LUND, Sweden, Feb. 23, 2021 /PRNewswire/ — “BioInvent has began 2021 with important optimistic momentum We reported promising interim efficacy knowledge from the continued Part I/IIa trial of our lead drug candidate BI-1206.The corporate additionally closed a profitable SEK 962 million financing spherical, increasing our institutional shareholder base. Moreover, we introduced the growth of our medical pipeline to incorporate two additional drug candidates for the therapy of strong tumors.” – Martin Welschof, CEO BioInvent
Fourth quarter 2020
– Internet gross sales SEK 98.7 (25.4) million.
– Revenue/loss after tax SEK 28.5 (-40.9) million.
– Revenue/loss after tax per share earlier than and after dilution SEK 0.74 (-2.04).
– Money circulation from working actions and funding actions SEK 27.6 (-28.5) million.
January – December 2020
– Internet gross sales SEK 147.4 (93.7) million.
– Loss after tax SEK -76.3 (-138.6) million.
– Loss after tax per share earlier than and after dilution SEK -2.66 (-7.64).
– Money circulation from working actions and funding actions SEK -69.3 (-129.3) million. Liquid funds as of December 31, 2020: SEK 729.3 (154.0) million.
Monetary data first quarter 2020
– Internet gross sales SEK 16.7 (17.4) million.
– Loss after tax SEK -32.6 (-27.8) million.
– Loss after tax per share earlier than and after dilution SEK -0.07 (-0.08).
– Money circulation from working actions and funding actions SEK -35.4 (-40.5) million. Liquid funds as of March 31, 2020: SEK 117.1 (28.5) million.
Occasions within the fourth quarter
- BI-1206 was out-licensed to CASI Prescription drugs for the Larger China area. The collaboration accelerates and expands BioInvent’s world growth plans for BI-1206. BioInvent acquired $12 million upfront together of money and fairness funding and is eligible to obtain as much as $83 million in milestone funds, plus tiered royalties. The fairness funding was authorized at an EGM held on November 27, 2020. (R)
- BioInvent acquired a $3 million milestone fee associated to number of antibodies beneath its collaboration with Pfizer. (R)
- Approval of a CTA was acquired in Denmark for the Part I/IIa examine of BI-1808, as monotherapy and together with the anti-PD-1 remedy KEYTRUDA® (pembrolizumab) for the therapy of strong tumors and cutaneous T-cell lymphoma (CTCL).
- BioInvent and Transgene acquired CTA approval for Part l/lla trial of oncolytic virus BT-001 in strong tumors.
- New preclinical knowledge was offered on BI-1808 and BT-001 on the SITC thirty fifth Anniversary Annual Assembly. New promising medical and preclinical knowledge on BI-1206 was additionally offered on the ASH Annual Assembly.
- BioInvent acquired a €2 million milestone fee beneath its collaboration with Daiichi Sankyo associated to the initiation of a worldwide Part I medical trial with a GARP directed antibody. (R)
- BioInvent and Cantargia signed a producing settlement, which can generate income for BioInvent of as much as SEK 30 million.
- BioInvent introduced the appointment of Cecilia Hofvander as Senior Director Investor Relations, a brand new place at BioInvent beginning mid-February 2021.
- The EGM held on November 27, 2020 authorized the proposal on a reverse share break up 1:25, a discount of the share capital to regulate the share capital to the Firm’s operations, and an up to date authorization for the Board to determine on a brand new difficulty of shares comprising 4,375,121 shares (after the reverse share break up). (R)
Occasions after the reporting interval
- In January 2021, BioInvent introduced that Part I/IIa knowledge counsel that BI-1206 restores exercise of rituximab in relapsed non-Hodgkin’s lymphoma sufferers. Responses in 6 out of 9 sufferers evaluated present thrilling proof that BI-1206 has the potential to revive exercise of rituximab in non-Hodgkin’s lymphoma sufferers who’ve relapsed after therapy with rituximab. Lengthy-lasting full responses noticed in two sufferers past 12 months. (R)
- On February 23, 2021, BioInvent efficiently accomplished a directed share difficulty of roughly SEK 962 million earlier than transaction prices. Buyers within the directed share difficulty are a spread of worldwide and Swedish buyers, together with Redmile Group, LLC., Invus, HBM Healthcare Investments, The Fourth Nationwide Swedish Pension Fund, Swedbank Robur Fonder and Van Herk Investments. 2,834,399 new shares had been issued based mostly on the authorization granted by the EGM on November 27, 2020, and 16,260,601 new shares had been issued topic to the approval of an EGM to be held on 23 March 2021. (R)
- In January 2021, BioInvent introduced that it had restructured a medical growth settlement with Most cancers Analysis UK (CRUK) for BI-1206. In trade for a one-time fee of £2.5 million, the revised deal simplifies and reduces Bioinvent’s obligations to CRUK. (R)
- BioInvent introduced in January 2021, enrollment of the primary affected person in a Part I/IIa examine of BI-1808.
- o In January 2021, BioInvent introduced that An van Es Johansson ought to resign as a director of the board efficient as of 15 February 2021, because of private causes. (R)
(R)= Regulatory occasion
Feedback from the CEO
BioInvent has began 2021 with important optimistic momentum. Promising interim efficacy knowledge from the continued Part I/IIa trial of our lead drug candidate BI-1206 was adopted by a profitable financing spherical, including one other specialised institutional proprietor to the corporate. Moreover, we introduced the growth of our medical pipeline to incorporate two additional drug candidates.
The information from the examine of BI-1206, together with rituximab in sufferers with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL), are very encouraging. The responses in these severely sick sufferers counsel that BI-1206 could restore the response to rituximab in sufferers who’ve few therapy options. Moreover, the period of full response in two sufferers are significantly spectacular and point out that BI-1206 has the potential to considerably enhance the lives of NHL sufferers who’ve progressed after earlier traces of therapy.
We had been proud to host a key opinion chief (KOL) occasion on these outcomes with famend lymphoma skilled Professor Mats Jerkeman, MD, of Lund College. Primarily based on these outcomes, we’ll now transfer to establish the really useful dose for the Part IIa a part of the examine. We additionally offered new knowledge on BI-1206 on the ASH Annual Assembly in December and are excited to additional consider its potential to carry a lot wanted innovation to lymphoma sufferers.
This progress is bolstered by our partnership with CASI Prescription drugs for the event and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau. Underneath this settlement for each liquid and strong cancers, BioInvent acquired $12 million upfront together of money and fairness funding and is eligible to obtain as much as $83 million in growth and industrial milestone funds plus tiered royalties within the high-single to mid-double-digit vary on internet gross sales. CASI is a confirmed chief in China and their medical growth and regulatory experience will likely be necessary in producing further knowledge on BI-1206.
Now we have simplified and decreased our obligations to CRUK associated to BI-1206 by restructuring our medical growth settlement with CRUK (Most cancers Analysis UK) for BI-1206, in trade for a one-time fee. This gives us with additional flexibility to hold out growth and partnering actions with BI-1206.
Our modern pipeline is increasing past BI-1206. We now have three merchandise in medical growth, underlining the flexibility of our n-CoDeR®/F.I.R.S.T™ platforms to supply novel, differentiating drug candidates.
In January, we enrolled the primary affected person in a Part I/IIa, first-in-human examine of BI-1808, a first-in-class anti-TNFR2 antibody, as monotherapy and together with the anti-PD-1 remedy Keytruda® (pembrolizumab) for the therapy of strong tumors and CTCL. That is based mostly on a strong preclinical knowledge set for BI-1808, together with the brand new knowledge offered on the thirty fifth Annual Assembly of SITC in November.
Now we have now acquired CTA approval to begin a Part I/IIa medical trial of the novel oncolytic vaccinia virus BT-001 in strong tumors, via our collaboration with Transgene. BT-001 combines a number of mechanisms of motion and has excellent potential in a variety of indications because of its mixture of a number of anti-cancer properties. We additionally offered new knowledge on BT-001 at SITC.
On February 23, we additional bolstered our monetary place with a directed share difficulty that raised roughly SEK 962 million earlier than transaction prices. These proceeds intend to fund the continued transformation of BioInvent and growth of our medical packages. Assuming continued era of optimistic knowledge, we plan to specifically use the funds to organize a pivotal medical trial of BI-1206 for the therapy of NHL, with the purpose of receiving an accelerated regulatory pathway. We additionally anticipate to develop the medical packages of BI-1206 together with Keytruda® and BI-1808 as monotherapy and together with Keytruda®.
Our associate Pfizer has chosen antibodies, directed at a beforehand chosen goal, beneath our settlement masking creating antibodies from the F.I.R.S.TTM drug discovery platform concentrating on tumor-associated myeloid cells. That is a powerful instance of the productiveness of our platform and additional strengthens our monetary place by $3 million. We could now transfer ahead to develop different antibodies internally or with different companions.
We additionally generated necessary income from a €2 million milestone fee beneath a collaboration with Daiichi Sankyo and we signed a brand new manufacturing settlement with Cantargia, beneath which BioInvent could generate income of as much as SEK 30 million.
As beforehand communicated, BioInvent has taken all the mandatory precautions as regards to managing the impression of Covid-19. Though we nonetheless observe viral unfold all through the neighborhood, which is in fact horrible for all these affected and their households, we stay on observe with our medical trials and outcomes. Because the state of affairs remains to be evolving, timelines could also be impacted in geographic areas most severely affected. We are going to present updates as obligatory.
The corporate has made important progress in delivering on our technique in 2020 and this has set us up for various necessary milestones as we progress our portfolio via medical growth. 2021 guarantees to be a really thrilling 12 months for BioInvent.
Martin Welschof, CEO
Learn the entire report within the hooked up pdf.
BioInvent Worldwide AB (publ)
Co. reg. no. 556537-7263
Tackle: Sölvegatan 41, 223 70 Lund
Tel.: +46 (0)46 286 85 50
Ahead trying data
This interim report comprises statements concerning the future, consisting of subjective assumptions and forecasts for future situations. Predictions for the long run solely apply as of the date they’re made and are, by their very nature, in the identical approach as analysis and growth work within the biotech phase, related to threat and uncertainty. With this in thoughts, the precise out-come could deviate considerably from the situations described on this interim report.
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