoma.”
- In November 2019, the primary affected person was dosed in a Part 2 registration-directed research of AFM13 as monotherapy in relapsed or refractory sufferers with CD30-positive peripheral T cell lymphoma (pTCL). The outcomes of the research, if constructive, may kind the idea for a Biologics License Utility submission and assist an accelerated approval given the unmet medical want for protected and efficient new remedies on this hard-to-treat affected person inhabitants. The research may also enroll a cohort of sufferers with reworked mycosis fungoides, an aggressive subtype of cutaneous T cell lymphoma.
- The U.S. Meals and Drug Administration (FDA) cleared an investigational new drug utility (IND) for an investigator-sponsored Part 1 research, wherein the College of Texas MD Anderson Most cancers Heart (MDACC) plans to analyze the mix of AFM13 with allogeneic NK cells. MDACC intends to manage a steady complicated of AFM13 pre-mixed with wire blood-derived allogeneic NK cells in numerous doses (numbers of pre-loaded NK cells) to sufferers with relapsed/refractory CD30-positive lymphoid malignancies. The mix represents a novel strategy to additional enhance response charges and sturdiness of responses on this affected person inhabitants.
·In October 2019, Affimed obtained clearance of its IND for AFM24 from the FDA, enabling the corporate to proceed with its deliberate Part 1/2a medical research of the tetravalent, bispecific epidermal progress issue receptor (EGFR)- and CD16A-binding innate cell engager in sufferers with superior cancers identified to precise EGFR. The clearance of the IND follows the corporate’s IND submission in late-September 2019. Affimed expects the research, which is geared toward establishing security and figuring out preliminary alerts of efficacy of AFM24, to provoke within the first quarter of 2020.
·Affimed chosen two new CD16A-binding innate cell engager candidates (AFM28 and AFM32) from our ROCK® platform for undisclosed targets that the corporate plans to advance into preclinical research in 2020 with the intention of supporting future IND submissions. The collection of the brand new improvement candidates follows Affimed’s analysis of innate immune cell exercise versus a lot of potential targets which are expressed in a number of hematological and stable tumor malignancies.
·In November 2019, Genentech exercised its remaining possibility for an unique goal underneath the continuing, multi-program strategic oncology collaboration settlement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK® platform to deal with a number of cancers. The goal choice triggers a fee in an undisclosed quantity to Affimed from Genentech.
·Affimed introduced the appointment of Cassandra Choe-Juliak, MD, MS as Appearing Chief Medical Officer to succeed Dr. Leila Alland, efficient November 30, 2019. Dr. Alland will transition out of her present position and can function a advisor for the corporate. Dr. Choe-Juliak has over 13 years of expertise in drug improvement and medical affairs in immuno-oncology/oncology for each hematological and stable tumor malignancies. Since becoming a member of Affimed in July 2017, she has served because the medical chief for the AFM13 improvement program.
Dr. Hoess commented, “Cassandra’s deep experience in drug improvement and robust management abilities have been, and can proceed to be, an amazing asset to Affimed and our medical workforce as we advance our pipeline of innate cell engagers. I might additionally prefer to thank Leila for her many contributions to Affimed and need her success in her future endeavors.”
(Figures for the third quarter and 9 months ended September 30, 2019 and 2018 are unaudited.)
Money, money equivalents and present monetary belongings totaled €76.5 million as of September 30, 2019, in comparison with €108.eight million as of December 31, 2018. In November 2019, Affimed accomplished a public fairness providing with internet proceeds, after deducting underwriting reductions and commissions and estimated providing bills, of roughly $32 million (€29 million). Based mostly on its present working and funds assumptions, the corporate anticipates that its money, money equivalents and present monetary belongings as of September 30, 2019, along with the proceeds from the inventory providing, will allow the Firm to fund its deliberate medical improvement and early improvement actions no less than into the fourth quarter of 2021.
Web money utilized in working actions was €30.6 million for the 9 months ended September 30, 2019, in comparison with internet money utilized in working actions of €24.9 million for the 9 months ended September 30, 2018. The rise is primarily because of larger money expenditure for analysis and improvement efforts.
Complete income was €2.1 million for the three months ended September 30, 2019 in comparison with €zero.three million for the three months ended September 30, 2018. The rise in income is attributable to the popularity of €1.9 million as income from the Genentech collaboration within the third quarter of 2019.
Analysis and improvement (R&D) bills for the third quarter of 2019 have been €11.7 million, in comparison with R&D bills for the third quarter of 2018 of €9.eight million. The rise was primarily associated to larger bills associated to manufacturing actions for medical research materials for AFM13, startup actions for the AFM13 registration research in pTCL and early stage improvement and discovery actions.
Basic and administrative bills for the third quarter of 2019 have been €2.eight million in comparison with €2.four million for the third quarter of 2018.
Web loss was €10.9 million, or €zero.17 per widespread share, for the third quarter of 2019, in comparison with a internet lack of €12.zero million, or €zero.19 per widespread share, for the third quarter of 2018.
Be aware on Worldwide Monetary Reporting Requirements (IFRS)
Affimed prepares and reviews the consolidated monetary statements and monetary info in accordance with IFRS as issued by the Worldwide Accounting Requirements Board. Not one of the monetary statements have been ready in accordance with Usually Accepted Accounting Rules in america. Affimed maintains its books and information in Euro.
Convention Name and Webcast Info
Affimed will host a convention name and webcast right this moment, Tuesday, November 19, 2019 at eight:30 a.m. Japanese time to debate the corporate’s monetary outcomes and up to date company developments. To entry the decision, please dial +1 (631) 510-7495 for U.S. callers, or +44 (zero) 2071 928000 for worldwide callers, and reference convention ID 8758067 roughly 15 minutes previous to the decision. An audio webcast of the convention name may be accessed within the “Webcasts” part on the “Buyers” web page of the Affimed web site at https://www.affimed.com/investors/webcasts_cp/. A replay of the webcast might be out there on Affimed’s web site shortly after the conclusion of the decision and might be archived for 30 days following the decision.
About Affimed N.V.
Affimed (AFMD) is a medical stage biopharmaceutical firm dedicated to giving sufferers again their innate capacity to struggle most cancers. Affimed’s fit-for-purpose ROCK® platform permits innate cell engagers to be designed for particular affected person populations. The Firm is creating single and mixture therapies to deal with hematologic and stable tumors. For extra info, please go to www.affimed.com.
This press launch accommodates forward-looking statements. All statements aside from statements of historic truth are forward-looking statements, which are sometimes indicated by phrases equivalent to “anticipate,” “consider,” “may,” “estimate,” “anticipate,” “aim,” “intend,” “stay up for”, “might,” “plan,” “potential,” “predict,” “mission,” “ought to,” “will,” “would” and related expressions. Ahead-looking statements seem in a lot of locations all through this launch and embody statements concerning our intentions, beliefs, projections, outlook, analyses and present expectations regarding, amongst different issues, the worth of our ROCK® platform, our ongoing and deliberate preclinical improvement and medical trials, our collaborations and improvement of our merchandise together with different therapies, the timing of and our capacity to make regulatory filings and procure and preserve regulatory approvals for our product candidates our mental property place, our collaboration actions, our capacity to develop industrial capabilities, expectations concerning medical trial information, our outcomes of operations, money wants, monetary situation, liquidity, prospects, future transactions, progress and methods, the trade wherein we function, the traits which will have an effect on the trade or us and the dangers, uncertainties and different components described underneath the heading “Danger Components” in Affimed’s filings with the Securities and Trade Fee. Given these dangers, uncertainties and different components, you shouldn’t place undue reliance on these forward-looking statements, and we assume no obligation to replace these forward-looking statements, even when new info turns into out there sooner or later.
Affimed Investor and Media Contact:
Gregory Gin, Head of Investor Relations
Unaudited consolidated statements of complete earnings/(loss) (in € 1000’s)
| For the three months
ended September 30
| For the 9 months
ended September 30
|Different earnings – internet||49||(259)||332||(221)|
|Analysis and improvement bills||(11,721)||(9,787)||(31,253)||(23,332)|
|Basic and administrative bills||(2,790)||(2,389)||(7,566)||(6,591)|
|Working earnings / (loss)||(12,359)||(12,129)||(21,zero23)||(29,156)|
|Finance earnings / (prices) – internet||1,475||109||1,655||920|
|Loss earlier than tax||(10.884)||(12,zero20)||(19,368)||(28,236)|
|Loss for the interval||(10,884)||(12,zero20)||(19,372)||(28,237)|
| Different complete earnings / (loss)
Objects that won’t be reclassified to revenue or loss
Fairness investments at honest worth
OCI – internet change in honest worth
|Different complete earnings / (loss)||(555)||53||(531)||264|
|Complete complete loss||(11,439)||(11,967)||(19,903)||(27,973)|
Loss per share in € per share
|(undiluted = diluted)|
|Weighted variety of widespread shares excellent||62,443,550||62,400,484 62,437,673||59,876,197|
Consolidated statements of economic place (in € 1000’s)
|September 30, 2019||December 31, 2018|
|Leasehold enhancements and tools||2,zero21||1,414|
|Long run monetary belongings||three,294||three,825|
|Money and money equivalents||59,995||94,829|
|Commerce and different receivables||1,184||1,429|
|EQUITY AND LIABILITIES|
|Honest worth reserves||2,063||2,594|
|Complete non-current liabilities||34,164||39,202|
|Commerce and different payables||7,633||9,425|
|Complete present liabilities||29,153||36,843|
|TOTAL EQUITY AND LIABILITIES||85,550||116,174|
Unaudited consolidated statements of money flows (in € 1000’s)
| For the 9 months ended
|Money movement from working actions|
|Loss for the interval||(19,372)||(28,237)|
|Changes for the interval:|
|– Revenue taxes||four||1|
|– Depreciation and amortization||648||303|
|– Web achieve from disposal of leasehold enhancements and tools||(9)||15|
|– Share based mostly funds||1,981||1,523|
|– Finance earnings / prices – internet||(1,655)||(920)|
|Change in commerce and different receivables||458||(344)|
|Change in inventories||(70)||(79)|
|Change in different belongings||(1,104)||(549)|
|Change in commerce, different payables, provisions and contract liabilities||(11,727)||three,473|
|Money utilized in working actions||(30,846)||(24,814)|
|Paid earnings tax||zero||(1)|
|Web money utilized in working actions||(30,613)||(24,924)|
|Money movement from investing actions|
|Buy of intangible belongings||(143)||(27)|
|Buy of leasehold enhancements and tools||(926)||(448)|
| Money obtained from the sale of leasehold enhancements
|Money paid for investments in monetary belongings||(39,733)||zero|
|Money obtained from maturity of economic belongings||38,270||zero|
|Web money used for investing actions||(2,532)||(474)|
|Money movement from financing actions|
|Proceeds from subject of widespread shares||26||25,110|
|Transaction prices associated to subject of widespread shares||zero||(1,702)|
|Proceeds from borrowings||562||zero|
|Compensation of lease liabilities||(299)||zero|
|Compensation of borrowings||(2,339)||(2,250)|
|Money movement from financing actions||(2,zero50)||21,158|
|Trade-rate associated adjustments of money and money equivalents||361||1,479|
|Web adjustments to money and money equivalents||(35,195)||(four,240)|
|Money and money equivalents firstly of the interval||94,829||39,837|
|Money and money equivalents on the finish of the interval||59,995||37,076|
Unaudited consolidated statements of adjustments in fairness (in € 1000’s)
|Issued capital||Capital reserves||
Honest Worth reserves
|Stability as of January 1, 2018||468||213,778||
Difficulty of widespread shares
|Train of share based mostly fee awards||68||68|
| Fairness-settled share based mostly
|Loss for the interval||
|Different complete earnings||264||264|
|Stability as of September 30, 2018||
Stability as of January 1, 2019
|Train of share based mostly fee awards||26||26|
| Fairness-settled share based mostly
|Loss for the interval||(19,372)||(19,372)|
|Different complete earnings||(531)||(531)|
|Stability as of September 30, 2019||